Inspiratory Muscle Training in Patients With End Stage Renal Failure

Phase 4

• Conditions: Renal Failure; Chronic Renal Insufficiency
• Interventions: Device: Sham inspiratory muscle training (URES HS730); Device: Inspiratory muscle training (URES HS730)

• Registration Number: NCT01347775
• Lead Sponsor: The University of Queensland

Brief Summary

This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.

Detailed Description

Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.

This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.

Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2011-04-29
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-03
• Last Update Submitted: 2011-05-03
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04
• Primary Completion: 2011-12
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• documented chronic renal failure
• attending either haemodialysis or pre-dialysis clinic
• age 18
• English speaking
• no prior experience with inspiratory training devices.

Exclusion Criteria

• lung collagen disorders
• renal diseases associated with autoimmune pulmonary diseases
• current pleural effusion
• pulmonary oedema
• decreased conscious level
• behavioural disturbances
• unable or refused to give consent
• taking medications that influence respiratory muscle function (e.g. steroids or cyclophosphamide)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham inspiratory muscle training	Sham inspiratory muscle training (URES HS730)	Patients in the sham group used the threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), with the diaphragm removed.
Inspiratory muscle training	Inspiratory muscle training (URES HS730)	Inspiratory muscle training will be by a threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), a commercially available spring-loaded inspiratory muscle training device. It will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks

Primary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure (MIP)	Change between baseline (enrolment) and 6 weeks	American Thoracic Society standards

Secondary Outcome Measures

Name	Time	Method
Frenchay activities index	Change between baseline (enrolment) and 6 weeks	The Frenchay activities index is a measure of instrumental activities of everyday living.The FAI assesses a broad range of activities associated with everyday life including social and family participation

Trial Locations

Locations (1)

Royal Brisbane & Womens Hospital; 🇦🇺 Brisbane, Queensland, Australia