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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNingbo Medical Center Lihuili Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: 12-week control intervention followed by 12-week aerobic exercise trainingActive comparator 1 intervention
Group B: 12-week aerobic exercise training directlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET)

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

Secondary outcomes

1

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.

Time frame
At baseline, week 4, week 8 and the end of intervention at week 12
2

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.

Time frame
At baseline, week 4, week 8 and the end of intervention at week 12
3

Concentration of fecal calprotectin

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

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.

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

Other outcomes

Sponsors and contacts

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