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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03800914
Registration number
NCT03800914
Ethics application status
Date submitted
9/01/2019
Date registered
11/01/2019
Date last updated
19/10/2023
Titles & IDs
Public title
High Intensity Interval Training in Fibrotic Interstitial Lung Disease
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Scientific title
High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
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Secondary ID [1]
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LTU HIIT in ILD
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Universal Trial Number (UTN)
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Trial acronym
HIIT in fILD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fibrotic Interstitial Lung Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - High intensity interval training
Other interventions - Traditional pulmonary rehabilitation
Experimental: High Intensity Interval Training - Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training.
Active Comparator: Traditional pulmonary rehabilitation - Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training.
Other interventions: High intensity interval training
36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling
Other interventions: Traditional pulmonary rehabilitation
30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in endurance time
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Assessment method [1]
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Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
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Timepoint [1]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [1]
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Change in dyspnea measured using the Dyspnea-12 questionnaire
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Assessment method [1]
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Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.
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Timepoint [1]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [2]
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Changes in fatigue evaluated by the Fatigue Severity Scale
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Assessment method [2]
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Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.
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Timepoint [2]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [3]
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Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
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Assessment method [3]
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The SGRQ-I is a disease specific HRQoL measure with similar psychometric properties to the original SGRQ that is designed to be more relevant in patients with IPF. The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.
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Timepoint [3]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [4]
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Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
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Assessment method [4]
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The CRQ consists of 20 items across 4 domains: Dyspnea (activities that cause breathlessness and are performed frequently), fatigue, emotional function and mastery ( the patient's feeling of control over their disease). Each domain includes four to seven items, and each item is scored on a 7-point Likert score. Total scores for each domain range from 4-35. Values of each domain will be reported. Lower scores indicate more limitations in quality of life.
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Timepoint [4]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [5]
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Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
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Assessment method [5]
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Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.
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Timepoint [5]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [6]
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Change in functional exercise capacity assessed by 6-minute walk distance
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Assessment method [6]
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Distance in meters achieved on a 6-minute walk test
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Timepoint [6]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [7]
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Changes in skeletal muscle size
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Assessment method [7]
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Change in cross-sectional area of the Quadriceps will be measured by B-mode ultrasonography
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Timepoint [7]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [8]
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Dyspnea related disability - measured with modified medical research council scale (MMRC)
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Assessment method [8]
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The MMRC rates dyspnea according to different levels activity on a 5-point scale (grade 0-4), with grade 4 representing the greatest level of dyspnea impairment.
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Timepoint [8]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [9]
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Global rating of change
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Assessment method [9]
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The global rating of change will assess the participants' overall self-perceived change in health by asking the participant to rate their change as either 'worse', 'about the same' or 'better'. The extent of change ( (i.e., worsening or improvement) is then graded on a Likert scale from one to seven.
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Timepoint [9]
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Baseline, nine weeks and 6 months following intervention
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Secondary outcome [10]
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Change in physical activity
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Assessment method [10]
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Time spent sedentary and in physical activity of various intensities will be measured by a wrist-worn, tri-axial accelerometer.
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Timepoint [10]
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Baseline, nine weeks and 6 months following intervention
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Eligibility
Key inclusion criteria
- Diagnosis of fibrotic interstitial lung disease (fILD)
- Able to read and speak English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Resting oxygen saturation (SpO2) is < 85%
- Severe pulmonary hypertension (WHO class IV)
- Attendance at Pulmonary rehabilitation (PR) within last 12 months
- Comorbidities which preclude exercise training
- History of syncope on exertion
- Significant cognitive impairment
- Anticipated transplant or death within the duration of the study period
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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Prince Charles Hospital - Brisbane
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Recruitment hospital [4]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung
conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and
significant physical impairment. Exercise training is recommended for people with fILD in
improving breathlessness and exercise tolerance. However, despite the best efforts of
patients and clinicians, many of those who participate are not attaining its benefits. The
current exercise training strategies of moderate intensity continuous training may not be
well suited to fILD. High intensity interval training (HIIT), short bouts of high-intensity
exercise regularly interspersed with periods of rest or light exercise may be an alternate
exercise training option for people with fILD.
The study will determine to whether HIIT is better than the current method of continuous
exercise training at moderate intensity in improving exercise tolerance, breathlessness and
quality of life in people with fILD. A randomised controlled, assessor blinded trial will be
conducted. A total 130 people with fILD will be randomly assigned to moderate intensity
continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will
provide an exercise training strategy that can readily be implemented in practice that will
maximise the outcomes of exercise training for people with fILD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03800914
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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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Anne Holland
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anne Holland
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Address
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Country
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Phone
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+61 3 99030214
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03800914
Download to PDF