Inspiratory Muscle Training in Patients With End Stage Renal Failure

The University of Queensland

Status and phase: Unknown; Phase 4

Conditions: Renal Failure; Chronic Renal Insufficiency

Treatments: Device: Inspiratory muscle training (URES HS730); Device: Sham inspiratory muscle training (URES HS730)

Study type: Interventional

Funder types: Other

Identifiers

NCT01347775

IMTRF-06001

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Sham inspiratory muscle training

Sham Comparator group

Description:

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.

Treatment:

Device: Sham inspiratory muscle training (URES HS730)

Inspiratory muscle training

Experimental group

Description:

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

Treatment:

Device: Inspiratory muscle training (URES HS730)