None listed
Conditions
Brief summary
PRE-BIOTIC will be the world’s first randomised controlled trial (RCT) of anabolic exercise (high intensity PRT) for patients with active inflammatory bowel disease (IBD) who remain symptomatic despite robust medical treatment. Although current treatment is effective in controlling a number of their symptoms, there is a need for better options to prevent disease, increase response and sustain remission. Exercise is one potential complementary strategy to combat IBD and other diseases, and there is rapidly growing evidence that it may also positively and substantially affect the gut biome, and thus could play a role in both prevention and treatment of IBD. Among exercise modalities, the rationale for resistance training (PRT) in IBD is extremely strong, as it has many of the same benefits of aerobic exercise with regards to cardio-metabolic profile and inflammation, but in addition, due to its anabolic nature, provides unique benefits not seen with aerobic exercise, including increases in muscle strength and mass, bone density and appetite. An anabolic/anti-inflammatory intervention such as PRT is theoretically able to change the underlying pathophysiology of this condition, in addition to addressing important physical and psychological symptoms. The global impact and relief of suffering for these individuals and their loved ones would be unprecedented.
Interventions
The experimental group will undergo fully-supervised high intensity PRT 3 days/week for 16 weeks in a small group setting at the University of Sydney Clinic in Lidcombe. One day of rest will be provided between training days. Nine resistance exercises will be performed on Keiser pneumatic resistance machines including chest press, seated row, triceps push down, lat pull-down, leg press, leg extension, leg flexion, hip abduction and hip extension. Participants will be required to perform 3 sets
The experimental group will undergo fully-supervised high intensity PRT 3 days/week for 16 weeks in a small group setting at the University of Sydney Clinic in Lidcombe. One day of rest will be provided between training days. Nine resistance exercises will be performed on Keiser pneumatic resistance machines including chest press, seated row, triceps push down, lat pull-down, leg press, leg extension, leg flexion, hip abduction and hip extension. Participants will be required to perform 3 sets of 8 repetitions @ 80% one-repetition maximum (1RM) for each exercise. Cadence of repetitions will be performed explosively (as rapidly as possible) on the concentric phase and 3 seconds on the eccentric phase. Participants will have 90-second rest between sets. All training sessions over the 16 weeks will be supervised by accredited exercise physiologist (AEP) trainers in a ratio of 1 trainer: 1-4 participants. Participants will be progressed continuously throughout the 16-week intervention by approximately 3% per session, guided and refined by daily ratings of perceived exertion (with a target of 15-18 on the Borg Scale, which approximates 80% of the current peak strength). These ratings will reported by both the trainer (objective assessment) and the trainee (subjective assessment) for each machine when the load is initially presented on each day. In addition, one-repetition maximum (1RM) strength testing will be conducted in lieu of one of the 3 planned sets of exercise every 2 weeks, to maintain training intensity at 80% 1RM. Alterations needed to accommodate musculoskeletal pain or underlying injuries or other health conditions will be prescribed as needed by the AEPs and study physician, Professor Fiatarone Singh. Participants will be asked not to start any other new exercise regimen or intentionally change their habitual diet throughout the entire study and assessment and detraining period. All of the documentation of changes in health care, habitual exercise or diet noted for the control group below will also be recorded in the intervention group.Also, after 16 weeks, participants will be asked to refrain from resistance training for 6 weeks (from 17-22 weeks) to examine whether absence of resistance training over a short period has any effects on changes in disease activity and gut dysbiosis.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ulcerative Colitis (UC) or Crohn’s Disease (CD) of 3 months or greater duration. 2. Inactive to moderately active disease state based on scores from the Total Mayo Scoring Index for UC (scores of 0 to 10) and Crohn’s Disease Activity Index (CDAI) for CD (scores of 0 to 450). This change was made prior to any enrolments.
Exclusion criteria
1. Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine . 2. Planned major surgery within the first 3 months after randomisation. 3. Clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing and exercise intervention planned 4. Pregnant 5. Female planning pregnancy within the first 4 months after randomisation. 6. Participating in moderate aerobic training equal or greater than 150 minutes per week or vigorous aerobic training equal or greater than 75 minutes per week, or high intensity interval training 7. Those currently practicing resistance training, of any intensity equal or greater than one day per week 8. Participation in another clinical trial for which concurrent participation is deemed inappropriate Participants will be ineligible for the investigation of gut microbiota changes (therefore not required to give stool samples) if they have the following due to the influence on altering the gut microbiome: 1. Prior or concomitant/planned fecal microbiota transplantation or any rectal preparations for IBD currently 2. Probiotics during the study period or in the preceding 12 weeks 3. Significant prior gastrointestinal surgery (e.g., colon resection, fistula repair, bariatric surgery)
Outcome results
None listed