Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:49 AM
Study NCT ID:
NCT07482995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Baduanjin Exercise on Improving Health in Sedentary Young and Middle-Aged Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing', 'timeFrame': 'at baseline and Week 13.', 'description': 'Measured by Cardiopulmonary Exercise Testing (CPET).'}], 'secondaryOutcomes': [{'measure': 'Change in Sit-and-Reach Distance', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Assessed by the standard sit-and-reach test.'}, {'measure': 'Change in Active Range of Motion of the Shoulder, Hip, Knee, and Ankle joints assessed by Goniometry', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a goniometer'}, {'measure': 'Change in Time Spent in Sedentary Behavior assessed by the International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'at baseline and Week 13.'}, {'measure': 'Scores on the Exercise Benefits/Barriers Scale (EBBS)', 'timeFrame': 'at baseline and Week 13', 'description': 'The scale consists of two subscales: the Exercise Benefits Subscale (29 items) and the Exercise Barriers Subscale (14 items). The total score ranges from 43 to 172, with a higher score indicating a more positive perception towards exercise.'}, {'measure': 'Change in Knee Extension Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Maximum torque generated during knee extension'}, {'measure': 'Change in Knee Extension Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Total work performed during repeated maximal knee extension contractions.'}, {'measure': 'Change in Knee Extension Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13.'}, {'measure': 'Change in Knee Extension Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13.'}, {'measure': 'Change in Knee Flexion Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Maximum torque generated during Knee Flexion measured at a preset angular velocity'}, {'measure': 'Change in Knee Flexion Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Total work performed during repeated maximal Knee Flexion contractions'}, {'measure': 'Change in Knee Flexion Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Knee Flexion Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Shoulder Flexion Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Maximum torque generated during Shoulder Flexion, measured at a preset angular velocity.'}, {'measure': 'Change in Shoulder Flexion Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Total work performed during repeated maximal Shoulder Flexion contractions'}, {'measure': 'Change in Shoulder Flexion Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Shoulder Flexion Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Shoulder Abduction Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Maximum torque generated during Shoulder Abduction , measured at a preset angular velocity'}, {'measure': 'Change in Shoulder Abduction Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Total work performed during repeated maximal Shoulder Abduction contractions'}, {'measure': 'Change in Shoulder Abduction Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Shoulder Abduction Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Elbow Extension Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Maximum torque generated during Elbow Extension, measured at a preset angular velocity'}, {'measure': 'Change in Elbow Extension Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Total work performed during repeated maximal Elbow Extension contractions'}, {'measure': 'Change in Elbow Extension Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Elbow Extension Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Elbow Flexion Peak Torque assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Maximum torque generated during Elbow Flexion, measured at a preset angular velocity'}, {'measure': 'Change in Elbow Flexion Total Work assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13', 'description': 'Total work performed during repeated maximal Elbow Flexion contractions'}, {'measure': 'Change in Elbow Flexion Average Power assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Elbow Flexion Fatigue Index assessed by Isokinetic Dynamometry', 'timeFrame': 'at baseline, Week 8, and Week 13'}, {'measure': 'Change in Rhythmic Weight Shift (RWS) Score assessed by Computerized Dynamic Posturography', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a computerized dynamic posturography system.'}, {'measure': 'Change in Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Score assessed by Computerized Dynamic Posturography', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a computerized dynamic posturography system.'}, {'measure': 'Change in Sensory Organization Test (SOT) Composite Score assessed by Computerized Dynamic Posturography', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a computerized dynamic posturography system.'}, {'measure': 'Change in Motor Control Test (MCT) Latency assessed by Computerized Dynamic Posturography', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a computerized dynamic posturography system.'}, {'measure': 'Change in Limits of Stability (LOS) Score assessed by Computerized Dynamic Posturography', 'timeFrame': 'at baseline, Week 8, and Week 13.', 'description': 'Measured using a computerized dynamic posturography system.'}, {'measure': 'Change in Muscle Mass assessed by Bioelectrical Impedance Analysis', 'timeFrame': 'at baseline and Week 13.'}, {'measure': 'Change in Body Fat Percentage assessed by Bioelectrical Impedance Analysis', 'timeFrame': 'at baseline and Week 13.'}, {'measure': 'Change in Fat-Free Mass assessed by Bioelectrical Impedance Analysis', 'timeFrame': 'at baseline and Week 13.'}, {'measure': 'Change in Waist-to-Hip Ratio', 'timeFrame': 'at baseline and Week 13.', 'description': 'Ratio of waist circumference to hip circumference'}, {'measure': 'Change in Center of Mass Sway Amplitude during Baduanjin Exercise assessed by 3D Motion Capture', 'timeFrame': 'at baseline and Week 13', 'description': "Magnitude of anteroposterior and mediolateral displacement of the body's center of mass during static postures of Baduanjin, analyzed using a markerless 3D motion capture system"}, {'measure': 'Change in Joint Range of Motion during Baduanjin Exercise assessed by 3D Motion Capture', 'timeFrame': 'at baseline and Week 13', 'description': 'Angular displacement of primary joints during the performance of Baduanjin movements, analyzed using a markerless 3D motion capture system.'}, {'measure': 'Change in Center of Mass Height during Baduanjin Exercise assessed by 3D Motion Capture', 'timeFrame': 'at baseline and Week 13'}, {'measure': 'Change in Integrated Electromyography (iEMG) during Baduanjin Exercise assessed by Surface Electromyography', 'timeFrame': 'at baseline and Week 13'}, {'measure': 'Change in Root Mean Square (RMS) Amplitude during Baduanjin Exercise assessed by Surface Electromyography', 'timeFrame': 'at baseline and Week 13'}, {'measure': 'Change in Glycemic Control Biomarkers', 'timeFrame': 'at baseline and Week 13.', 'description': 'Fasting venous blood samples will be analyzed for indicators of glucose metabolism, such as glycated hemoglobin (HbA1c) and fasting insulin.'}, {'measure': 'Change in Lipid Profile', 'timeFrame': 'at baseline and Week 13.', 'description': 'Fasting venous blood samples will be analyzed for indicators of lipid metabolism, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).'}, {'measure': 'Change in Inflammatory and Neurotrophic Biomarkers', 'timeFrame': 'at baseline and Week 13.', 'description': 'Fasting venous blood samples will be analyzed for inflammatory markers (e.g., high-sensitivity C-reactive protein \\[hs-CRP\\], interleukin-6 \\[IL-6\\], tumor necrosis factor-alpha \\[TNF-α\\]) and brain-derived neurotrophic factor (BDNF).'}, {'measure': 'Percentage of Prescribed Baduanjin Sessions Completed', 'timeFrame': 'Through study completion, up to Week 13.'}, {'measure': 'Baduanjin Movement Quality Score assessed by Blinded Expert Review (100-point scale)', 'timeFrame': 'at Week 13', 'description': 'Score assessed by blinded experts using a standardized 100-point scoring rubric. Scores range from 0 to 100, with a higher score indicating better movement quality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedentary Lifestyle', 'Behavioral Intervention']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are:\n\n1. Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)?\n2. Does it improve their body composition, muscle strength, balance, and flexibility?\n3. Does it reduce their daily sitting time?\n\nResearchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes.\n\nParticipants will:\n\n1. Be randomly assigned to one of the two groups.\n2. If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks.\n3. Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 59 years\n* Sedentary and physically inactive, defined as: (a) self-reported sitting time ≥ 8 hours per day, AND (b) not meeting the World Health Organization (WHO) recommended level of physical activity ( engaging in \\< 150 minutes of moderate-to-vigorous intensity physical activity per week, assessed by the International Physical Activity Questionnaire \\[IPAQ\\])\n* In good general health as self-reported, and free from any known diseases\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications to cardiopulmonary exercise testing\n* Currently participating in, or planning to participate within the next 3 months, in any other structured exercise or behavioral intervention program\n* Pregnancy, lactation, or planning to become pregnant during the study period\n* Inability to understand or comply with the study procedures'}, 'identificationModule': {'nctId': 'NCT07482995', 'briefTitle': 'Effects of Baduanjin Exercise on Improving Health in Sedentary Young and Middle-Aged Adults', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'A Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Mechanisms of Baduanjin on Improving Health Outcomes in Sedentary Young and Middle-Aged Adults', 'orgStudyIdInfo': {'id': 'Shoufa 2024-1-4061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baduanjin Training Group', 'description': 'Participants in this group will receive a 12-week Baduanjin exercise program. The program consists of supervised group sessions combined with home-based practice, with a frequency of 5 sessions per week. Each session lasts 60 minutes, including warm-up, standardized Baduanjin practice, and cool-down. The Baduanjin exercises follow a standardized protocol.', 'interventionNames': ['Behavioral: Baduanjin exercise']}, {'type': 'OTHER', 'label': 'Health Education Control Group', 'description': 'Participants in this group will receive general health education, which includes recommendations on physical activity types and duration (e.g., following the WHO guidelines). However, they will not be enrolled in any structured, supervised exercise program. They will be instructed to maintain their usual lifestyle throughout the study period.', 'interventionNames': ['Other: General Health Education']}], 'interventions': [{'name': 'Baduanjin exercise', 'type': 'BEHAVIORAL', 'description': 'A 12-week, standardized Baduanjin exercise program. Participants will complete 5 sessions per week, each lasting 60 minutes (including warm-up, Baduanjin practice, and cool-down). The program includes both supervised group sessions and guided home practice.', 'armGroupLabels': ['Baduanjin Training Group']}, {'name': 'General Health Education', 'type': 'OTHER', 'description': 'Participants will receive general health education (including recommendations on physical activity types and duration), but will not be enrolled in any structured or supervised exercise program. They will be instructed to maintain their usual lifestyle.', 'armGroupLabels': ['Health Education Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jingyi Ren, M.D., Chief Physician', 'role': 'CONTACT', 'email': 'renjingyi@cjfh.org.cn', 'phone': '18600195099'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jingyi Ren', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}