NCT07449767

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

February 27, 2026

Last Update Submit

September 25, 2026

Conditions

Older MenQuality of LifeFatty LiverAgingResistance Training

Keywords

Older menQuality of lifeFatty liverDiaphragm thicknessResistance trainingAging

Outcome Measures

Primary Outcomes (1)

  • Diaphragm Thickness

    Diaphragm thickness measured in millimeters using non-contrast computed tomography at full inspiration.

    4 weeks

Secondary Outcomes (4)

  • Hepatic Fat Density

    4 weeks

  • SF-12 Physical Health Score

    4 weeks

  • SF-12 Mental Health Score

    4 weeks

  • Six-minute walk test (6MWT)

    4 WEEK

Study Arms (2)

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

Behavioral: Resistance Training Group (RT)Other: Control

CONTROL

NO INTERVENTION

Participants maintained their usual daily routines without structured exercise intervention.

Interventions

Resistance Training Group (RT)BEHAVIORAL

Structured Moderate-Intensity Resistance Training

Resistance Training Group (RT)
ControlOTHER

Participants maintained their usual daily routines without structured exercise intervention.

Resistance Training Group (RT)

Eligibility Criteria

Age60 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gumushane Univetsity

Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants were not blinded to group allocation because of the nature of the exercise intervention. The personnel delivering the intervention were also aware of group allocation. Outcome assessors, including the radiologist responsible for CT-based diaphragm thickness assessment, and the statistician were blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC. PROF.

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

March 10, 2026

Primary Completion

April 25, 2026

Study Completion

May 30, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)