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 (RT-DIA-OLDER)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane
-
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Tyrkia (Türkiye), 29600
- Gumushane Univetsity
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Ingen inngripen: CONTROL
Participants maintained their usual daily routines without structured exercise intervention. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diaphragm Thickness
Tidsramme: 4 weeks
|
Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration. |
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hepatic Fat Density
Tidsramme: 4 weeks
|
Measurement: CT attenuation (Hounsfield Units) Single ROI in segment VIII |
4 weeks
|
|
SF-12 Physical Health Score
Tidsramme: 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
Tidsramme: 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
|
|
Six-minute walk test (6MWT)
Tidsramme: 4 WEEK
|
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. |
4 WEEK
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-95674917-108.99-181733
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .