Inspiratory Muscle Training in Patients With End Stage Renal Failure

Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Renal Failure; Chronic Renal Insufficiency
• Intervention / Treatment: Device: Sham inspiratory muscle training (URES HS730); Device: Inspiratory muscle training (URES HS730)

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4069
      • Royal Brisbane & Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham inspiratory muscle training; 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.	Device: Sham inspiratory muscle training (URES HS730); Subjects in the control group underwent sham training, using the same device with the diaphragm removed, thus providing no resistance. They were not given frequency or duration but told to use the device when desired.; Other Names: Threshold at IMT device URES HS730, Respironics
Experimental: Inspiratory muscle training; 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	Device: Inspiratory muscle training (URES HS730); 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; Other Names: Threshold at IMT device URES HS730, Respironics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory pressure (MIP)	American Thoracic Society standards	Change between baseline (enrolment) and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frenchay activities index	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	Change between baseline (enrolment) and 6 weeks

Collaborators and Investigators

• Sponsor: The University of Queensland
• Investigators: Principal Investigator: Jennifer D Paratz, PhD, The University of Queensland

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: May 3, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Renal failure; Resistance training; Respiratory muscles
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: IMTRF-06001