Overview

This trial is active, not recruiting.

Conditions renal failure, chronic renal insufficiency
Treatments inspiratory muscle training (ures hs730), sham inspiratory muscle training (ures hs730)
Phase phase 4
Sponsor The University of Queensland
Start date December 2007
End date December 2011
Trial size 48 participants
Trial identifier NCT01347775, IMTRF-06001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
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.
sham inspiratory muscle training (ures hs730) Threshold at IMT device URES HS730, Respironics
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.
(Experimental)
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
inspiratory muscle training (ures hs730) Threshold at IMT device URES HS730, Respironics
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 Outcomes

Measure
Maximal inspiratory pressure (MIP)
time frame: Change between baseline (enrolment) and 6 weeks

Secondary Outcomes

Measure
Frenchay activities index
time frame: Change between baseline (enrolment) and 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
Principal investigator Jennifer D Paratz, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by The University of Queensland.