Inspiratory Muscle Training in Patients With End Stage Renal Failure
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2011 | ||||
| Last Updated Date | May 3, 2011 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Maximal inspiratory pressure (MIP) [ Time Frame: Change between baseline (enrolment) and 6 weeks ] [ Designated as safety issue: No ] American Thoracic Society standards |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01347775 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Inspiratory Muscle Training in Patients With End Stage Renal Failure | ||||
| Official Title ICMJE | Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial | ||||
| Brief Summary | This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | February 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01347775 | ||||
| Other Study ID Numbers ICMJE | IMTRF-06001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Jennifer Paratz, The University of Queensland | ||||
| Study Sponsor ICMJE | The University of Queensland | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Queensland | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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