Effect of Inspiratory Muscle Training on Diaphragm and Ab-dominal Wall Muscle Thickness With Fatty Liver Density in Elderly Women: A Randomized Controlled Trial

NCT07168733 | Completed DMC

• 2 other identifiers: 2025/2meeting date February 20, 2025
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Post-menopausal estrogen decline is considered a contributing factor to sarcopenia, and inspiratory muscle training (IMT) may provide benefits in this demo-graphic. This study examined the impact of a four-week IMT program on diaphragm thickness, abdominal wall muscle thickness (AWMT; transversus abdominis, internal oblique, and external oblique), and liver fat percentage in healthy elderly women. Methods: Twenty-six women aged 60-80 years were randomly assigned to an IMT group (n = 13) or a control group (n = 13). The IMT group used the PowerBreathe® Classic device at 40% of maximal inspiratory pressure (MIP), with weekly increments of 10%. Training was performed twice daily, five days per week, with 30 breathing cycles per session (60 per day). The control group maintained their usual routines. AWMT, diaphragm thickness (DT), and fatty liver density (FLD) were measured by a radiologist before and after the intervention.

Conditions

Perceived Recovery

Keywords

elderly women; health; exercise; aging; inspiratory muscle training

Outcome Measures

Primary Outcomes (3)

• pre-training

  Assessments were performed for all participants in both groups 4 weeks before and after treatment. These parameters were assessed using pre- and post-test measurements and compared between the IMT group and the control group Diaphragm Thickness (DT) * Mid-diaphragm thickness (MDT) * Posterior diaphragm thickness (PDT)

  4 week

• pre-training

  Assessments were performed for all participants in both groups 4 weeks before and after treatment. These parameters were assessed using pre- and post-test measurements and compared between the IMT group and the control group -Fatty Liver Density (FLD)

  4 Week

• pre-training

  Assessments were performed for all participants in both groups 4 weeks before and after treatment. These parameters were assessed using pre- and post-test measurements and compared between the IMT group and the control group Abdominal Wall Muscle Thickness (AWMT) * Right abdominal wall muscle thickness (RAWMT) * Left abdominal wall muscle thickness (LAWMT)

  4 week

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

Inspiratory muscle training group (IMT n:13) IMT was performed using the POWERbreathe® device (POWER® Breathe Classic, IMT Technologies Ltd., Birmingham, UK). The POWERbreathe® device is a pressure-threshold IMT device that provides resistance during inhalation. The user breathes in through a mouthpiece against an adjustable spring-loaded valve, which opens only when the inspiratory pressure exceeds the set threshold, thereby strengthening the inspiratory muscles over time (Kowalski \& Klusiewicz, 2023). Following a one-week familiarization period, the IMT protocol was performed twice daily (morning and evening), five days per week, for four weeks. Each session consisted of 30 breathing cycles, resulting in a total of 60 cycles per day. Prior to training, the device resistance was calibrated to 40% of each participant's maximal inspiratory pressure (MIP), as reported by Çelikel et al. (2025) to promote increases in muscle size and thickness. MIP was reassessed weekly and resistance was

Device: Inspiratory muscle training; Other: Control

CONTROL

NO INTERVENTION

The research group (Control Group (CG) (n:13)

Interventions

Inspiratory muscle training DEVICE

The POWERbreathe® device is a pressure-threshold IMT device that provides resistance during inhalation. The user breathes in through a mouthpiece against an adjustable spring-loaded valve, which opens only when the inspiratory pressure exceeds the set threshold, thereby strengthening the inspiratory muscles over time. Following a one-week familiarization period, the IMT protocol was performed twice daily (morning and evening), five days per week, for four weeks. Each session consisted of 30 breathing cycles, resulting in a total of 60 cycles per day. Prior to training, the device resistance was calibrated to 40% of each participant's maximal inspiratory pressure (MIP), as reported by Çelikel et al. (2025) to promote increases in muscle size and thickness. MIP was reassessed weekly and resistance was increased by 10%; progression was paused if participants experienced excessive strain.

Inspiratory muscle training

Control OTHER

The group that continues with their normal daily routines

Inspiratory muscle training

Eligibility Criteria

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

You may qualify if:

• were defined as women aged 60-80 years (post-menopausal), who were independent in activities of daily living,
• demonstrated adequate cognitive function to follow instructions,
• had no musculoskeletal injury within the previous six months,
• were non-smokers,
• had routine thoracic or abdominal CT images obtained for clinical indications and used in this study.

You may not qualify if:

• included having uncontrolled cardiovascular or pulmonary disease such as heart failure or COPD/asthma exacerbation,
• uncontrolled hypertension, diagnosed chronic liver disease,
• acute respiratory infection within the last four weeks,
• participation in structured respiratory or resistance training within the last six months,
• recent thoracoabdominal surgery or hernia, use of medications known to affect muscle or liver metabolism such as systemic corticosteroids, anabolic agents, or hepatotoxic drugs,
• severe orthopedic or neurological conditions limiting mobility, or refusal to participate.

Sponsors & Collaborators

• Gümüşhane Universıty: lead

Study Sites (1)

Gumushane Univetsity

Kelkit, Gümüşhane Province, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

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: Women aged 60-80 were invited to attend the laboratory on three separate occa-sions. During the initial visit, the experimental procedures were introduced and tested. Prior to the commencement of the experiment, each participant was furnished with a comprehensive explanation of the IMT procedure. Each participant underwent a week-long trial period, during which they were closely monitored by an experienced physiotherapist. The trial period involved the use of a respiratory muscle training device that was customised to meet the specific requirements of each participant. During the second visit, a series of pre-training measurements were taken and recorded. The tests included evaluations of AWMT, diaphragm thickness (DT), and (FLD), all of which were conducted under the supervision of a radiologist. After the four-week IMT training programme, final measurements were obtained during the final visit

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 11, 2025
• Study Start: June 5, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 5, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

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

Locations

TU (1)