Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-02 @ 1:43 PM
Study NCT ID:
NCT07013604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenia and Intervention Physical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This study uses single-blind masking. While participants are aware of their group assignment due to the nature of the interventions (especially NMES and resistance training), outcome assessors who perform the post-intervention evaluations (e.g., muscle strength, functional performance, and quality of life) will be blinded to group allocation. This is done to reduce assessment bias and ensure objective measurement of outcomes.\n\nAdditionally, the control group receives a placebo treatment (being connected to a non-active neuromusculoskeletal device), which helps reduce the psychological effects of knowing they are not receiving active intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study follows a randomised controlled trial (RCT) design involving 60 elderly participants aged 60-75 years diagnosed with sarcopenia according to EWGSOP2 criteria. Participants will be randomly assigned to three groups (n = 20 each).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Muscle Mass', 'timeFrame': '2 month', 'description': 'Assessed using Bioelectrical Impedance Analysis (BIA) to measure skeletal muscle mass.\n\nEvaluation is done pre- and post-intervention to detect changes in the Skeletal Muscle Index (SMI), based on EWGSOP2 criteria'}], 'secondaryOutcomes': [{'measure': 'Muscle Strength Handheld dynamometer (e.g., MicroFET)', 'timeFrame': '2 month', 'description': 'Isometric knee extension strength\n\nMeasurement: Pre- and post-intervention, using the highest or average value from 2-3 trials.'}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': '2 month', 'description': 'Assesses eight domains of health-related quality of life, scored from 0 to 100. Administered before and after the intervention period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the effectiveness of neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) in improving muscle mass, strength, functional performance, and quality of life in elderly individuals diagnosed with sarcopenia', 'detailedDescription': 'Sarcopenia, the age-related decline in muscle mass, strength, and function, significantly affects the health and independence of elderly individuals. It increases the risk of frailty, falls, and disability. Neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) are promising rehabilitation strategies for older adults with limited physical capacity. This study aims to compare the effectiveness of NMES and BFR in managing sarcopenia and improving physical and functional outcomes in the elderly'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older age (≥ 60-75 years)\n\nLow muscle strength (e.g., low handgrip strength)\n\nLow muscle mass (e.g., ASM/height² below cutoff)\n\nExclusion Criteria:\n\n* heart disese\n* kidny disese\n* autoimune disese\n* cognetive disorder\n* sever form of sarcopenia'}, 'identificationModule': {'nctId': 'NCT07013604', 'briefTitle': 'Sarcopenia and Intervention Physical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Pharos University in Alexandria'}, 'officialTitle': 'Effectiveness of Neuromuscular Electrical Stimulation Versus Low-load Resistance Training With Blood Flow Restriction in Elderly Individuals With Sarcopenia', 'orgStudyIdInfo': {'id': 'sarcopenia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular Electrical Stimulation (NMES) Group', 'description': 'Participants receive neuromuscular electrical stimulation (NMES) targeting the quadriceps and hamstrings, 30 minutes per session, 3 times per week for 8 weeks', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance + BFR Group', 'description': 'Participants perform low-load resistance training (30% 1RM) combined with blood flow restriction using pneumatic cuffs, 30 minutes per session, 3 times per week for 8 weeks', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants receive placebo treatment by being connected to a neuromusculoskeletal device that is turned off (no actual stimulation), with no active intervention during the 8-week period', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group']}], 'interventions': [{'name': 'Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group', 'type': 'DEVICE', 'description': 'NMES Group: Receives neuromuscular electrical stimulation to the thigh muscles for 30 minutes, three times per week, over 8 weeks.\n\nResistance + BFR Group: Performs low-load resistance exercises with blood flow restriction applied to the thighs, also for 30 minutes per session, three times per week, over 8 weeks.\n\nControl Group: Receives placebo treatment using a turned-off stimulation device with no active intervention during the 8-week period.', 'armGroupLabels': ['Control Group', 'Neuromuscular Electrical Stimulation (NMES) Group', 'Resistance + BFR Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharos University in Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ola mohamed elsayed elgohary', 'investigatorFullName': 'Ola Mohamed Elsayed Elgohary', 'investigatorAffiliation': 'Pharos University in Alexandria'}}}}