Inflammatory Bowel DiseasesNCT06427135
A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD
A study testing Exercise interventions in people with Inflammatory Bowel Diseases, run by Ping An.
Trial summary
This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Exercise interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Commitment to comply with the study procedures and cooperate in the implementation of the full study
- Age ≥ 18 years old, gender is not limited
- Muscle strength examination of all four limbs is greater than or equal to grade 3
- Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission
- Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety
- Voluntarily sign a written informed consent
Who cannot join
- Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control
- Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc
- Persons with unstable vital signs
- Presence of cognitive, communication disorders
- Patients who have recently undergone gastrointestinal surgery (<1 month) or who have not fully healed
- Short bowel syndrome
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- Presence of extra-intestinal manifestations and complications that interfere with therapy, such as retinopathy, deep vein thrombosis, etc
- Pregnant or lactating women
- Active tuberculosis; if subjects are suspected of having active tuberculosis, chest X-ray, sputum and exclusion by clinical signs and symptoms are required
- Other potential subjects who are not suitable for participation in this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in Inflammatory Bowel Disease: a Single-center, Randomized Controlled Trial
This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory bowel disease that mainly involves the digestive system, including Crohn's disease (CD) and ulcerative colitis (UC).CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation and intestinal obstruction. CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation, and intestinal obstruction; UC is characterized by diarrhea, mucopurulent blood stools, and abdominal pain, and the peak age of onset is between 15 and 40 years old. Notably, many studies have shown that patients with inflammatory bowel disease commonly suffer from malnutrition, low body mass index (BMI), muscle atrophy, decreased bone density, and fatigue and anxiety, and that surgery is not a one-time event, with patients often requiring several surgeries.
Current treatment strategies focus on medication, nutritional support and nursing care, neglecting other possible adjunctive treatments.
Exercise interventions, as an effective adjunctive therapy for inflammatory bowel disease, have been shown to have anti-inflammatory, anti-muscle atrophic, and physical enhancement effects, improve psychological status, and also have beneficial effects on intestinal flora and intestinal absorption. Exercise is also economical, efficient and highly feasible, making it more acceptable to IBD patients. With the integration of physical medicine and the implementation of Healthy China, the role of exercise intervention in the majority of patients will be more important and its application will be more extensive.
Multimodal wearable device is a simple and efficient miniaturized smart device commonly used in the field of exercise, which can monitor the wearer's heart rate, blood oxygen, step count, exercise data in real time, etc. This group proposes to combine the multimodal wearable device as an auxiliary device with the exercise intervention for patients with inflammatory bowel disease (IBD), which is the first of its kind in China.
Most of the current studies are conducted on the conditions of small samples, single period, and single exercise modality, lack of studies on large samples and multi index evaluation, and the field has not yet formed a unified consensus on personalized exercise intervention for different levels of patients. There is still considerable work to be done on the study of exercise interventions for the treatment of inflammatory bowel disease.
Therefore, this group proposes to conduct a randomized controlled trial to investigate the effects of exercise intervention on body composition and disease progression in patients with inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Exercise interventions
- Keywords
- Exercise interventions, Inflammatory Bowel Diseases, Wearable Device
- 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.
Exercise interventionsBehavioural
Rehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exercise interventions | Experimental | Adding exercise intervention therapy to existing medications Receives: Behavioral: Exercise interventions |
| Conventional drug therapy | No intervention | No exercise intervention, use of existing medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle mass index
Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P < 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m^2.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
Secondary outcomes (8)
Quality of life rating
Changes before and after the intervention were assessed by means of a quality of life questionnaire (Inflammatory Bowel Disease Questionnaire, IBDQ) with a total score of 224, the higher the better.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
Psychological assessment
Changes before and after the intervention were assessed by means of the Anxiety and Depression Scale (Hospital Anxiety and Depression Scale, HADS), with a total HADS score of 42, with higher scores indicating worse indicators.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
Fatigue status assessment
Changes before and after the intervention were assessed by means of a fatigue scale (Functional Assessment of Chronic Illness Therapy, FACIT), with a total FACIT score of 52, with a higher score indicating a better indicator.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
body fat percentage
Detecting changes in subjects' body fat percentage using a body composition analyzer
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
muscle power
Changes in muscle strength (kg) in the limbs of the subjects were detected using a plyometer.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
spirometry
Changes in spirometry (mL) before and after the intervention were tested using an electronic spirometry tester.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
Fecal calprotectin level
Test for changes in fecal calprotectin (FCP) levels in subjects before and after the intervention.The normal range for FCP is less than 100 ng/mL.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
C-reaction protein level
To test for changes in subjects' C-reactive protein (CPR) levels before and after the intervention.The normal range for CRP is less than 5.2 mg/l for adult males and less than 4.6 mg/l for adult females.
Measured: Weeks 0, 4, 8, 12 and 16 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized controlled study divided into intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ping An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping An, Renmin Hospital of Wuhan University
- Investigators
- Ping An, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427135
- Sponsor's protocol ID
- WDRY2024-K058
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in Inflammatory Bowel Disease: a Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06427135
- Acronym / sponsor ID
- WDRY2024-K058
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Exercise interventions, Inflammatory Bowel Diseases, Wearable Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ping AnUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 2024 (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.
This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.
Detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory bowel disease that mainly involves the digestive system, including Crohn's disease (CD) and ulcerative colitis (UC).CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation and intestinal obstruction. CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation, and intestinal obstruction; UC is characterized by diarrhea, mucopurulent blood stools, and abdominal pain, and the peak age of onset is between 15 and 40 years old. Notably, many studies have shown that patients with inflammatory bowel disease commonly suffer from malnutrition, low body mass index (BMI), muscle atrophy, decreased bone density, and fatigue and anxiety, and that surgery is not a one-time event, with patients often requiring several surgeries.
Current treatment strategies focus on medication, nutritional support and nursing care, neglecting other possible adjunctive treatments.
Exercise interventions, as an effective adjunctive therapy for inflammatory bowel disease, have been shown to have anti-inflammatory, anti-muscle atrophic, and physical enhancement effects, improve psychological status, and also have beneficial effects on intestinal flora and intestinal absorption. Exercise is also economical, efficient and highly feasible, making it more acceptable to IBD patients. With the integration of physical medicine and the implementation of Healthy China, the role of exercise intervention in the majority of patients will be more important and its application will be more extensive.
Multimodal wearable device is a simple and efficient miniaturized smart device commonly used in the field of exercise, which can monitor the wearer's heart rate, blood oxygen, step count, exercise data in real time, etc. This group proposes to combine the multimodal wearable device as an auxiliary device with the exercise intervention for patients with inflammatory bowel disease (IBD), which is the first of its kind in China.
Most of the current studies are conducted on the conditions of small samples, single period, and single exercise modality, lack of studies on large samples and multi index evaluation, and the field has not yet formed a unified consensus on personalized exercise intervention for different levels of patients. There is still considerable work to be done on the study of exercise interventions for the treatment of inflammatory bowel disease.
Therefore, this group proposes to conduct a randomized controlled trial to investigate the effects of exercise intervention on body composition and disease progression in patients with inflammatory bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled study divided into intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Exercise interventions | Experimental | Behavioral: Exercise interventionsAdding exercise intervention therapy to existing medications |
| Conventional drug therapy | No intervention | –No exercise intervention, use of existing medication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Commitment to comply with the study procedures and cooperate in the implementation of the full study
- Age ≥ 18 years old, gender is not limited
- Muscle strength examination of all four limbs is greater than or equal to grade 3
- Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission
- Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety
Key exclusion criteria (10 listed)
- Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control
- Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc
- Persons with unstable vital signs
- Presence of cognitive, communication disorders
- Patients who have recently undergone gastrointestinal surgery (<1 month) or who have not fully healed
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 |
|---|---|---|
| Exercise interventionsRehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise. | Behavioural | Exercise interventions |
Primary outcome
skeletal muscle mass index
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P < 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m^2.
8 secondary outcomes
Quality of life rating
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Psychological assessment
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Fatigue status assessment
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
body fat percentage
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
muscle power
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
spirometry
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Fecal calprotectin level
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
C-reaction protein level
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ping An principal investigator
Renmin Hospital of Wuhan University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise interventions in people with Inflammatory Bowel Diseases, run by Ping An.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping An (+8618627068700, anping_05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle mass index (time frame: Weeks 0, 4, 8, 12 and 16 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.