Inflammatory Bowel Disease (IBD)NCT06804733
Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease
A study testing 12-week individualized aerobic exercise training in people with Inflammatory Bowel Disease (IBD), run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- 12-week individualized aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Affiliated Lihuili Hospital of Ningbo University
Ningbo, Zhejiang, 315040
Dr. Zhou, 18395804423, drzhouying07@126.com
About this study
Official title: 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:
- Does this aerobic training program improve the cardiopulmonary function of participants?
- Does this aerobic training program help control disease activity?
- Does this aerobic training program improve participants' quality of life?
Read more
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:
- Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks.
- Visit the clinic once every 4 weeks for check-ups and tests.
- Keep a diary of symptoms.
Read the 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.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- 12-week individualized aerobic exercise training, 12-week control intervention followed by 12-week aerobic exercise training
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week individualized aerobic exercise trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-week control intervention followed by 12-week aerobic exercise training | Active comparator | Not described Receives: Behavioral: 12-week control intervention followed by 12-week aerobic exercise training |
| 12-week aerobic exercise training directly | Experimental | Not described Receives: Behavioral: 12-week individualized aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake (pVO2) (in ml/kg/min)
Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET)
Measured: At baseline and the end of intervention at week 12
Secondary outcomes (24)
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.
Measured: 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.
Measured: At baseline, week 4, week 8 and the end of intervention at week 12
Concentration of fecal calprotectin
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At baseline and the end of intervention at week 12
Body Mass Index (BMI) in kg/m^2
Measured: At baseline and the end of intervention at week 12
Waist circumference in cm
Measured: At baseline and the end of intervention at week 12
Concentration of serum fasting glucose in mmol/L
Measured: At baseline and the end of intervention at week 12
Concentration of serum albumin in g/L
Measured: At baseline and the end of intervention at week 12
Concentration of serum cholesterol in mmol/L
Measured: At baseline and the end of intervention at week 12
Concentration of serum triglyceride in mmol/L
Measured: At baseline and the end of intervention at week 12
Concentration of serum fasting lipoprotein in mmol/L
Measured: At baseline and the end of intervention at week 12
Concentration of serum uric acid in mmol/L
Measured: 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
Measured: 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
Measured: at baseline and the end of intervention at week 12
Maximal heart rate (in bpm)
Maximal heart rate at peak measured by CPET
Measured: 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
Measured: 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.
Measured: At baseline and the end of intervention at week 12
Plasma C-reactive protein (mg/L)
Measured: At baseline and end of the intervention at week 12
Plasma hemoglobin level (in g/L)
Measured: At baseline and end of the intervention at week 12
Body fat percentage (%)
Body fat percentage measured via body composition analysis
Measured: At baseline and end of the intervention at week 12
Skeletal muscle mass (kg)
Skeletal muscle mass (kg) measured via body composition analysis
Measured: At baseline and end of the intervention at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804733
- Sponsor's protocol ID
- KY2024SL379-01
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial will be shared.
Publications
Zhou Y, Liu H, Qian X, Zhang X, Xu F. Telemedicine-based individualised aerobic exercise training in Chinese adults with inactive or mildly active inflammatory bowel disease: study protocol for a single-centre, semi-crossover randomised controlled trial. BMJ Open. 2026 Jan 5;16(1):e103297. doi: 10.1136/bmjopen-2025-103297.
PubMed 41490862
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine-based Individualized Aerobic Exercise Training in Adults With Inactive or Mildly Active Inflammatory Bowel Disease: A Semi-crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06804733
- Acronym / sponsor ID
- KY2024SL379-01
- Conditions
- Inflammatory Bowel Disease (IBD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does this aerobic training program improve the cardiopulmonary function of participants?
- Does this aerobic training program help control disease activity?
- 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:
- Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks.
- Visit the clinic once every 4 weeks for check-ups and tests.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week control intervention followed by 12-week aerobic exercise training | Active comparator | Behavioral: 12-week control intervention followed by 12-week aerobic exercise training |
| 12-week aerobic exercise training directly | Experimental | Behavioral: 12-week individualized aerobic exercise training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week individualized aerobic exercise trainingAfter 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. | Behavioural | 12-week aerobic exercise training directly |
| 12-week control intervention followed by 12-week aerobic exercise trainingAfter 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. | Behavioural | 12-week control intervention followed by 12-week aerobic exercise training |
Primary outcome
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)
24 secondary outcomes
Crohn's Disease Activity Index (CDAI)
Time frame: At baseline, week 4, week 8 and the end of intervention at week 12
Partial Mayo Score
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)
Time frame: At baseline and the end of intervention at week 12
Fatigue severity scale (FSS)
Time frame: At baseline and the end of intervention at week 12
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline and the end of intervention at week 12
International Physical Activity Questionnaire (IPAQ) short form
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)
Time frame: at baseline and the end of intervention at week 12
Peak oxygen uptake per heart rate (in ml/kg/min)
Time frame: at baseline and the end of intervention at week 12
Maximal heart rate (in bpm)
Time frame: At baseline and the end of intervention at week 12
Six-Minute Walk Test (in meters)
Time frame: At baseline and the end of intervention at week 12
Exercise Benefits/Barriers Scale
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 (%)
Time frame: At baseline and end of the intervention at week 12
Skeletal muscle mass (kg)
Time frame: At baseline and end of the intervention at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41490862Zhou Y, Liu H, Qian X, Zhang X, Xu F. Telemedicine-based individualised aerobic exercise training in Chinese adults with inactive or mildly active inflammatory bowel disease: study protocol for a single-centre, semi-crossover randomised controlled trial. BMJ Open. 2026 Jan 5;16(1):e103297. doi: 10.1136/bmjopen-2025-103297.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week individualized aerobic exercise training in people with Inflammatory Bowel Disease (IBD), run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, M.D. (8618395804423, drzhouying07@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (pVO2) (in ml/kg/min) (time frame: At baseline and the end of intervention at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.