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Inspiratory Muscle Training in Patients With End Stage Renal Failure

Primary Purpose

Renal Failure, Chronic Renal Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Inspiratory muscle training (URES HS730)
Sham inspiratory muscle training (URES HS730)
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Renal failure, Respiratory muscles, Resistance training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Royal Brisbane & Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham inspiratory muscle training

Inspiratory muscle training

Arm 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.

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

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure (MIP)
American Thoracic Society standards

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2011
Last Updated
May 3, 2011
Sponsor
The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT01347775
Brief Title
Inspiratory Muscle Training in Patients With End Stage Renal Failure
Official Title
Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Queensland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic Renal Insufficiency
Keywords
Renal failure, Respiratory muscles, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham inspiratory muscle training
Arm Type
Sham Comparator
Arm 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.
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training (URES HS730)
Other Intervention Name(s)
Threshold at IMT device URES HS730, Respironics
Intervention Description
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
Intervention Name(s)
Sham inspiratory muscle training (URES HS730)
Other Intervention Name(s)
Threshold at IMT device URES HS730, Respironics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure (MIP)
Description
American Thoracic Society standards
Time Frame
Change between baseline (enrolment) and 6 weeks
Secondary Outcome Measure Information:
Title
Frenchay activities index
Description
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
Time Frame
Change between baseline (enrolment) and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D Paratz, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brisbane & Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4069
Country
Australia

12. IPD Sharing Statement

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Inspiratory Muscle Training in Patients With End Stage Renal Failure

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