Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 5:31 PM
Study NCT ID:
NCT06804733
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease
Sponsor:
Ningbo Medical Center Lihuili Hospital
Organization:
Study Overview
Official Title:
Telemedicine-based Individualized Aerobic Exercise Training in Adults With Inactive or Mildly Active Inflammatory Bowel Disease: A Semi-crossover Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: