Inspiratory Muscle Training in Patients With End Stage Renal Failure

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347775
• Other study ID #: IMTRF-06001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 29, 2011
• Last updated: May 3, 2011
• Start date: December 2007
• Est. completion date: February 2012

Study information

• Verified date: May 2011
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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
• 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.

Locations

Country	Name	City	State
Australia	Royal Brisbane & Womens Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory pressure (MIP)	American Thoracic Society standards	Change between baseline (enrolment) and 6 weeks	No
Secondary	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	No