Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease

NCT06804733 | Recruiting

• 1 other identifier: KY2024SL379-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a 12-week individualized aerobic training program helps manage inactive or mildly active inflammatory bowel disease (IBD) including Crohn's disease (CD) and ulcerative colitis (UC) in adult patients aged 18-65 years. It will also assess participant compliance and the safety of the training program. The main questions it aims to answer are:

1. 1.Does this aerobic training program improve the cardiopulmonary function of participants?
2. 2.Does this aerobic training program help control disease activity?
3. 3.Does this aerobic training program improve participants' quality of life?
4. 4.Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks.
5. 5.Visit the clinic once every 4 weeks for check-ups and tests.
6. 6.Keep a diary of symptoms.

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen uptake (pVO2) (in ml/kg/min)

  Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET)

  At baseline and the end of intervention at week 12

Secondary Outcomes (24)

• Crohn's Disease Activity Index (CDAI)

  At baseline, week 4, week 8 and the end of intervention at week 12

• Partial Mayo Score

  At baseline, week 4, week 8 and the end of intervention at week 12

• Concentration of fecal calprotectin

  At baseline and the end of intervention at week 12

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  At baseline and the end of intervention at week 12

• Fatigue severity scale (FSS)

  At baseline and the end of intervention at week 12

Study Arms (2)

12-week control intervention followed by 12-week aerobic exercise training

ACTIVE COMPARATOR

Behavioral: 12-week control intervention followed by 12-week aerobic exercise training

12-week aerobic exercise training directly

EXPERIMENTAL

Behavioral: 12-week individualized aerobic exercise training

Interventions

12-week individualized aerobic exercise training BEHAVIORAL

After enrollment, subjects directly participate in a 12-week aerobic exercise training program. The training plan provides individualized progressive aerobic training based on their baseline physical activity level measured by International Physical Activity Questionnaire (IPAQ), with the exercise intensity being increased every four weeks.

12-week aerobic exercise training directly

12-week control intervention followed by 12-week aerobic exercise training BEHAVIORAL

After enrollment, subjects first undergo a 12-week control intervention (i.e., routine treatment) and then participate in a 12-week aerobic exercise training program. The training plan provides individualized progressive aerobic training based on their baseline physical activity level IPAQ, with the exercise intensity being increased every four weeks.

12-week control intervention followed by 12-week aerobic exercise training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

the Affiliated Lihuili Hospital of Ningbo University

Ningbo, Zhejiang, 315040, China

RECRUITING

Related Publications (1)

• Zhou Y, Liu H, Qian X, Zhang X, Xu F. Telemedicine-based individualised aerobic exercise training in Chinese adults with inactive or mildly active inflammatory bowel disease: study protocol for a single-centre, semi-crossover randomised controlled trial. BMJ Open. 2026 Jan 5;16(1):e103297. doi: 10.1136/bmjopen-2025-103297.

  PMID: 41490862 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Ying Zhou, M.D.

CONTACT

8618395804423; drzhouying07@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: February 3, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start Date: Upon publication of this clinical trial. End Date: Five years following publication.
• Access Criteria: Who can access the data? Researchers who provide a methodologically sound proposal. For what types of analysis? To achieve aims in the approved proposal. How can they access it? Proposals should be directed to drzhouying07@126.com. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)