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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease (IBD)
• Intervention / Treatment: Behavioral: 12-week control intervention followed by 12-week aerobic exercise training; Behavioral: 12-week individualized aerobic exercise training

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Zhou, M.D.; Phone Number: 8618395804423; Email: drzhouying07@126.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315040
      • Recruiting
      • the Affiliated Lihuili Hospital of Ningbo University
      • Contact: Dr. Zhou; Phone Number: 18395804423; Email: drzhouying07@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 12-week control intervention followed by 12-week aerobic exercise training	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.
Experimental: 12-week aerobic exercise training directly	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's Disease Activity Index (CDAI)	Measurement of patient-reported disease activity of CD participants. Higher scores mean higher activity. <150 indicates remission, 150~219 indicates mildly active.	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)	32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scores range from 1 (poorest QoL) to 7 (best QoL). Higher scores indicate better QoL.	At baseline and the end of intervention at week 12
Fatigue severity scale (FSS)	Minimum value is 9 and maximum value is 63 with higher scores indicating higher level of fatigue.	At baseline and the end of intervention at week 12
Hospital Anxiety and Depression Scale (HADS)	Score of 0~21 with higher scores indicates higher level of anxiety and depression	At baseline and the end of intervention at week 12
International Physical Activity Questionnaire (IPAQ) short form	A total IPAQ score is the sum of walking, moderate and vigorous metabolic equivalent of task (MET)-min/week.	At baseline and the end of intervention at week 12
Body Mass Index (BMI) in kg/m^2		At baseline and the end of intervention at week 12
Waist circumference in cm		At baseline and the end of intervention at week 12
Concentration of serum fasting glucose in mmol/L		At baseline and the end of intervention at week 12
Concentration of serum albumin in g/L		At baseline and the end of intervention at week 12
Concentration of serum cholesterol in mmol/L		At baseline and the end of intervention at week 12
Concentration of serum triglyceride in mmol/L		At baseline and the end of intervention at week 12
Concentration of serum fasting lipoprotein in mmol/L		At baseline and the end of intervention at week 12
Concentration of serum uric acid in mmol/L		At baseline and the end of intervention at week 12
Partial Mayo Score	Measurement of Patient-reported disease activity of UC participants. Higher scores mean higher activity. 0~1 indicates remission. 2~4 indicates mildly active.	At baseline, week 4, week 8 and the end of intervention at week 12
Oxygen uptake at aerobic threshold (in ml/kg/min)	Oxygen uptake at aerobic threshold measured by CPET	at baseline and the end of intervention at week 12
Peak oxygen uptake per heart rate (in ml/kg/min)	Peak oxygen uptake per heart rate measured by CPET	at baseline and the end of intervention at week 12
Maximal heart rate (in bpm)	Maximal heart rate at peak measured by CPET	At baseline and the end of intervention at week 12
Six-Minute Walk Test (in meters)	Maximum walked distance in meters conducted according to guideline	At baseline and the end of intervention at week 12
Exercise Benefits/Barriers Scale	The Exercise Benefits/Barriers Scale (EBBS) will be used to assess participants' perceived benefits and barriers to exercise.	At baseline and the end of intervention at week 12
Plasma C-reactive protein (mg/L)		At baseline and end of the intervention at week 12
Plasma hemoglobin level (in g/L)		At baseline and end of the intervention at week 12
Body fat percentage (%)	Body fat percentage measured via body composition analysis	At baseline and end of the intervention at week 12
Skeletal muscle mass (kg)	Skeletal muscle mass (kg) measured via body composition analysis	At baseline and end of the intervention at week 12

Collaborators and Investigators

• Sponsor: Ningbo Medical Center Lihuili Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: KY2024SL379-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial will be shared.
• IPD Sharing Time Frame: Start Date: Upon publication of this clinical trial. End Date: Five years following publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No