Inspiratory Muscle Training in Patients With End Stage Renal Failure

NCT ID: NCT01347775

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Renal Failure; Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham inspiratory muscle training (URES HS730)

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

Inspiratory muscle training (URES HS730)

Intervention Type: 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

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Threshold at IMT device URES HS730, Respironics; Threshold at IMT device URES HS730, Respironics

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

The University of Queensland

Principal Investigators

Jennifer D Paratz, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

Royal Brisbane & Womens Hospital

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

IMTRF-06001

Identifier Type: -

Identifier Source: org_study_id