Inspiratory Muscle Training in Patients With End Stage Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by The University of Queensland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT01347775
First received: April 29, 2011
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Renal Failure
Chronic Renal Insufficiency
Device: Inspiratory muscle training (URES HS730)
Device: Sham inspiratory muscle training (URES HS730)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Queensland:

Primary Outcome Measures:
  • Maximal inspiratory pressure (MIP) [ Time Frame: Change between baseline (enrolment) and 6 weeks ] [ Designated as safety issue: No ]
    American Thoracic Society standards


Secondary Outcome Measures:
  • Frenchay activities index [ Time Frame: Change between baseline (enrolment) and 6 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 48
Study Start Date: December 2007
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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.
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.
Other Name: Threshold at IMT device URES HS730, Respironics
Experimental: 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
Device: 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
Other Name: Threshold at IMT device URES HS730, Respironics

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347775

Locations
Australia, Queensland
Royal Brisbane & Womens Hospital
Brisbane, Queensland, Australia, 4069
Sponsors and Collaborators
The University of Queensland
Investigators
Principal Investigator: Jennifer D Paratz, PhD The University of Queensland
  More Information

No publications provided

Responsible Party: Dr Jennifer Paratz, The University of Queensland
ClinicalTrials.gov Identifier: NCT01347775     History of Changes
Other Study ID Numbers: IMTRF-06001
Study First Received: April 29, 2011
Last Updated: May 3, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Queensland:
Renal failure
Respiratory muscles
Resistance training

Additional relevant MeSH terms:
Respiratory Aspiration
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014