Inspiratory Muscle Training in Patients With End Stage Renal Failure

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

Detailed Description
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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.

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

Conditions
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Renal Failure, Chronic Renal Insufficiency

Intervention / Treatment
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* Device: Inspiratory muscle training (URES HS730)
* Device: Sham inspiratory muscle training (URES HS730)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham inspiratory muscle training<br>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. | Device: Sham inspiratory muscle training (URES HS730)<br>* 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.<br>* Other names: Threshold at IMT device URES HS730, Respironics;|
| Experimental: Inspiratory muscle training<br>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 | Device: Inspiratory muscle training (URES HS730)<br>* 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<br>* Other names: Threshold at IMT device URES HS730, Respironics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory pressure (MIP) | American Thoracic Society standards | Change between baseline (enrolment) and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal failure, Respiratory muscles, Resistance training