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NCT Number: NCT06804733

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Lihuili Hospital of Ningbo University

Ningbo, Zhejiang, 315040, China

Location status: Recruiting

Location contact

Dr. Zhou

CONTACT

[email protected]

18395804423

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: At baseline and the end of intervention at week 12

    Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET)

Secondary outcomes

  1. Crohn's Disease Activity Index (CDAI)

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

    Measurement of patient-reported disease activity of CD participants. Higher scores mean higher activity. <150 indicates remission, 150~219 indicates mildly active.

  2. Partial Mayo Score

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

    Measurement of Patient-reported disease activity of UC participants. Higher scores mean higher activity. 0~1 indicates remission. 2~4 indicates mildly active.

  3. Concentration of fecal calprotectin

    Time frame: At baseline and the end of intervention at week 12

  4. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: At baseline and the end of intervention at week 12

    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.

  5. Fatigue severity scale (FSS)

    Time frame: At baseline and the end of intervention at week 12

    Minimum value is 9 and maximum value is 63 with higher scores indicating higher level of fatigue.

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: At baseline and the end of intervention at week 12

    Score of 0~21 with higher scores indicates higher level of anxiety and depression

  7. International Physical Activity Questionnaire (IPAQ) short form

    Time frame: At baseline and the end of intervention at week 12

    A total IPAQ score is the sum of walking, moderate and vigorous metabolic equivalent of task (MET)-min/week.

  8. Body Mass Index (BMI) in kg/m^2

    Time frame: At baseline and the end of intervention at week 12

  9. Waist circumference in cm

    Time frame: At baseline and the end of intervention at week 12

  10. Concentration of serum fasting glucose in mmol/L

    Time frame: At baseline and the end of intervention at week 12

  11. Concentration of serum albumin in g/L

    Time frame: At baseline and the end of intervention at week 12

  12. Concentration of serum cholesterol in mmol/L

    Time frame: At baseline and the end of intervention at week 12

  13. Concentration of serum triglyceride in mmol/L

    Time frame: At baseline and the end of intervention at week 12

  14. Concentration of serum fasting lipoprotein in mmol/L

    Time frame: At baseline and the end of intervention at week 12

  15. Concentration of serum uric acid in mmol/L

    Time frame: At baseline and the end of intervention at week 12

  16. Oxygen uptake at aerobic threshold (in ml/kg/min)

    Time frame: at baseline and the end of intervention at week 12

    Oxygen uptake at aerobic threshold measured by CPET

  17. Peak oxygen uptake per heart rate (in ml/kg/min)

    Time frame: at baseline and the end of intervention at week 12

    Peak oxygen uptake per heart rate measured by CPET

  18. Maximal heart rate (in bpm)

    Time frame: At baseline and the end of intervention at week 12

    Maximal heart rate at peak measured by CPET

  19. Six-Minute Walk Test (in meters)

    Time frame: At baseline and the end of intervention at week 12

    Maximum walked distance in meters conducted according to guideline

  20. Exercise Benefits/Barriers Scale

    Time frame: At baseline and the end of intervention at week 12

    The Exercise Benefits/Barriers Scale (EBBS) will be used to assess participants' perceived benefits and barriers to exercise.

  21. Plasma C-reactive protein (mg/L)

    Time frame: At baseline and end of the intervention at week 12

  22. Plasma hemoglobin level (in g/L)

    Time frame: At baseline and end of the intervention at week 12

  23. Body fat percentage (%)

    Time frame: At baseline and end of the intervention at week 12

    Body fat percentage measured via body composition analysis

  24. Skeletal muscle mass (kg)

    Time frame: At baseline and end of the intervention at week 12

    Skeletal muscle mass (kg) measured via body composition analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhou, M.D.

CONTACT

[email protected]

8618395804423

Sponsors and collaborators

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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