Inspiratory Muscle Training in Patients With End Stage Renal Failure
1 other identifier
interventional
48
1 country
1
Brief Summary
This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 29, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMay 4, 2011
May 1, 2011
4 years
April 29, 2011
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal inspiratory pressure (MIP)
American Thoracic Society standards
Change between baseline (enrolment) and 6 weeks
Secondary Outcomes (1)
Frenchay activities index
Change between baseline (enrolment) and 6 weeks
Study Arms (2)
Sham inspiratory muscle training
SHAM COMPARATORPatients 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
EXPERIMENTALInspiratory 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
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- documented chronic renal failure
- attending either haemodialysis or pre-dialysis clinic
- age 18
- English speaking
- no prior experience with inspiratory training devices.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brisbane & Womens Hospital
Brisbane, Queensland, 4069, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer D Paratz, PhD
The University of Queensland
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 4, 2011
Study Start
December 1, 2007
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
May 4, 2011
Record last verified: 2011-05