Effects of Exercise in People With Paraplegia
| Tracking Information | |||||
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| First Received Date ICMJE | September 15, 2010 | ||||
| Last Updated Date | July 5, 2012 | ||||
| Start Date ICMJE | October 2008 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Global cardiovascular disease risk score [ Time Frame: 4 visits over 9 months ] [ Designated as safety issue: No ] Global cardiovacular disease risk will be generated by evaluating blood metabolism in the fasting and fed state for inflammatory disease markers including total cholesterol: high density lipoprotein ratio (TC: HDL ratio), post-prandial lipemia (PPL), whole body fat oxidation (WBFO), insulin resistance, and inflammatory mediators. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01203150 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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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 | Effects of Exercise in People With Paraplegia | ||||
| Official Title ICMJE | Exercise Treatment of Obesity-Related Secondary Conditions in Adults With Paraplegia | ||||
| Brief Summary | This hypothesis-driven study will investigate effects of physical activity with or without a nutrient supplement known to increase body lean mass in adults with chronic paraplegia who have clusters of obesity and obesity-related secondary complications. |
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| Detailed Description | Obesity and obesity-related secondary complications are pandemic health hazards that are highly prevalent among persons with spinal cord injuries (SCI). Accumulation of body fat disposes persons with SCI to accelerated endocrine and cardiovascular diseases, as well as pain, functional decline, and diminished health-related quality of life (HRQoL). While use of combined resistance and endurance exercise by persons without disability can remedy many of the problems associated with these disorders, their widespread use for persons with spinal cord injuries (SCI) must first satisfy scientific burdens of effectiveness. The investigators have adopted the term "obesity-related secondary complications" to describe accumulation of body fat clustering with other secondary CVD risks, while recognizing that a threshold criterion for diagnosis of obesity in persons with SCI remains ill-defined. For purposes of this proposal, the "-related" part of the term confers physical deconditioning, hypertension, fasting dyslipidemia, post-prandial lipemia (PPL), and impaired insulin sensitivity, all of which have been reported in persons with SCI. Contextualized, any of these risks occurring independently or in clusters would be cause for immediate therapeutic lifestyle intervention (TLI), if not frank medical treatment. Given our early understanding of effective treatments for these risks, any improvement in their severity would be CVD risk-reducing and thus life-benefiting and function-preserving. The investigators expect that the research findings will improve the understanding of risks for obesity and obesity-related secondary complications so that future interventions can be better targeted, identify an exercise intervention that can attend to current health risks, clarify whether nutrient supplementation improves risk-lessening benefits of exercise, identify exercise timing and intensities that best enhance fat utilization, and expand the understanding of the interrelated nature of risk factors after SCI. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Spinal Cord Injury | ||||
| Intervention ICMJE | Other: Exercise
CRT will occur 3 times per week for 26 weeks. Each training session will last approximately 40-45 minutes and employ resistance training (weight lifting) and high-speed, low intensity endurance activities (arm cranking) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
Other Name: Circuit Resistance Training (CRT) |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01203150 | ||||
| Other Study ID Numbers ICMJE | TMP-MN-006 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mark S. Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis | ||||
| Study Sponsor ICMJE | University of Miami | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Miami | ||||
| Verification Date | November 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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