Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:42 AM
Study NCT ID:
NCT07165106
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistance and Aerobic Exercises on Walking and Sarcopenic Parameters in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups with a exercise control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go Test (TUG Test)', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': 'The Timed Up and Go (TUG) test measures mobility by timing a participant rising from a chair, walking 3 m, turning, and sitting down. Lower values indicate better performance.\n\nUnit of Measure: seconds'}, {'measure': '4-Meter Walking Speed', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': 'Usual-pace walking speed over a 4-meter course, recorded as distance divided by time. Higher values indicate better performance.\n\nUnit of Measure: meters/second'}, {'measure': 'Short Physical Performance Battery (SPPB) Score', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': 'Composite score including balance tests, 4-meter gait speed, and repeated chair stands; range 0 (worst) to 12 (best). Higher scores indicate better performance.\n\nUnit of Measure: score (0-12)'}, {'measure': 'Handgrip Strength', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': 'Maximal isometric handgrip strength of the dominant hand measured with a handheld dynamometer. Higher values indicate better strength'}, {'measure': 'Five Times Chair Stand Test', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': 'Time (in seconds) to rise from a chair and sit back down five consecutive times without using arms. Lower values indicate better performance.\n\nUnit of Measure: seconds'}], 'secondaryOutcomes': [{'measure': 'MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living', 'timeFrame': 'BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)', 'description': "The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II assesses the motor aspects of experiences of daily living in patients with Parkinson's disease. It is a patient-reported questionnaire evaluating difficulties in speech, saliva and drooling, chewing and swallowing, handwriting, dressing, hygiene, turning in bed, walking and balance, tremor, and fine motor tasks. Each item is scored on a 0-4 scale, with higher scores reflecting greater disability. The total score provides an index of motor impairment in daily life activities."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'sarcopenia', 'exercises'], 'conditions': ['PARKINSON DISEASE (Disorder)', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': "The aim of this study was to investigate the effects of resistance and aerobic exercises on the following outcomes in patients with sarcopenic Parkinson's disease: Timed Up and Go Test (TUG), gait speed, Short Physical Performance Battery (SPPB), handgrip strength, Five-Times Sit-to-Stand Test, and MDS-UPDRS Part II scores.", 'detailedDescription': 'Female and male patients aged between 40 and 85 years, who meet the inclusion criteria, will be recruited from the Outpatient Clinic of Physical Medicine and Rehabilitation (PMR), Ahi Evran University Kırşehir Training and Research Hospital. A total of 30 participants will be enrolled in the study.\n\nThis is a prospective, randomized, controlled trial. Assessments will be performed at baseline (week 0), at the end of treatment (week 6), and at follow-up (week 12). Outcome measures will include:\n\nHandgrip strength Timed Up and Go Test (TUG) 4-meter gait speed test Short Physical Performance Battery (SPPB) Five-Times Sit-to-Stand Test (5CST) MDS-UPDRS Part II questionnaire\n\nIn addition, at baseline, ultrasonographic measurement of anterior thigh muscle thickness will be performed. This value, expressed in millimeters, will be divided by the body mass index (BMI) to calculate the STAR (Sonographic Thigh Adjustment Ratio) index.Participants will be randomized into three treatment groups:\n\nGroup 3 (Conventional Rehabilitation Program):\n\nPatients will receive a standard physical therapy program, 5 days per week, for 1 hour per session. The protocol will include range of motion exercises for upper and lower extremities, stretching, walking, balance and coordination training, proprioceptive exercises, postural exercises, obstacle negotiation training, and turning-in-place exercises.\n\nGroup 2 (Conventional Rehabilitation + Resistance Training):\n\nIn addition to the conventional program, patients will perform resistance exercises for major muscle groups of the upper and lower extremities using elastic resistance bands, 3 days per week.\n\nGroup 1 (Conventional Rehabilitation + Treadmill Training):\n\nIn addition to the conventional program, patients will undergo treadmill exercise consisting of a 5-minute warm-up, 15 minutes of main exercise, and 5 minutes of cool-down. Walking speed will be individually adjusted according to participant tolerance, and exercise intensity will be monitored using the Borg Rating of Perceived Exertion (RPE) scale. Treadmill speed will be progressively increased in subsequent sessions under controlled conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients aged 40-85 years with a clinical diagnosis of Parkinson's disease.\n* Diagnosis of sarcopenia according to the EWGSOP2 criteria.\n* Hoehn \\& Yahr stage 2-3.\n* Ability and willingness to provide written informed consent according to the approved study consent form.\n\nExclusion Criteria:\n\n* Failure to meet diagnostic criteria for sarcopenia.\n* Hoehn \\& Yahr stage 1 or 4.\n* History of malignancy.\n* Epilepsy.\n* History of cardiac pacemaker implantation.\n* Presence of congestive heart failure.\n* Orthopedic conditions affecting walking or balance.\n* Respiratory disorders impairing exercise capacity.\n* Uncontrolled hypertension.\n* Inability to cooperate with study procedures.\n* History of neuromuscular or vestibular disorders affecting gait or balance parameters.\n* Lack of willingness to participate in the study."}, 'identificationModule': {'nctId': 'NCT07165106', 'briefTitle': "Effects of Resistance and Aerobic Exercises on Walking and Sarcopenic Parameters in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evran University Education and Research Hospital'}, 'officialTitle': "Comparison of the Effects of Resistance and Aerobic Exercises Added to Conventional Rehabilitation Program on Walking and Sarcopenic Parameters in Patients With Sarcopenic Parkinson's Disease", 'orgStudyIdInfo': {'id': 'AhiEvranUERH-FTR-NST-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional rehabilitation + Aerobic exercise', 'description': 'Participants will receive a standard conventional rehabilitation program combined with supervised aerobic exercise training (e.g., treadmill ) according to guideline-based frequency, intensity, and duration.', 'interventionNames': ['Behavioral: Aerobic Exercise', 'Behavioral: Conventional Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional rehabilitation + Resistance exercises', 'description': 'Participants will receive a standard conventional rehabilitation program combined with supervised resistance exercise training targeting major muscle groups with free weights or elastic bands.', 'interventionNames': ['Behavioral: Resistance Exercise', 'Behavioral: Conventional Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional rehabilitation', 'description': 'Participants will receive only the standard conventional rehabilitation program without any additional aerobic or resistance exercise.', 'interventionNames': ['Behavioral: Conventional Rehabilitation']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Aerobic training'], 'description': 'Participants in this group will receive conventional rehabilitation in combination with supervised treadmill-based aerobic exercise three times per week for 6 weeks. Each exercise session will consist of a 5-minute warm-up, a 15-minute main exercise phase, and a 5-minute cool-down. Walking speed will be individualized based on participant tolerance and progressively increased under clinical supervision. Exercise intensity will be monitored using the modified Borg Rating of Perceived Exertion (scale 6-20).\n\nWeeks 1-2: Main exercise at Borg 10-11 (light-moderate).\n\nWeeks 3-4: Main exercise at Borg 11-12 (moderate).\n\nWeeks 5-6: Main exercise at Borg 12-13 (moderate-high).\n\nCardiorespiratory responses will be monitored during all sessions, and treadmill speed will be gradually adjusted in accordance with improvements in exercise tolerance while maintaining safety.', 'armGroupLabels': ['Conventional rehabilitation + Aerobic exercise']}, {'name': 'Resistance Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Resistance training'], 'description': 'Participants in this arm will receive conventional rehabilitation combined with supervised resistance training using elastic bands, 3 times per week for 6 weeks. Exercises target major upper- and lower-limb and hip muscles. Each exercise is performed for 3 sets of 10 repetitions with 60-90 seconds rest. Initial band tension is set at the highest tolerable level and progressively increased. The program includes shoulder press, biceps curl, triceps extension, seated leg extension, calf raise, and lateral band walk. All sessions are supervised, emphasizing correct posture, controlled full range of motion, and avoidance of compensatory movements. Patients are guided with verbal and visual cues when necessary.', 'armGroupLabels': ['Conventional rehabilitation + Resistance exercises']}, {'name': 'Conventional Rehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['Conventional therapy'], 'description': 'Participants in this group will receive conventional rehabilitation only, 5 days per week, 1 hour per day, for 6 weeks. The program includes upper and lower limb range of motion exercises, stretching, walking practice, balance and coordination training, proprioceptive exercises, posture correction, obstacle crossing, and turning in place. All sessions are delivered under clinical supervision, with emphasis on correct posture, safety, and full range of motion', 'armGroupLabels': ['Conventional rehabilitation', 'Conventional rehabilitation + Aerobic exercise', 'Conventional rehabilitation + Resistance exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Kırşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'NEDİME SEVEN TAŞ', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'FİGEN TUNCAY', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'İSMAİL CEYLAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kırşehir Ahi Evran University', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'NEDİME SEVEN TAŞ', 'role': 'CONTACT', 'email': 'nedime7seven@gmail.com', 'phone': '+905448203214'}, {'name': 'FİGEN TUNCAY', 'role': 'CONTACT', 'email': 'figentuncay3206@hotmail.com', 'phone': '+905353046401'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evran University Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nedime Seven Tas', 'investigatorAffiliation': 'Ahi Evran University Education and Research Hospital'}}}}