Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-10 @ 6:57 AM
Study NCT ID:
NCT07470060
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Core Stability Training Using Pilates on Core Muscle Strength, Pulmonary Function, and Cardio-respiratory Fitness in the Elderly.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and instructors could not be blinded due to the nature of exercise interventions. However, the outcome assessors and data analysts were blinded to the group assignments.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A three-arm, randomized, parallel-group trial. Participants were assigned to one of three groups: Mat Pilates Training, Aerobic Training, or Control, with a 1:1:1 allocation ratio.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Stability (Prone Bridge Test)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8).', 'description': 'The total time that the participant can maintain a neutral spine position during the Prone Bridge (Plank) Test. This measures the endurance of the core stabilizing muscles. Unit of Measure: Seconds'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'The total volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, measured via a calibrated computerized spirometer following ATS guidelines. Unit of Measure: Liters'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'The volume of air exhaled during the first second of the Forced Vital Capacity (FVC) maneuver, indicating airway patency. Unit of Measure: Liters'}, {'measure': 'FEV1/FVC Ratio', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'The ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity, used to identify obstructive or restrictive lung patterns. Unit of Measure: Percentage'}, {'measure': 'Forced Expiratory Flow at 25-75% (FEF25-75%)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'The average flow rate during the middle half of the FVC maneuver, often used as an indicator of small airway function. Unit of Measure: Liters per second'}, {'measure': 'Maximum Voluntary Ventilation (MVV)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'The maximum amount of air that can be inhaled and exhaled within one minute, reflecting the overall function of the respiratory system and muscle strength. Unit of Measure: Liters per minute'}, {'measure': 'Six-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'A measure of cardiorespiratory fitness and functional exercise capacity. The total distance covered by walking as far as possible on a 40-meter flat course in 6 minutes is recorded. Unit of Measure: Meters'}, {'measure': 'Lower Body Flexibility (Sit-and-Reach Test)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'Assessment of hamstring and lower back flexibility. Measured as the distance reached forward while sitting with legs extended. Unit of Measure: Centimeters'}, {'measure': 'Upper Body Flexibility (Back-Scratch Test)', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': 'Assessment of shoulder flexibility and range of motion. Measured as the distance between the fingertips of both hands behind the back (positive for overlap, negative for a gap). Unit of Measure: Centimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mat Pilates', 'Older Adults', 'Pulmonary Function', '6-Minute Walk Test', 'Core Strengthening', 'Cardiorespiratory Fitness', 'Exercise Intervention'], 'conditions': ['Healthy Aging', 'Physical Fitness', 'Core Stability', 'Respiratory Function']}, 'descriptionModule': {'briefSummary': 'This study investigates how different types of exercise-specifically Mat Pilates and Aerobic training-can help improve the physical health and breathing capacity of healthy older adults aged 60 to 77.\n\nAs we age, our bodies naturally experience a decline in core strength and lung function, which can make daily activities more tiring. The goal of this research is to compare whether the specialized breathing and core-strengthening techniques of Pilates provide better results for respiratory health and physical endurance than traditional treadmill walking.\n\nStudy Structure\n\nA total of 29 participants from Nakhon Si Thammarat, Thailand, were randomly assigned to one of three groups:\n\nPilates Group: Practicing Mat Pilates sessions focused on core stability and controlled breathing.\n\nAerobic Group: Performing moderate-intensity treadmill walking.\n\nControl Group: Maintaining their normal daily routine without a structured exercise program.\n\nDuration \\& Intensity Both exercise groups trained for 60 minutes, three times a week, over an 8-week period. By comparing these groups, the study aims to identify effective exercise options that can help seniors maintain their independence and improve their quality of life.', 'detailedDescription': 'This randomized controlled trial (RCT) utilizes a three-arm parallel-group design to examine the comparative impacts of Mat Pilates and aerobic exercise on pulmonary function, core muscle strength, flexibility, and cardiorespiratory fitness in healthy older adults.\n\nMethodology and Participants:\n\nTwenty-nine healthy, non-smoking older adults (aged 60-77) were enrolled. Participants were stratified by sex, age, and baseline core stability (assessed via the plank test) before being randomly assigned to the Pilates Training Group (PTG), Aerobic Training Group (ATG), or Control Group (CON).\n\nIntervention Protocol:\n\nPilates Group (PTG): An 8-week program consisting of 60-minute sessions, three times weekly. The sessions focus on lateral breathing mechanics and core activation ("the powerhouse"), including multi-directional stepping and trunk rotation, maintained at 55%-70% of Heart Rate Reserve (HRR).\n\nAerobic Group (ATG): Moderate-intensity treadmill walking for 60 minutes, three times weekly, also maintained at 55%-70% HRR.\n\nControl Group (CON): Participants were instructed to maintain their usual lifestyle and physical activity levels.\n\nKey Assessments:\n\nOutcome measures include pulmonary function (spirometry: FVC, FEV1, MVV), core endurance (prone bridge test), lower and upper body flexibility (sit-and-reach and back-scratch tests), and functional aerobic capacity (6-Minute Walk Test).\n\nThe study aims to bridge the gap in clinical literature regarding which exercise modality offers superior benefits for the "core-pulmonary" synergy-the relationship between trunk stability and respiratory efficiency-in the aging population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy older adults aged 60-77 years.\n* Non-smokers.\n* Capable of independent movement and daily activities.\n* Not engaged in any structured exercise program for at least 6 months prior to enrollment.\n* Free from dietary supplementation for at least 6 months.\n* Controlled hypertension (120-159/80-99 mmHg) with physician clearance.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cardiovascular or respiratory diseases.\n* Acute or chronic musculoskeletal conditions (e.g., spondylolisthesis, scoliosis, arthritis, or gout).\n* Severe back pain or tendinitis that hinders exercise.\n* Uncontrolled hypertension.\n* Use of medications that significantly affect heart rate or physical performance.'}, 'identificationModule': {'nctId': 'NCT07470060', 'acronym': 'PLT-AER-ELD', 'briefTitle': 'Effects of Core Stability Training Using Pilates on Core Muscle Strength, Pulmonary Function, and Cardio-respiratory Fitness in the Elderly.', 'organization': {'class': 'OTHER', 'fullName': 'Walailak University'}, 'officialTitle': 'Effects of Core Stability Training Using Pilates on Core Muscle Strength, Pulmonary Function, and Cardio-respiratory Fitness in the Elderly', 'orgStudyIdInfo': {'id': 'WUEC-24-333-01'}, 'secondaryIdInfos': [{'id': 'Grant Contract Number: WU67252', 'type': 'OTHER_GRANT', 'domain': 'New Researcher Development Scheme of Walailak University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates Training Group (PTG)', 'description': 'Participants receive an 8-week Mat Pilates program (60 mins, 3 times/week) focused on core stability and breathing mechanics.', 'interventionNames': ['Behavioral: Mat Pilates Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Training Group (ATG)', 'description': 'Participants perform moderate-intensity treadmill walking (60 mins, 3 times/week) at 55%-70% Heart Rate Reserve.', 'interventionNames': ['Behavioral: Aerobic Exercise (Treadmill Walking)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (CON)', 'description': 'Participants maintain their usual lifestyle and daily activities without any new structured exercise program.'}], 'interventions': [{'name': 'Mat Pilates Program', 'type': 'BEHAVIORAL', 'description': 'A structured 8-week intervention involving 60-minute group sessions, 3 times weekly. Includes 10-minute warm-up, 40-minute Mat Pilates (core activation, limb coordination, and lateral breathing), and 10-minute cool-down. Intensity: 55%-70% HRR.', 'armGroupLabels': ['Pilates Training Group (PTG)']}, {'name': 'Aerobic Exercise (Treadmill Walking)', 'type': 'BEHAVIORAL', 'description': 'An 8-week aerobic program consisting of 60-minute treadmill sessions, 3 times weekly. Includes 10-minute warm-up, 40-minute moderate-intensity walking at 55%-70% HRR, and 10-minute cool-down.', 'armGroupLabels': ['Aerobic Training Group (ATG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80160', 'city': 'Nakhon Si Thammarat', 'state': 'Changwat Nakhon Si Thammarat', 'country': 'Thailand', 'facility': 'School of Medicine, Walailak University', 'geoPoint': {'lat': 8.43333, 'lon': 99.96667}}], 'overallOfficials': [{'name': 'Bulin Jirapongsatorn, Master degree', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine, Walailak University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To protect the privacy and confidentiality of the participants, individual participant data will not be made publicly available. However, the study protocol and statistical analysis plan may be shared upon reasonable request to the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walailak University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chulalongkorn University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}