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

Official title

Telemedicine-based Individualized Aerobic Exercise Training in Adults With Inactive or Mildly Active Inflammatory Bowel Disease: A Semi-crossover Randomized Controlled Trial

Overview

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. Does this aerobic training program improve the cardiopulmonary function of participants? 2. Does this aerobic training program help control disease activity? 3. Does this aerobic training program improve participants' quality of life? Researchers will divide participants into two groups. One group will participate in the training program directly. The other group will first undergo a 12-week control intervention (i.e., standard treatment) before proceeding to the training program. Participants will: 1. Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks. 2. Visit the clinic once every 4 weeks for check-ups and tests. 3. Keep a diary of symptoms.

Detailed description

This study is a single-center, semi-crossover, randomized controlled trial. Patients will be consecutively screened from gastroenterology and inflammatory bowel disease clinics. After obtaining informed consent, they are randomly assigned in a 1:1 ratio, stratified by diagnosis (CD and UC). Group A immediately begins a 12-week individualized exercise training program, while Group B starts with a 12-week control intervention, consisting only of routine diagnosis and treatment, followed by the 12-week individualized exercise training. Comparisons are made for all patients before and after the exercise training and the control intervention.

Participants will be given different progressive individualized aerobic training schedules based on their baseline physical activity levels, with the exercise intensity increased every 4 weeks.

The implementation of the training program is based on telemedicine, utilizing a combination of methods including wearable devices, WeChat groups, and online form submissions to ensure quality control over the duration, intensity, and quality of the exercise training. Participants are required to wear fitness bands during the exercise training and use exercise software to record the exercise process, including duration, trajectory, maximal heart rate, and average heart rate. These data are promptly sent to the researchers upon completion of the exercise. Before the commencement of the exercise program, a dedicated researcher instructs the participants on how to use the bands to record the type of exercise, duration, and maximum heart rate, and then to timely fill in the exercise records on the online forms. Additionally, the researchers will discuss with the participants at the outset about the individualized exercise (including location, frequency, intensity, and type), the participants' motivation, expectations, and goals, as well as potential difficulties, aiming to enhance adherence to the training program.

Interventions

• Behavioral 12-week individualized aerobic exercise training
  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.
• Behavioral 12-week control intervention followed by 12-week aerobic exercise training
  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.

Primary outcome measures

• Change in peak oxygen uptake (pVO2) (in ml/kg/min) [Time frame: At baseline and the end of intervention at week 12]

Secondary outcome measures (12)

• Crohn's Disease Activity Index (CDAI) [Time frame: At baseline, week 4, week 8 and the end of intervention at week 12]
• Partial Mayo Score [Time frame: At baseline, week 4, week 8 and the end of intervention at week 12]
• Concentration of fecal calprotectin [Time frame: At baseline and the end of intervention at week 12]
• Inflammatory Bowel Disease Questionnaire (IBDQ) [Time frame: At baseline and the end of intervention at week 12]
• Fatigue severity scale (FSS) [Time frame: At baseline and the end of intervention at week 12]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: At baseline and the end of intervention at week 12]
• International Physical Activity Questionnaire (IPAQ) short form [Time frame: At baseline and the end of intervention at week 12]
• Body Mass Index (BMI) in kg/m^2 [Time frame: At baseline and the end of intervention at week 12]
• Waist circumference in cm [Time frame: At baseline and the end of intervention at week 12]
• Concentration of serum fasting glucose in mmol/L [Time frame: At baseline and the end of intervention at week 12]
• Concentration of serum albumin in g/L [Time frame: At baseline and the end of intervention at week 12]
• Concentration of serum cholesterol in mmol/L [Time frame: At baseline and the end of intervention at week 12]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

China · 1 center

• the Affiliated Lihuili Hospital of Ningbo University — Ningbo

Publications

• 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

Identifiers

NCT: NCT06804733 · KY2024SL379-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗