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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak oxygen uptake (pVO2) (in ml/kg/min)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET)'}], 'secondaryOutcomes': [{'measure': "Crohn's Disease Activity Index (CDAI)", 'timeFrame': 'At baseline, week 4, week 8 and the end of intervention at week 12', 'description': 'Measurement of patient-reported disease activity of CD participants. Higher scores mean higher activity. \\<150 indicates remission, 150\\~219 indicates mildly active.'}, {'measure': 'Partial Mayo Score', 'timeFrame': 'At baseline, week 4, week 8 and the end of intervention at week 12', 'description': 'Measurement of Patient-reported disease activity of UC participants. Higher scores mean higher activity. 0\\~1 indicates remission. 2\\~4 indicates mildly active.'}, {'measure': 'Concentration of fecal calprotectin', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': '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.'}, {'measure': 'Fatigue severity scale (FSS)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'Minimum value is 9 and maximum value is 63 with higher scores indicating higher level of fatigue.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'Score of 0\\~21 with higher scores indicates higher level of anxiety and depression'}, {'measure': 'International Physical Activity Questionnaire (IPAQ) short form', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'A total IPAQ score is the sum of walking, moderate and vigorous metabolic equivalent of task (MET)-min/week.'}, {'measure': 'Body Mass Index (BMI) in kg/m^2', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Waist circumference in cm', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum fasting glucose in mmol/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum albumin in g/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum cholesterol in mmol/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum triglyceride in mmol/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum fasting lipoprotein in mmol/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Concentration of serum uric acid in mmol/L', 'timeFrame': 'At baseline and the end of intervention at week 12'}, {'measure': 'Oxygen uptake at aerobic threshold (in ml/kg/min)', 'timeFrame': 'at baseline and the end of intervention at week 12', 'description': 'Oxygen uptake at aerobic threshold measured by CPET'}, {'measure': 'Peak oxygen uptake per heart rate (in ml/kg/min)', 'timeFrame': 'at baseline and the end of intervention at week 12', 'description': 'Peak oxygen uptake per heart rate measured by CPET'}, {'measure': 'Maximal heart rate (in bpm)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'Maximal heart rate at peak measured by CPET'}, {'measure': 'Six-Minute Walk Test (in meters)', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': 'Maximum walked distance in meters conducted according to guideline'}, {'measure': 'Exercise Benefits/Barriers Scale', 'timeFrame': 'At baseline and the end of intervention at week 12', 'description': "The Exercise Benefits/Barriers Scale (EBBS) will be used to assess participants' perceived benefits and barriers to exercise."}, {'measure': 'Plasma C-reactive protein (mg/L)', 'timeFrame': 'At baseline and end of the intervention at week 12'}, {'measure': 'Plasma hemoglobin level (in g/L)', 'timeFrame': 'At baseline and end of the intervention at week 12'}, {'measure': 'Body fat percentage (%)', 'timeFrame': 'At baseline and end of the intervention at week 12', 'description': 'Body fat percentage measured via body composition analysis'}, {'measure': 'Skeletal muscle mass (kg)', 'timeFrame': 'At baseline and end of the intervention at week 12', 'description': 'Skeletal muscle mass (kg) measured via body composition analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease (IBD)']}, 'descriptionModule': {'briefSummary': "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:\n\n1. Does this aerobic training program improve the cardiopulmonary function of participants?\n2. Does this aerobic training program help control disease activity?\n3. Does this aerobic training program improve participants' quality of life?\n\nResearchers 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.\n\nParticipants will:\n\n1. Take part in the individualized aerobic training program according to their baseline physical activity level for 12 weeks.\n2. Visit the clinic once every 4 weeks for check-ups and tests.\n3. Keep a diary of symptoms.", 'detailedDescription': "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.\n\nParticipants will be given different progressive individualized aerobic training schedules based on their baseline physical activity levels, with the exercise intensity increased every 4 weeks.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with CD or UC for more than 3 months.\n* Disease activity in remission or mildly active (CD: CDAI \\< 220; UC: pMS \\< 5).\n* Baseline physical activity intensity is low, measured by the IPAQ Chinese version short form, and without a habit of "regular exercise".\n* Agree to participate in the study and accept a 12-week individualized aerobic exercise training program.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or planning to become pregnant within the next 3 months.\n* Presence of physical movement disorders or other chronic diseases that limit physical activity.\n* Having an ileostomy.\n* History of anal or intestinal surgery within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT06804733', 'briefTitle': 'Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ningbo Medical Center Lihuili Hospital'}, 'officialTitle': 'Telemedicine-based Individualized Aerobic Exercise Training in Adults With Inactive or Mildly Active Inflammatory Bowel Disease: A Semi-crossover Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY2024SL379-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '12-week control intervention followed by 12-week aerobic exercise training', 'interventionNames': ['Behavioral: 12-week control intervention followed by 12-week aerobic exercise training']}, {'type': 'EXPERIMENTAL', 'label': '12-week aerobic exercise training directly', 'interventionNames': ['Behavioral: 12-week individualized aerobic exercise training']}], 'interventions': [{'name': '12-week individualized aerobic exercise training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['12-week aerobic exercise training directly']}, {'name': '12-week control intervention followed by 12-week aerobic exercise training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['12-week control intervention followed by 12-week aerobic exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315040', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dr. Zhou', 'role': 'CONTACT', 'email': 'drzhouying07@126.com', 'phone': '18395804423'}], 'facility': 'the Affiliated Lihuili Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Ying Zhou, M.D.', 'role': 'CONTACT', 'email': 'drzhouying07@126.com', 'phone': '8618395804423'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Start Date: Upon publication of this clinical trial. End Date: Five years following publication.', 'ipdSharing': 'YES', 'description': 'All IPD collected throughout the trial will be shared.', 'accessCriteria': 'Who can access the data? Researchers who provide a methodologically sound proposal.\n\nFor what types of analysis? To achieve aims in the approved proposal. How can they access it? Proposals should be directed to drzhouying07@126.com. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}