Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:33 AM
Study NCT ID:
NCT07449767
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Short-Term Resistance Training on Diaphragm Thickness, Hepatic Fat Density, and Quality of Life in Healthy Older Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Resistance Training Group (RT) The RT group completed a supervised moderate-intensity resistance training program three times per week for four weeks (30-40 minutes/session, RPE 12-15). The control group maintained usual daily activities.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm Thickness', 'timeFrame': '4 weeks', 'description': 'Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.'}], 'secondaryOutcomes': [{'measure': 'Hepatic Fat Density', 'timeFrame': '4 weeks', 'description': 'Measurement: CT attenuation (Hounsfield Units) Single ROI in segment VIII'}, {'measure': 'SF-12 Physical Health Score', 'timeFrame': '4 weeks', 'description': 'Instrument: Short Form-12 Health Survey The physical and mental health scores of the SF-12 subdimensions range from 0 to 100, with higher scores representing better health.'}, {'measure': 'SF-12 Mental Health Score', 'timeFrame': '4 weeks', 'description': 'Instrument: Short Form-12 Health Survey The physical and mental health scores of the SF-12 subdimensions range from 0 to 100, with higher scores representing better health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older men', 'Quality of life', 'Fatty liver', 'Diaphragm thickness', 'Resistance training', 'Aging'], 'conditions': ['Older Men', 'Quality of Life', 'Fatty Liver', 'Resistance Training', 'Aging']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigated the effects of a four-week moderate-intensity resistance training program on diaphragm thickness, hepatic fat density, and health-related quality of life in healthy community-dwelling older men aged 60-75 years. Thirty participants were randomly assigned to a resistance training group or control group. Diaphragm thickness and hepatic attenuation were assessed using non-contrast computed tomography, and quality of life was evaluated using the SF-12 questionnaire. The primary outcome was change in diaphragm thickness. Secondary exploratory outcomes included hepatic fat density and SF-12 physical and mental health scores.', 'detailedDescription': 'Aging is associated with progressive decline in respiratory muscle morphology, metabolic health, and perceived quality of life. While resistance training is well established for peripheral muscle adaptation, its short-term effects on diaphragm morphology and hepatic tissue density remain insufficiently investigated.\n\nThis randomized controlled pre-test-post-test trial enrolled 30 healthy men aged 60-75 years. Participants were randomly allocated (1:1) to:\n\nResistance Training Group (RT) Control Group (CON) The RT group completed a supervised moderate-intensity resistance training program three times per week for four weeks (30-40 minutes/session, RPE 12-15). The control group maintained usual daily activities.\n\nPrimary Outcome:\n\nChange in diaphragm thickness (mm) assessed by non-contrast CT\n\nSecondary Outcomes (Exploratory):\n\nHepatic attenuation (Hounsfield Units) via CT SF-12 Physical Health Score SF-12 Mental Health Score The study was approved by the Hitit University Scientific Research Ethics Committee (2025/0464) and conducted according to the Declaration of Helsinki.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 60-75 years\n* Community-dwelling and functionally independent\n* No structured exercise program in past 6 months\n* No musculoskeletal injury in past 6 months\n* Ability to provide written informed consent\n* Stable neuropsychological status\n\nExclusion Criteria:\n\n* Chronic liver disease\n* Uncontrolled cardiovascular or pulmonary disease\n* Recent respiratory infection\n* Use of medications affecting muscle or liver metabolism (e.g., systemic corticosteroids, anabolic agents, hepatotoxic drugs)\n* Participation in structured exercise or respiratory training within past 6 months\n* Unstable thyroid hormone replacement therapy'}, 'identificationModule': {'nctId': 'NCT07449767', 'acronym': 'RT-DIA-OLDER', 'briefTitle': 'Effects of Short-Term Resistance Training on Diaphragm Thickness, Hepatic Fat Density, and Quality of Life in Healthy Older Men', 'organization': {'class': 'OTHER', 'fullName': 'Gümüşhane Universıty'}, 'officialTitle': 'Effects of Short-Term Resistance Training on Diaphragm Thickness, Hepatic Fat Density, and Quality of Life in Healthy Older Men: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025/019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Training Group (RT)', 'description': 'Participants performed supervised resistance training three times per week for four weeks. Each session lasted 30-40 minutes and included:\n\nLower body exercises (sit-to-stand, step-ups, glute bridge) Upper body exercises (wall push-ups, resistance band row, biceps curl) Core exercises Breathing exercises (diaphragmatic breathing, pursed-lip breathing) Warm-up protocol (10 minutes dynamic mobility) Intensity: Borg RPE 12-15 Rest interval: 60 seconds between sets', 'interventionNames': ['Behavioral: Resistance Training Group (RT)', 'Other: Control']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'Participants maintained their usual daily routines without structured exercise intervention.'}], 'interventions': [{'name': 'Resistance Training Group (RT)', 'type': 'BEHAVIORAL', 'description': 'Structured Moderate-Intensity Resistance Training', 'armGroupLabels': ['Resistance Training Group (RT)']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Participants maintained their usual daily routines without structured exercise intervention.', 'armGroupLabels': ['Resistance Training Group (RT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29600', 'city': 'Gümüşhane', 'state': 'Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane', 'country': 'Turkey (Türkiye)', 'facility': 'Gumushane Univetsity', 'geoPoint': {'lat': 40.46001, 'lon': 39.47176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to the absence of prior consent for data sharing and the potential risk of re-identification in a small, single-center sample. Only aggregate results will be disseminated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gümüşhane Universıty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC. PROF.', 'investigatorFullName': 'Coşkun YILMAZ', 'investigatorAffiliation': 'Gümüşhane Universıty'}}}}