Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000111471
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
31/01/2025
Date last updated
31/01/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined High-Intensity Interval Training for Adults with Disorders of Gut-Brain Interaction
Scientific title
Feasibility, Safety and Efficacy of Combined Aerobic and Resistance High-Intensity Interval Training for Adults with Disorders of Gut-Brain Interaction
Secondary ID [1] 313569 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional constipation 336086 0
Irritable bowel syndrome 336084 0
Disorders of gut-brain interaction 336083 0
Functional dyspepsia 336085 0
Condition category
Condition code
Oral and Gastrointestinal 332639 332639 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will exercise (supervised by an accredited exercise physiologist or exercise scientist student) for 26 minutes three times per week, for an exercise duration of 78 minutes/week, over the course of 8 weeks. Sessions will be either one on one, or in a small group, depending on time and day preference, and or participant requests. Each session will begin with an aerobic warm-up for three minutes at 50-60% heart rate peak (HRpeak) (determined from the peak heart rate achieved during the cardiopulmonary exercise test) before completing four minutes of high-intensity aerobic exercise at 85-95% of HRpeak. The goal is to reach the target zone within the first two minutes. Following one minute of rest, participants will complete 8 x 1-minute intervals of high-intensity resistance exercise at a rate of perceived exertion (RPE) of greater than or equal to 8 (very hard). This will be monitored throughout, and an RPE of 7 will incur that the weights for that exercise need to be increased. Exercises include functional exercises such as squats, push-ups and lunges that can be adapted to different levels of strength and ability. Participants will complete as many repetitions (at least five; aiming for 10-25) as possible within each 1-minute bout while maintaining correct form. One minute of rest will separate each interval. The session will end with an aerobic cool-down for three minutes at 50-60% of HRpeak. Each completed session will be marked off as attended and the RPE average will be calculated to assess adherence.
Intervention code [1] 330163 0
Behaviour
Intervention code [2] 330164 0
Treatment: Other
Intervention code [3] 330162 0
Lifestyle
Comparator / control treatment
Usual care. Participants undertake an 8-week control period where they are asked to not change any of their current exercise or dietary habits.
Control group
Active

Outcomes
Primary outcome [1] 340177 0
Assess the efficacy of 8-weeks of combined high-intensity exercise on mental health in people with disorders of gut-brain interaction.
Timepoint [1] 340177 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
Primary outcome [2] 340175 0
Feasibility as a composite outcome of recruitment, adherence and retention rates of high-intensity interval training for people with disorders of gut-brain interaction.
Timepoint [2] 340175 0
Baseline (assessing recruitment rates), post-control (follow up) within 2-weeks of 8-week control period)) and post-CHIIT (adherence) within 1-week of C-HIIT completion))
Primary outcome [3] 340176 0
Assess the safety of 8-weeks of combined high-intensity interval training for people with disorders of gut-brain interaction.
Timepoint [3] 340176 0
Adverse events collected during weekly phone calls (usual care) and face-to-face exercise sessions (intervention).
Secondary outcome [1] 443175 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on quality of life.
Timepoint [1] 443175 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
Secondary outcome [2] 443790 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on food intake.
Timepoint [2] 443790 0
ASA24: Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion) (ASA24) CNAQ: Baseline and post-CHIIT (within 1-week of C-HIIT completion)
Secondary outcome [3] 443781 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on inflammatory markers.
Timepoint [3] 443781 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [4] 443782 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on cardiorespiratory fitness.
Timepoint [4] 443782 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [5] 443785 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on body composition.
Timepoint [5] 443785 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [6] 444438 0
Gastrointestinal symptoms
Timepoint [6] 444438 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1 -week of C-HIIT completion)
Secondary outcome [7] 443780 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on gut microbiome function and composition.
Timepoint [7] 443780 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
Secondary outcome [8] 443779 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on gastrointestinal symptoms.
Timepoint [8] 443779 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
Secondary outcome [9] 443783 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on blood pressure.
Timepoint [9] 443783 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [10] 443784 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on neuromuscular fitness.
Timepoint [10] 443784 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [11] 443787 0
Assess the efficacy of 8-weeks of combined high-intensity interval training on physical activity levels.
Timepoint [11] 443787 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
Secondary outcome [12] 444280 0
Lower body function
Timepoint [12] 444280 0
Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
Secondary outcome [13] 444281 0
Functional upper body strength
Timepoint [13] 444281 0
Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)

Eligibility
Key inclusion criteria
Participants will be individuals aged 18 years and over with a diagnosed disorder of gut-brain interaction (DGBI) such as irritable bowel syndrome (IBS) or functional dyspepsia (FD). DGBI diagnosis may be confirmed using the Rome IV criteria, which includes recurrent abdominal pain on average at least one day per week in the last three months, associated with two or more of the following: 1) related to defecation, 2) associated with a change in frequency of stool, 3) associated with a change in form (appearance) of stool. Decisions on inclusion will be made in collaboration with the study Doctor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be ineligible if they: have an organic gastrointestinal disorder (e.g., inflammatory bowel disease, colorectal cancer or coeliac disease), are experiencing ‘alarm’ signs or symptoms (e.g., gastrointestinal bleeding, iron deficiency anaemia, significant unexplained weight loss), have any condition as per the absolute contraindications to exercise outlined by the American College of Sports Medicine (ACSM, 2021) including, but not limited to: unstable angina; recent (within the past four weeks) myocardial infarction; coronary artery disease; uncompensated heart failure; New York Heart Association functional classification II-IV; severe valvular illness; pulmonary disease; uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg); renal failure (chronic kidney disease stages IV-V); cardiomyopathy. People will also be ineligible for: meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), due to planned medical operations during the research period, a physical condition whereby exercise training would be inappropriate, pregnant or expecting to be pregnant during the study period, and non-English speaking.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/2023
Date of last participant enrolment
Anticipated
25/04/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
32
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318031 0
Other
Name [1] 318031 0
Centre of Research Excellence Transforming Gut Health
Country [1] 318031 0
Australia
Funding source category [2] 318051 0
University
Name [2] 318051 0
Higher degree by Research Training Scholarship, University of Newcastle
Country [2] 318051 0
Australia
Funding source category [3] 318049 0
University
Name [3] 318049 0
School of Biomedical Sciences and Pharmacy, University of Newcastle
Country [3] 318049 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 320375 0
None
Name [1] 320375 0
Address [1] 320375 0
Country [1] 320375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316688 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 316688 0
Ethics committee country [1] 316688 0
Australia
Date submitted for ethics approval [1] 316688 0
18/08/2022
Approval date [1] 316688 0
25/08/2022
Ethics approval number [1] 316688 0
H-2022-0269

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

Contacts
Principal investigator
Name 138674 0
Dr Emily Cox
Address 138674 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 138674 0
Australia
Phone 138674 0
+61 2 4985 4515
Fax 138674 0
Email 138674 0
[email protected]
Contact person for public queries
Name 138675 0
Jacinta Durney
Address 138675 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 138675 0
Australia
Phone 138675 0
+61 404 205 197
Fax 138675 0
Email 138675 0
[email protected]
Contact person for scientific queries
Name 138676 0
Jacinta Durney
Address 138676 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 138676 0
Australia
Phone 138676 0
+61 404 205 197
Fax 138676 0
Email 138676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.