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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
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Scientific title
Feasibility, Safety and Efficacy of Combined Aerobic and Resistance High-Intensity Interval Training for Adults with Disorders of Gut-Brain Interaction
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Secondary ID [1]
313569
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None
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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:
Functional constipation
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Irritable bowel syndrome
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Disorders of gut-brain interaction
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Functional dyspepsia
336085
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Condition category
Condition code
Oral and Gastrointestinal
332639
332639
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330163
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Behaviour
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Intervention code [2]
330164
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Treatment: Other
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Intervention code [3]
330162
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Assess the efficacy of 8-weeks of combined high-intensity exercise on mental health in people with disorders of gut-brain interaction.
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Assessment method [1]
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Hospital Anxiety and Depression Scale (HADS) scores.
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Timepoint [1]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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Primary outcome [2]
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Feasibility as a composite outcome of recruitment, adherence and retention rates of high-intensity interval training for people with disorders of gut-brain interaction.
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Assessment method [2]
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C-HIIT will be deemed feasible, if two of the following three criteria being met: >80% of those eligible agree to participate, >70% of participants adhere to the exercise prescription, >70% of participants complete post-intervention testing. This will be collected via enrolment records, exercise session sheets (completed at every session for every participant by the exercise physiologist or student), and post-control testing appointments.
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Timepoint [2]
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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))
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Primary outcome [3]
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Assess the safety of 8-weeks of combined high-intensity interval training for people with disorders of gut-brain interaction.
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Assessment method [3]
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C-HIIT will be deemed safe, if there are a similar number of serious adverse events between groups (intervention and usual care). During the intervention participants will be asked at every session if there have been any adverse events, and this will also be monitored during the session (this could include, nausea, bowel upsets or any injury.) This will be assessed via participant reporting, and if necessary, investigated by a doctor.
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Timepoint [3]
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Adverse events collected during weekly phone calls (usual care) and face-to-face exercise sessions (intervention).
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Secondary outcome [1]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on quality of life.
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Assessment method [1]
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36-item short form survey (SF-36)
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Timepoint [1]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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Secondary outcome [2]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on food intake.
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Assessment method [2]
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Composite dietary assessments are the Automated Self-Administered Dietary Assessment Tool (ASA24) and the Comprehensive Nutrition Assessment Questionnaire (CNAQ)
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Timepoint [2]
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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)
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Secondary outcome [3]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on inflammatory markers.
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Assessment method [3]
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Blood samples (12mL) will be collected at baseline and 8 weeks. Plasma and serum will be collected via centrifugation and stored at -80°C until analysis. Inflammatory cytokines (IL-5, IL-13, IL-2, IL-6, IL-9, IL-10, IFN-y, TNF-a, IL-17a, IL-17F, IL-4 and IL-22) will be assessed using the BioLegend LegendPLEX Th cytokine panel via a flow cytometer and C-reactive protein levels will be measured via enzyme linked immunosorbent assay.
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Timepoint [3]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [4]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on cardiorespiratory fitness.
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Assessment method [4]
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Maximal V02 using a graded exercise test.
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Timepoint [4]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [5]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on body composition.
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Assessment method [5]
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Dual-energy x-ray absorptiometry.
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Timepoint [5]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [6]
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Gastrointestinal symptoms
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Assessment method [6]
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Structured assessment of gastrointestinal symptoms (SAGIS)
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Timepoint [6]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1 -week of C-HIIT completion)
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Secondary outcome [7]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on gut microbiome function and composition.
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Assessment method [7]
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Participants will provide a stool sample at each time point (at home at their convenience) for microbiome analysis and fecal calprotectin testing.
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Timepoint [7]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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Secondary outcome [8]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on gastrointestinal symptoms.
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Assessment method [8]
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The irritable bowel syndrome- symptom severity score (IBS-SSS)
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Timepoint [8]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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Secondary outcome [9]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on blood pressure.
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Assessment method [9]
443783
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An automated sphygmomanometer.
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Timepoint [9]
443783
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [10]
443784
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Assess the efficacy of 8-weeks of combined high-intensity interval training on neuromuscular fitness.
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Assessment method [10]
443784
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A handgrip dynamometer will assess the peak handgrip strength
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Timepoint [10]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [11]
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Assess the efficacy of 8-weeks of combined high-intensity interval training on physical activity levels.
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Assessment method [11]
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International Physical Activity Questionnaire (IPAQ)
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Timepoint [11]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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Secondary outcome [12]
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Lower body function
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Assessment method [12]
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3o-seconds sit to stand
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Timepoint [12]
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Baseline, post-control (within 2 weeks of 8-week control period) and post C-HIIT (within 1-week of C-HIIT completion)
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Secondary outcome [13]
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Functional upper body strength
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Assessment method [13]
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30-second bicep curl
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Timepoint [13]
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Baseline, post-control (within 2 weeks of 8-week control period) and post-CHIIT (within 1-week of C-HIIT completion)
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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.
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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
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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
18/05/2023
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Date of last participant enrolment
Anticipated
25/04/2025
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
32
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
318031
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Other
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Name [1]
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Centre of Research Excellence Transforming Gut Health
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Address [1]
318031
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Country [1]
318031
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Australia
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Funding source category [2]
318051
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University
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Name [2]
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Higher degree by Research Training Scholarship, University of Newcastle
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Address [2]
318051
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Country [2]
318051
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Australia
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Funding source category [3]
318049
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University
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Name [3]
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School of Biomedical Sciences and Pharmacy, University of Newcastle
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Address [3]
318049
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Country [3]
318049
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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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]
320375
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Address [1]
320375
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Country [1]
320375
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
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human-ethics@newcastle.edu.au
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Ethics committee country [1]
316688
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Australia
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Date submitted for ethics approval [1]
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18/08/2022
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Approval date [1]
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25/08/2022
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Ethics approval number [1]
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H-2022-0269
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Summary
Brief summary
This will be a pilot trial assessing the feasibility, safety and efficacy of combined high-intensity interval training (C-HIIT) for people with disorders of gut-brain interaction (DGBI). Participants will be recruited from the local Newcastle and Hunter region district (NSW). After consent is provided, participants will undergo testing (including cardiopulmonary exercise testing, body composition, bloods, stool sample, functional strength and a series of questionnaires to capture mental health, gastrointestinal symptoms, overall wellbeing and dietary habits) and then be asked to maintain current dietary and physical activity habits for 8-weeks and then come in to repeat the testing in week 9. Following this, participants will undergo 8- weeks of 3 x weekly, 30-minute C-HIIT sessions, supervised by an accredited exercise physiologist or exercise science student. Participants will then repeat the same testing and will be invited to participate in an interview to better understand their experience with the program.
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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 Emily Cox
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Address
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 2 4985 4515
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jacinta Durney
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Address
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 404 205 197
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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
Name
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Jacinta Durney
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Address
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 404 205 197
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Fax
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Email
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[email protected]
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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.
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