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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

April 29, 2011
May 3, 2011
December 2007
December 2011   (final data collection date for primary outcome measure)
Maximal inspiratory pressure (MIP) [ Time Frame: Change between baseline (enrolment) and 6 weeks ] [ Designated as safety issue: No ]
American Thoracic Society standards
Same as current
Complete list of historical versions of study NCT01347775 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Inspiratory Muscle Training in Patients With End Stage Renal Failure
Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Renal Failure
  • Chronic Renal Insufficiency
  • 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
  • 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
  • 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.
    Intervention: Device: Sham inspiratory muscle training (URES HS730)
  • 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
    Intervention: Device: Inspiratory muscle training (URES HS730)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
February 2012
December 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01347775
IMTRF-06001
Yes
Dr Jennifer Paratz, The University of Queensland
The University of Queensland
Not Provided
Principal Investigator: Jennifer D Paratz, PhD The University of Queensland
The University of Queensland
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP