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Inspiratory Muscle Training in Patients With End Stage Renal Failure

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347775
Enrollment
48
Registered
2011-05-04
Start date
2007-12-31
Completion date
2012-02-29
Last updated
2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Insufficiency, Renal Failure

Keywords

Renal failure, Respiratory muscles, Resistance training

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.

Interventions

DEVICEInspiratory 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

DEVICESham 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.

Sponsors

The University of Queensland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Maximal inspiratory pressure (MIP)Change between baseline (enrolment) and 6 weeksAmerican Thoracic Society standards

Secondary

MeasureTime frameDescription
Frenchay activities indexChange between baseline (enrolment) and 6 weeksThe 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026