Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000892516
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 PPCS
Scientific title
Aerobic Exercise as a Therapeutic Intervention for Women Who Have Experienced Intimate Partner Violence (IPV) experiencing Persistent Post-concussion Symptoms (PPCS).
Secondary ID [1] 312279 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injury in Intimate Partner Survivors 334002 0
PPCS 334003 0
Condition category
Condition code
Neurological 330676 330676 0 0
Other neurological disorders
Mental Health 330677 330677 0 0
Studies of normal psychology, cognitive function and behaviour
Injuries and Accidents 330678 330678 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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:
Rivermead Post Concussion Symptom Questionnaire (RPQ): Assess the presence of Persistent Post-Concussion Symptoms (PPCS) meeting the WHO 10th International Classification of Diseases (ICD-10) criteria.

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 (AE), 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.
Intervention code [1] 328742 0
Behaviour
Intervention code [2] 328999 0
Treatment: Other
Intervention code [3] 329000 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 338425 0
Persistent Post-Concussion Symptoms (PPCS) Burden
Timepoint [1] 338425 0
Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Primary outcome [2] 338428 0
Quality of Life
Timepoint [2] 338428 0
Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Primary outcome [3] 338429 0
Exercise Tolerance
Timepoint [3] 338429 0
Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [1] 435888 0
Depression, Anxiety and Stress
Timepoint [1] 435888 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [2] 435889 0
Complex Post-Traumatic Stress Disorder
Timepoint [2] 435889 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [3] 435890 0
Substance use
Timepoint [3] 435890 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [4] 435891 0
Pain
Timepoint [4] 435891 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [5] 435892 0
General Health
Timepoint [5] 435892 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [6] 435893 0
Sleep Quality
Timepoint [6] 435893 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [7] 435894 0
Assessment of working and long-term memory, learning and recognition
Timepoint [7] 435894 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [8] 435895 0
Axonal injury
Timepoint [8] 435895 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [9] 435896 0
Saliva biomarkers
Timepoint [9] 435896 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [10] 435897 0
Compliance and Adherence
Timepoint [10] 435897 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [11] 435898 0
Safety and Tolerability
Timepoint [11] 435898 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [12] 437341 0
Assessment of Attention & Working Memory
Timepoint [12] 437341 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [13] 437342 0
Assessment of Processing Speed
Timepoint [13] 437342 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [14] 437343 0
Assessment of Speed & Switching (Executive Function)
Timepoint [14] 437343 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [15] 437344 0
Assessment of pre-morbid cognitive & memory functioning
Timepoint [15] 437344 0
Baseline and week 4 post-randomisation.
Optional: week 8 post-randomisation.
Secondary outcome [16] 437345 0
Inflammatory factors
Timepoint [16] 437345 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [17] 437346 0
Growth factors
Timepoint [17] 437346 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [18] 437347 0
Astrocyte damage
Timepoint [18] 437347 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.
Secondary outcome [19] 437348 0
Biomarkers associated with PTSD
Timepoint [19] 437348 0
Baseline, weeks 1, 2, 3 and 4 post-randomisation.
Optional: weeks 5, 6, 7 and 8 post-randomisation.

Eligibility
Key inclusion criteria
Female participants aged between 18-70 years providing informed consent
Self-report history of IPV (> 3 months)
Have daily access to a smartphone and internet
Eligible for Medicare
Self-report history of IPV-BI meeting The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury
Persistent post-concussion symptoms as described by ICD-10 post-concussion syndrome via the Rivermead Post Concussion Symptom Questionnaire (RPQ)
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
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:
Prior diagnosis of, or currently taking medication for cardiovascular (e.g., beta-blockers), metabolic or pulmonary conditions;
Family history of myocardial infarction, coronary revascularisation or sudden death before 55 years;
Diagnosis of hypertension;
Diagnosis of hyperlipidemia;
Subjects with peripheral circulatory disorders.

History of prior head injury as defined by:
Any head injury within the last 30 days
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 months

No more than 2 mild symptoms on the Rivermead Post-Concussion Symptoms Questionnaire at the initial visit (i.e., asymptomatic).

Probable post-traumatic stress disorder (PTSD) as measured by Post traumatic Stress Disorder Checklist PCL-5.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women with IPV 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 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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/05/2024
Date of last participant enrolment
Anticipated
16/03/2027
Actual
Date of last data collection
Anticipated
16/05/2027
Actual
Sample size
Target
120
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26641 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42681 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 316668 0
Government body
Name [1] 316668 0
National Health and Medical Research Council
Country [1] 316668 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318853 0
None
Name [1] 318853 0
Address [1] 318853 0
Country [1] 318853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315446 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315446 0
Ethics committee country [1] 315446 0
Australia
Date submitted for ethics approval [1] 315446 0
17/10/2023
Approval date [1] 315446 0
14/11/2023
Ethics approval number [1] 315446 0
40295

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134726 0
Dr Georgia Fuller Symons
Address 134726 0
The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 134726 0
Australia
Phone 134726 0
+61 0434910441
Fax 134726 0
Email 134726 0
[email protected]
Contact person for public queries
Name 134727 0
Georgia Fuller Symons
Address 134727 0
The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 134727 0
Australia
Phone 134727 0
+61 0434910441
Fax 134727 0
Email 134727 0
[email protected]
Contact person for scientific queries
Name 134728 0
Georgia Fuller Symons
Address 134728 0
The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 134728 0
Australia
Phone 134728 0
+61 0434910441
Fax 134728 0
Email 134728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.