Effect of Inspiratory Muscle Training on Diaphragm Muscle Thickness, Fatty Liver Density and Aerobic Capacity in Elderly Men: A Randomized Controlled Trial

NCT07193082 | Completed DMC

• 1 other identifier: 2025/0464
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate the effects of a 4-week inspiratory muscle training (IMT) program on diaphragm muscle thickness, fatty liver density, functional capacity, and quality of life in elderly men aged 60-80 years. Participants were randomized into an IMT group and a control group. Assessments included diaphragm thickness, fatty liver density (via CT), six-minute walk test (6MWT), and quality of life (SF-12).

Conditions

Aging; Inspiratory Muscle Weakness; Fatty Liver; Reduced Functional Capacity

Keywords

Aging; older women; exercise; gait; inspiratory muscle training; health

Outcome Measures

Primary Outcomes (2)

• fatty liver density

  Change in fatty liver density (CT measurement) from baseline to 4 weeks.

  4 weeks.

• Diaphragm thickness

  Change in diaphragm thickness (CT measurement) from baseline to 4 weeks.

  4 weeks.

Secondary Outcomes (2)

• 6MWT distance

  4 weeks.

• SF-12 Physical and Mental Component Scores

  4 weeks

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

Experimental (IMT Group): Inspiratory Muscle Training (POWERbreathe® device, twice daily, 30 breaths per session, 5 days/week, 4 weeks, resistance starting at 40% of MIP and increased weekly).

Device: Experimental Inspiratory Muscle Training (IMT Group); Device: Control Group: No inspiratory muscle training.

CONTROL

NO INTERVENTION

Control Group: No inspiratory muscle training.

Interventions

Experimental Inspiratory Muscle Training (IMT Group) DEVICE

Experimental (IMT Group): Inspiratory Muscle Training (POWERbreathe® device, twice daily, 30 breaths per session, 5 days/week, 4 weeks, resistance starting at 40% of MIP and increased weekly).

Inspiratory muscle training

Control Group: No inspiratory muscle training. DEVICE

Control Group: No inspiratory muscle training.

Inspiratory muscle training

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 60-80 years
• Healthy, without severe comorbidities
• Voluntary participation with informed consent

You may not qualify if:

• Known respiratory or cardiovascular disease
• Neurological or musculoskeletal disorders limiting participation
• Recent abdominal or thoracic surgery
• Inability to comply with training protocol

Sponsors & Collaborators

• Gümüşhane Universıty: lead

Study Sites (1)

Gumushane Univetsity

Gümüşhane, Kelkit, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatty Liver; Motor Activity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC. PROF.

Model Details: Experimental (IMT Group): Inspiratory Muscle Training (POWERbreathe® device, twice daily, 30 breaths per session, 5 days/week, 4 weeks, resistance starting at 40% of MIP and increased weekly). Control Group: No inspiratory muscle training.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 25, 2025
• Study Start: June 5, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 10, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)