12-week personalized aerobic program for adults with inactive or mildly active IBD
Telemedicine-based Individualized Aerobic Exercise Training in Adults With Inactive or Mildly Active Inflammatory Bowel Disease: A Semi-crossover Randomized Controlled Trial
This study will test whether a 12-week individualized aerobic exercise program helps adults (18–65) with inactive or mildly active Crohn's disease or ulcerative colitis improve fitness, control disease activity, and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ningbo Medical Center Lihuili Hospital Government |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06804733 on ClinicalTrials.gov |
What this trial studies
This single-center, semi-crossover randomized trial enrolls adults with remission or mildly active IBD and low baseline physical activity, randomly assigning them 1:1 by diagnosis to either immediate 12-week individualized aerobic training or 12 weeks of usual care followed by the same 12-week training. Exercise prescriptions are progressive and tailored to baseline activity, with intensity increased every four weeks. The program is delivered and monitored via telemedicine tools including wearable fitness bands, smartphone software, WeChat groups, and online reporting to track duration, trajectory, and heart rate. Primary outcomes include changes in cardiopulmonary function, disease activity, quality of life, adherence, and safety before and after the exercise intervention.
Who should consider this trial
Good fit: Adults aged 18–65 with a diagnosis of Crohn's disease or ulcerative colitis for >3 months who are in remission or have mildly active disease, have low baseline physical activity, and are willing to use wearables and telemedicine for a 12-week exercise program are ideal candidates.
Not a fit: People with moderate to severe active IBD, recent intestinal surgery, an ileostomy, pregnancy, or other conditions that limit safe physical activity are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could offer a safe, non-drug way to improve cardiorespiratory fitness, help maintain disease control, and enhance quality of life for people with inactive or mildly active IBD.
How similar studies have performed: Smaller studies and observational data have suggested that exercise can safely improve fitness and quality of life in IBD, but randomized, individualized aerobic programs of this type remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with CD or UC for more than 3 months. * Disease activity in remission or mildly active (CD: CDAI \< 220; UC: pMS \< 5). * Baseline physical activity intensity is low, measured by the IPAQ Chinese version short form, and without a habit of "regular exercise". * Agree to participate in the study and accept a 12-week individualized aerobic exercise training program. Exclusion Criteria: * Pregnant or breastfeeding, or planning to become pregnant within the next 3 months. * Presence of physical movement disorders or other chronic diseases that limit physical activity. * Having an ileostomy. * History of anal or intestinal surgery within the past 3 months.
Where this trial is running
Ningbo, Zhejiang
- the Affiliated Lihuili Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ying Zhou, M.D.
- Email: drzhouying07@126.com
- Phone: 8618395804423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.