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Trial registered on ANZCTR
Registration number
ACTRN12624000893505
Ethics application status
Approved
Date submitted
11/06/2024
Date registered
22/07/2024
Date last updated
22/07/2024
Date data sharing statement initially provided
22/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Therapeutic intervention for intimate partner violence survivors with PTSD
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Scientific title
Aerobic Exercise as a Therapeutic Intervention for Women Who Have Experienced Intimate Partner Violence (IPV) with Post-traumatic Stress Disorder (PTSD)
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Secondary ID [1]
311590
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Injury in Intimate Partner Survivors
332973
0
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PTSD
332974
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Condition category
Condition code
Neurological
329685
329685
0
0
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Other neurological disorders
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Mental Health
329686
329686
0
0
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Studies of normal psychology, cognitive function and behaviour
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Injuries and Accidents
329687
329687
0
0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Women with a history of intimate partner violence will be contacted with consent from previous studies to confirm eligibility for this study. Only participants who meet all inclusion and exclusion criteria will be recruited for the initial visit.
During the screening visit, participants will be interviewed in one-on-one sessions and asked to complete questionnaires for data collection and confirmation of the inclusion criteria described below:
The Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5): to evaluate PTSD and proceed with admission only for participants who score 30 or higher.
Participants will also be asked to perform the Buffalo Concussion Bike Test (BCBT), a graded exertion test for assessing exercise tolerance after a concussion. During this test, participants will cycle on a stationary bike. Every two minutes, the exercise intensity will increase for a maximum of 30 minutes. Every 2 minutes, participants will also indicate their symptom severity using the Visual Analogue Scale (VAS) and perceived exertion on the Borg Ratings of Perceived Exertion (RPE) scale (6-20). Heart rate will be recorded using a Fitbit (Inspire 3) and an electrocardiogram (ECG). This test identifies the heart rate (HR) at which symptom exacerbation occurs (i.e., Heart Rate Threshold [HRt]).
Based on the results of the BCBT, participants will be allocated into three possible interventions:
Exercise Intolerant Group: Participants who are exercise intolerant will be randomly assigned to one of two groups in a parallel design. One group will receive a 4-week sub-symptom threshold aerobic exercise (STAE) intervention (20 minutes per day), while the other group will receive a placebo-like passive stretching intervention (allocation ratio 1:1). The STAE target HR will be 80% of the HR achieved at symptom exacerbation during the most recent BCBT visit.
Exercise Tolerant Group: Participants who are exercise tolerant will be randomly assigned to one of two groups in a parallel design. One group will receive a 4-week standard aerobic exercise intervention, while the other will receive a placebo-like passive stretching intervention (allocation ratio 1:1). Participants will be instructed to complete 20 minutes of aerobic exercise daily at home or in a gym at the prescribed target HR, The prescribed heart rate will be 50-65% of the age-predicted maximum heart rate.
Participants assigned to either the STAE intervention or the standard aerobic exercise intervention (AE) have the option to exercise at home or at a gym. They can choose to perform the STAE or AE intervention in any way they prefer, such as walking, jogging, or stationary cycling, but they will be advised to minimize neck motion during exercise. Both interventions consist of a 5-minute warm-up, a minimum of 20 minutes at the designated heart rate, and then a 5-minute cool-down.
All participants will be provided with an activity tracker (Fitbit Inspire 3) to monitor their heart rate and adherence to the protocol.
Using the Fitabase platform, research staff will have daily access to participants' activity tracker data, including intensity, heart rate, and exercise logs. Participants will also be asked to complete a weekly survey to confirm adherence to the protocol.
All participants, regardless of the treatment group, will be reassessed weekly for exercise tolerance. Upon completing the initial 4 weeks, participants in either treatment group will be offered an additional 4 weeks of the intervention, with all processes repeated to assess any changes over an 8-week timeframe. Data from these optional assessments will be analysed together with the data from the first 4 weeks.
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Intervention code [1]
328044
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Behaviour
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Intervention code [2]
328930
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Treatment: Other
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Intervention code [3]
328931
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Diagnosis / Prognosis
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Comparator / control treatment
Control: Participants will perform a 20-minute daily stretching intervention. They will be provided with a booklet containing daily stretching exercises, including Triceps Stretch, Pelvic Tilts, Piriformis Stretch, etc.
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Control group
Active
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Outcomes
Primary outcome [1]
337472
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Post traumatic Stress Disorder Symptom Burden
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Assessment method [1]
337472
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The Post traumatic Stress Disorder Checklist (PCL-5)
The Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of the twenty DSM-5 symptoms of PTSD in adult populations (ages 18+). It is designed for use with people who have experienced traumatic events.
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Timepoint [1]
337472
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Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Primary outcome [2]
337473
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Quality of life
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Assessment method [2]
337473
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WORLD HEALTH ORGANISATION- QUALITY OF LIFE (WHOQOL- BREF)
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
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Timepoint [2]
337473
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Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [1]
432007
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Exercise Tolerance
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Assessment method [1]
432007
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Exercise tolerance will be assessed using the Buffalo Concussion Bike Test (BCBT). During this test, participants are asked to cycle on a stationary seated bike. Every two minutes, the exercise intensity will increase for a maximum of 30 minutes. Every 2 minutes, participants will also indicate their symptom severity using the Visual Analogue Scale (VAS) and perceived exertion on Borg Ratings of Perceived Exertion (RPE) 6–20 (lowest to highest). Heart rate will be recorded with the Fitbit (Inspire 3) and electrocardiogram (ECG). This test identifies the heart rate (HR) at which symptom exacerbation occurs (i.e., Heart Rate Threshold [HRt]).
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Timepoint [1]
432007
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [2]
432008
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Depression, Anxiety and Stress
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Assessment method [2]
432008
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Depression, Anxiety & Stress Symptom Scale (DASS-21)
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 7 items, divided into subscales of 2-5 items with similar content. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week.
Scores for Depression, Anxiety, and stress will be assessed together by summing the scores for the relevant items.
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Timepoint [2]
432008
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [3]
432009
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Complex Post-Traumatic Stress Disorder
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Assessment method [3]
432009
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International Trauma Questionnaire (ITQ): The International Trauma Questionnaire (ITQ) is an 18 question self-report measure focusing on the core features of Post Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). It was developed to be consistent with the organizing principles of the ICD-11.
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Timepoint [3]
432009
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [4]
432010
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Substance use
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Assessment method [4]
432010
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Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite)
The ASSSIT-Lite is a short-form version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), that can be used to screen for a range of drugs of concern.
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Timepoint [4]
432010
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [5]
432011
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Pain
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Assessment method [5]
432011
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Brief Pain Inventory: The Brief Pain Inventory (BPI) consists of 15 items and measures pain intensity and interference.
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Timepoint [5]
432011
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [6]
432012
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General Health
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Assessment method [6]
432012
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12-item Short Form Health Survey (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life.
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Timepoint [6]
432012
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [7]
432013
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Sleep Quality
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Assessment method [7]
432013
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Sleep-Related Impairment Short-Form (SRI): 8 five-point scale items measuring impairment in daily functioning due to poor sleep (i.e., impact of poor sleep). Items rated in context of the past week.
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Timepoint [7]
432013
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [8]
432015
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Assessment of working and long-term memory, learning and recognition
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Assessment method [8]
432015
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Rey Auditory Verbal Learning Test (RAVLT): Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the client must again repeat the original list of 15 words and then again after 30 minutes. Approximately 10 to 15 minutes is required for the procedure (not including 30 min. interval)
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Timepoint [8]
432015
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [9]
432016
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Axonal injury
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Assessment method [9]
432016
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Blood protein levels of neurofilament light and tau
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Timepoint [9]
432016
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [10]
432017
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Saliva biomarkers
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Assessment method [10]
432017
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DNA/RNA Extraction: Telomere length
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Timepoint [10]
432017
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [11]
432018
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Compliance and Adherence
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Assessment method [11]
432018
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A weekly follow-up survey designed specifically for this study, composed of 13 items divided into three subscales: General Health (changes in health, addition of new medications, tracking of the menstrual cycle), Adverse Events Report (if needed), and Adherence to Study Protocol (usage of the activity tracker, completion of exercise sessions, consistency).
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Timepoint [11]
432018
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [12]
432019
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Safety and Tolerability
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Assessment method [12]
432019
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A weekly follow-up survey designed specifically for this study, composed of 13 items divided into three subscales: General Health (changes in health, addition of new medications, tracking of the menstrual cycle), Adverse Events Report, and Adherence to Study Protocol (usage of an activity tracker, completion of exercise sessions, consistency).
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Timepoint [12]
432019
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [13]
437302
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Assessment of Attention & Working Memory
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Assessment method [13]
437302
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WAIS-IV Working Memory Index – subtests Digit Span: Three tasks assessing digit repetition forwards, backwards and sequencing.
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Timepoint [13]
437302
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [14]
437303
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Assessment of Processing Speed
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Assessment method [14]
437303
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Oral Symbol Digit Modalities Task: 90-second task on symbol decoding. Oral format utilised.
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Timepoint [14]
437303
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [15]
437304
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Assessment of Speed & Switching (Executive Function)
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Assessment method [15]
437304
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Trail making test (TMT): Two-part task requiring joining the dots on a written form both in simple (1-2-3-4) & complex sequencing (1-A, 2-B, 3-C, 4-D). Task is timed.
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Timepoint [15]
437304
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [16]
437305
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Assessment of pre-morbid cognitive & memory functioning
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Assessment method [16]
437305
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Test of Premorbid Functioning (TOPF): The purpose of the TOPF is to estimate preinjury intellectual level based on an individual's ability to read words that lack graphemic-phonemic correspondence
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Timepoint [16]
437305
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Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
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Secondary outcome [17]
437306
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Inflammatory factors
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Assessment method [17]
437306
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Blood protein levels of IL-1ß, IL-18
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Timepoint [17]
437306
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [18]
437307
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Growth factors
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Assessment method [18]
437307
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Blood protein levels of vascular endothelial growth factor (VEGF), brain-derived neurotrophic factor (BDNF)
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Timepoint [18]
437307
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [19]
437308
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Astrocyte damage
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Assessment method [19]
437308
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Blood protein levels of Glial fibrillary acidic protein (GFAP)
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Timepoint [19]
437308
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Secondary outcome [20]
437309
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Biomarkers associated with PTSD
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Assessment method [20]
437309
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Blood protein levels of endocannabinoid signaling system (ECSS)
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Timepoint [20]
437309
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Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
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Eligibility
Key inclusion criteria
Female participants aged between 18-70 years providing informed consent
Self-report history of IPV (> 3 months)
Probable post-traumatic stress disorder as measured by Post traumatic Stress Disorder Checklist PCL-5
Have daily access to a smartphone and internet
Eligible for Medicare
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Subjects who are not willing or able to exercise due to health or personal reasons (e.g. orthopaedic injury, cervical spine injury, diabetes, known heart disease or musculoskeletal injuries which could make exercise difficult or painful) via Physical Activity Readiness questionnaire used (PAR-Q).
Increased cardiac risk indicated by two or more of the following:
a) Prior diagnosis of, or currently taking medication for cardiovascular (e.g., beta-blockers), metabolic or pulmonary conditions;
b) Family history of myocardial infarction, coronary revascularisation or sudden death before 55 years;
c) Diagnosis of hypertension;
d) Diagnosis of hyperlipidemia;
e) Subjects with peripheral circulatory disorders.
History of prior head injury as defined by:
a) Any head injury within the last 30 days
b) Moderate or severe TBI, defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less
Diagnosis of a neurological (e.g., stroke, multiple sclerosis, epilepsy, brain tumour/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus)
History of drug or alcohol dependency or abuse within a year before screening by self-report
Limited English proficiency precluding completion of measures
Significant psychiatric history (e.g. psychiatric hospitalisation, schizophrenia, history of legal trouble for violence)
IPV history < 3 month
No PTSD symptomology at the initial visit (i.e., asymptomatic).
Sustaining another head injury during the research period
New (< 1 month) or non-stable or pharmacological regimen prior to intervention (regiment must be maintained for the duration of intervention)
Exercise-tolerant individuals with a current activity level equal to or greater than the proposed intervention
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer-generated randomization schedule will be prepared by a statistician prior to the start of the study. Treatment allocation will be made per the randomization list. After signing the informed consent form, subjects will be allocated a unique subject ID and administered the screening instruments via REDCap.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women with IPV and PTSD who are exercise intolerant group will involve a randomized parallel groups design comparing the efficacy of 4 weeks of STAE intervention (20 min/day) versus a placebo-like passive stretching intervention (allocation ratio 1:1).
Women with a history of IPV with PTSD who were exercise tolerant group will involve a randomized parallel groups design comparing the efficacy of a 4-week standard AE intervention versus a placebo-like passive stretching intervention (allocation ratio 1:1).
Participants allocated into the placebo groups will undergo 4-weeks of passive stretching and then will be offered to complete the 4-week intervention dependent on their exercise tolerance status.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Participants previously randomized into placebo groups (stretching) will be invited to follow the therapeutic intervention upon completion of the 4-week trial (primary timepoint), based on their most recent results from the Buffalo Concussion Bike Test (BCBT).
Participants who are exercise intolerant, experiencing increased symptomatology while performing exercise tolerance tests, will be instructed to perform 20 minutes of aerobic exercise daily for the additional 4 weeks at a prescribed heart rate (80% of the maximum heart rate achieved when symptoms increase).
Participants who are exercise tolerant will be instructed to complete 20 minutes of aerobic exercise daily for the additional 4 weeks at a prescribed heart rate (50-65% of the age-predicted maximum heart rate).
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size estimates for these trials are between 46-96, with an estimated drop-out rate of 20%. we will recruit 120 participants. In general data will be summarized using descriptive statistics (number of non-missing observations, mean, median, standard deviation, minimum and maximum) or frequency counts and percentages, as appropriate to the type of data.
Unadjusted and adjusted logistic regression models will be used to assess differences in the probability of symptom resolution between graded exercise and passive stretching during the 4 weeks.
To identify that the randomization strategy was effective, analysis of variance will be used to assess for group-wise differences in age, days since injury to initial visit, resting heart rate (HR), and HR during the BCBT. Non-parametric tests of medians will be used to compare the non-normally distributed variable duration of clinical recovery.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
16/05/2024
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Date of last participant enrolment
Anticipated
16/03/2027
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Actual
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Date of last data collection
Anticipated
16/05/2027
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Actual
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Sample size
Target
120
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Accrual to date
4
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26567
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
42609
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
315897
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Government body
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Name [1]
315897
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National Health and Medical Research Council
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Address [1]
315897
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Country [1]
315897
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
318044
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None
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Address [1]
318044
0
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Country [1]
318044
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314744
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
314744
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
314744
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Australia
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Date submitted for ethics approval [1]
314744
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17/10/2023
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Approval date [1]
314744
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14/11/2023
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Ethics approval number [1]
314744
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40295
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Summary
Brief summary
In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Of the many challenges faced by IPV survivors, post-traumatic stress disorder (PTSD) is notable, with an estimated prevalence of up to almost 64% of survivors, irrespective of the type of IPV experienced. Also, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with post-traumatic stress disorder (PTSD). Secondary to this is whether this intervention is effective in women who have experienced intimate partner violence brain injury (IPV-BI) experiencing persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PTSD and PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Georgia Fuller Symons
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Address
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The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
132582
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Australia
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Phone
132582
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+61 0434910441
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Fax
132582
0
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Email
132582
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[email protected]
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Contact person for public queries
Name
132583
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Georgia Fuller Symons
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Address
132583
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The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
132583
0
Australia
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Phone
132583
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+61 0434910441
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Fax
132583
0
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Email
132583
0
[email protected]
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Contact person for scientific queries
Name
132584
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Georgia Fuller Symons
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Address
132584
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The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
132584
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Australia
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Phone
132584
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+61 0434910441
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Fax
132584
0
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Email
132584
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23872
Informed consent form
387381-(Uploaded-03-06-2024-16-08-44)-PICF_Exercise_v4-28-02-2023.pdf
23971
Ethical approval
387381-(Uploaded-09-07-2024-09-38-25)-attachmentEntry-315906 (1).pdf
23997
Other
Stretching Booklet
387381-(Uploaded-16-07-2024-11-29-55)-Exercise for IPV_StretchingBooklet.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF