Older MenRT-DIA-OLDERNCT07449767
Effects of Resistance-Based Multicomponent Training Incorporating Respiratory Exercise on Diaphragm Thickness, Hepatic Attenuation, and Quality of Life in Healthy Older Men: A Randomized Controlled Trial
A study testing Resistance Training Group (RT) in people with Older Men and Quality of Life, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Older Men, Quality of Life, Fatty Liver
- What is being tested?
- Resistance Training Group (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gumushane Univetsity
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, 29600
About this study
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.
Read the 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.
- Conditions
- Older Men, Quality of Life, Fatty Liver, Resistance Training, Aging
- Being tested
- Resistance Training Group (RT), Control
- Keywords
- Older men, Quality of life, Fatty liver, Diaphragm thickness, Resistance training, Aging
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training Group (RT)Behavioural
Structured Moderate-Intensity Resistance Training
ControlOther
Participants maintained their usual daily routines without structured exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Group (RT) | Experimental | 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 Receives: Behavioral: Resistance Training Group (RT); Other: Control |
| CONTROL | No intervention | Participants maintained their usual daily routines without structured exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness
Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.
Measured: 4 weeks
Secondary outcomes (4)
Hepatic Fat Density
Measurement: CT attenuation (Hounsfield Units) Single ROI in segment VIII
Measured: 4 weeks
SF-12 Physical Health Score
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.
Measured: 4 weeks
SF-12 Mental Health Score
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.
Measured: 4 weeks
Six-minute walk test (6MWT)
Functional exercise capacity was assessed using the 6-Minute Walk Test (6MWT) according to a standardised protocol based on established 6MWT recommendations. The test was performed on a flat, straight 30-m indoor corridor, with the course clearly marked at both ends. Participants were instructed to walk back and forth along the corridor for 6 min at a self-selected walking pace, with the objective of covering the greatest possible distance within the allotted time.
Measured: 4 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start10 Mar 2026
- Primary completion25 Apr 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coşkun YILMAZ, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449767
- Sponsor's protocol ID
- E-95674917-108.99-181733
- Acronym
- RT-DIA-OLDER
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance-Based Multicomponent Training Incorporating Respiratory Exercise on Diaphragm Thickness, Hepatic Attenuation, and Quality of Life in Healthy Older Men: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07449767
- Acronym / sponsor ID
- RT-DIA-OLDER / E-95674917-108.99-181733
- Conditions
- Older Men, Quality of Life, Fatty Liver, Resistance Training, Aging
- Keywords
- Older men, Quality of life, Fatty liver, Diaphragm thickness, Resistance training, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Group (RT) | Experimental | Behavioral: Resistance Training Group (RT), Other: ControlParticipants 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 |
| CONTROL | No intervention | –Participants maintained their usual daily routines without structured exercise intervention. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training Group (RT)Structured Moderate-Intensity Resistance Training | Behavioural | Resistance Training Group (RT) |
| ControlParticipants maintained their usual daily routines without structured exercise intervention. | Other | Resistance Training Group (RT) |
Primary outcome
Diaphragm Thickness
Time frame: 4 weeks
Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.
4 secondary outcomes
Hepatic Fat Density
Time frame: 4 weeks
SF-12 Physical Health Score
Time frame: 4 weeks
SF-12 Mental Health Score
Time frame: 4 weeks
Six-minute walk test (6MWT)
Time frame: 4 WEEK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Group (RT) in people with Older Men and Quality of Life, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickness (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.