Effects of Intradialytic Inspiratory Muscle Training on Functional Capacity in Hemodialysis Patients

NCT07094347 | Not Yet Recruiting

• 1 other identifier: KA24/416
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a need for long-term sustainable studies that will increase the potential health benefits in hemodialysis patients. Inspiratory muscle training, one of the recommended treatments to increase exercise capacity and quality of life during dialysis treatment in people with chronic renal failure, is a method that can be applied intradialytically, in addition to being easy to apply, cheap and sustainable. It improves functional capacity by increasing respiratory muscle strength. In this context, our study aims to investigate the effects of inspiratory muscle training on functional parameters and on hemodialysis patients with a personalized portable device and to add it to the literature.

Conditions

Hemodialysis

Keywords

powerbreathe

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  The respiratory muscle strength measuring device Power Breathe (Power Breathe, K5, HaB International Ltd England) will be used to assess inspiratory muscle strength. During the assessment, the patient will be asked to sit in a chair with back support and no arm support, with shoulders relaxed, and a nose clip will be used. Patients will be asked to take a deep breath through the device placed in their mouth. The inspiratory force index (S-index) obtained as a result of the measurement will be recorded.

  The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).

Secondary Outcomes (1)

• Exercise Capacity Assessment

  The individuals participating in the study will be evaluated twice: before the application (week 0) and after the application (after 12 weeks).

Study Arms (2)

Inspiratory Muscle Training Group

EXPERIMENTAL

The individuals in the study group will be given a 12-week respiratory muscle training after the first assessment and training session. The Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device's mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

Device: inspiratory muscle training

control

NO INTERVENTION

At the beginning of the study after the first assessment, the control group will be given a training session lasting approximately 30 minutes. During the training session, participants will be given training on bronchial hygiene techniques and respiratory control, pursed lip breathing, diaphragmatic breathing exercises and thoracic expansion exercises that will improve lung health. Individuals in the control group will only receive the training session after the assessment.

Interventions

inspiratory muscle training DEVICE

Powerbreathe® threshold resistance loading device (POWERbreathe, HaB International) will be used for this training program that strengthens the inspiratory muscles. The PowerBreathe® device is a threshold device that creates resistance to inspiration. This resistance is created by the spring tension in the device mechanism. The device has a mechanism that is adjusted according to 9 different levels in its mechanism specific to the individuals using it.

Inspiratory Muscle Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being on hemodialysis for at least 6 months
• Being on hemodialysis for 4 hours, 3 days a week
• Not having had a transplant
• Being able to continue sitting and standing
• Being able to walk without assistance
• Being willing to participate in the study

You may not qualify if:

• Individuals with communication and/or cognitive problems that are unable to fulfill the assessment and treatment requirements
• Patients with uncontrolled cardiac, pulmonary or other systemic diseases

Sponsors & Collaborators

• Baskent University: lead

Related Publications (1)

• Katayifci N, Huzmeli I, Iri S D, Turgut FH. Effects of different inspiratory muscle training protocols on functional exercise capacity and respiratory and peripheral muscle strength in patients with chronic kidney disease: a randomized study. BMC Nephrol. 2024 May 29;25(1):184. doi: 10.1186/s12882-024-03610-1.

  PMID: 38811888 RESULT

Central Study Contacts

yasemin kavuncubaşı genç, phd canditate

CONTACT

+905321764598; ykavuncubasigenc@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized controlled trial.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 30, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share