- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449767
Effects of Short-Term Resistance Training on Diaphragm Thickness, Hepatic Fat Density, and Quality of Life in Healthy Older Men (RT-DIA-OLDER)
Effects of Short-Term Resistance Training on Diaphragm Thickness, Hepatic Fat Density, and Quality of Life in Healthy Older Men: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
This randomized controlled pre-test-post-test trial enrolled 30 healthy men aged 60-75 years. Participants were randomly allocated (1:1) to:
Resistance 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.
Primary Outcome:
Change in diaphragm thickness (mm) assessed by non-contrast CT
Secondary Outcomes (Exploratory):
Hepatic 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane
-
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye), 29600
- Gumushane Univetsity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male
- Age 60-75 years
- Community-dwelling and functionally independent
- No structured exercise program in past 6 months
- No musculoskeletal injury in past 6 months
- Ability to provide written informed consent
- Stable neuropsychological status
Exclusion Criteria:
- Chronic liver disease
- Uncontrolled cardiovascular or pulmonary disease
- Recent respiratory infection
- Use of medications affecting muscle or liver metabolism (e.g., systemic corticosteroids, anabolic agents, hepatotoxic drugs)
- Participation in structured exercise or respiratory training within past 6 months
- Unstable thyroid hormone replacement therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Training Group (RT)
Participants performed supervised resistance training three times per week for four weeks. Each session lasted 30-40 minutes and included: Lower 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 |
Structured Moderate-Intensity Resistance Training
Participants maintained their usual daily routines without structured exercise intervention.
|
|
No Intervention: CONTROL
Participants maintained their usual daily routines without structured exercise intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Thickness
Time Frame: 4 weeks
|
Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hepatic Fat Density
Time Frame: 4 weeks
|
Measurement: CT attenuation (Hounsfield Units) Single ROI in segment VIII
|
4 weeks
|
|
SF-12 Physical Health Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
|
SF-12 Mental Health Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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