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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
Secondary ID [1] 0 0
LTU HIIT in ILD
Universal Trial Number (UTN)
Trial acronym
HIIT in fILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrotic Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in endurance time
Timepoint [1] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [1] 0 0
Change in dyspnea measured using the Dyspnea-12 questionnaire
Timepoint [1] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [2] 0 0
Changes in fatigue evaluated by the Fatigue Severity Scale
Timepoint [2] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [3] 0 0
Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
Timepoint [3] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [4] 0 0
Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
Timepoint [4] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [5] 0 0
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Timepoint [5] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [6] 0 0
Change in functional exercise capacity assessed by 6-minute walk distance
Timepoint [6] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [7] 0 0
Changes in skeletal muscle size
Timepoint [7] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [8] 0 0
Dyspnea related disability - measured with modified medical research council scale (MMRC)
Timepoint [8] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [9] 0 0
Global rating of change
Timepoint [9] 0 0
Baseline, nine weeks and 6 months following intervention
Secondary outcome [10] 0 0
Change in physical activity
Timepoint [10] 0 0
Baseline, nine weeks and 6 months following intervention

Eligibility
Key inclusion criteria
* Diagnosis of fibrotic interstitial lung disease (fILD)
* Able to read and speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Anne Holland
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Holland
Address 0 0
Country 0 0
Phone 0 0
+61 3 99030214
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03800914