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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
28
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.
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.
the Affiliated Lihuili Hospital of Ningbo University
Ningbo, Zhejiang, China
RECRUITINGChange 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
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
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
Concentration of fecal calprotectin
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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
Concentration of serum triglyceride in mmol/L
Time frame: At baseline and the end of intervention at week 12
Concentration of serum fasting lipoprotein in mmol/L
Time frame: At baseline and the end of intervention at week 12
Concentration of serum uric acid in mmol/L
Time frame: At baseline 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
Time frame: 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
Time frame: at baseline and the end of intervention at week 12
Maximal heart rate (in bpm)
Maximal heart rate at peak measured by CPET
Time frame: 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
Time frame: 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.
Time frame: At baseline and the end of intervention at week 12
Plasma C-reactive protein (mg/L)
Time frame: At baseline and end of the intervention at week 12
Plasma hemoglobin level (in g/L)
Time frame: At baseline and end of the intervention at week 12
Body fat percentage (%)
Body fat percentage measured via body composition analysis
Time frame: At baseline and end of the intervention at week 12
Skeletal muscle mass (kg)
Skeletal muscle mass (kg) measured via body composition analysis
Time frame: At baseline and end of the intervention at week 12
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