Brain Power: Resistance Training and Cognitive Function
| Tracking Information | |||||
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| First Received Date ICMJE | January 23, 2007 | ||||
| Last Updated Date | September 28, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cognitive Performance of Executive Function [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Cognitive Performance of Executive Function | ||||
| Change History | Complete list of historical versions of study NCT00426881 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Functional MRI and physiological falls risk [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Functional MRI and physiological falls risk | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brain Power: Resistance Training and Cognitive Function | ||||
| Official Title ICMJE | The Effect of Resistance Training on Cognitive Performance, Cortical Plasticity, and Fall Risk in Women Aged 65-75 Years Old: A 12-Month RCT | ||||
| Brief Summary | Primary Objectives: 1. To ascertain whether a 12-month, twice-weekly or once-weekly resistance training (RT) program will significantly improve executive function in community-dwelling women aged 65 to 75 years old compared with a 12-month, twice-weekly stretch and relax (S & R) program (shame exercise). We will assess executive function by standard neuropsychological tests. Secondary Objectives:
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| Detailed Description | Primary Research Question: Does resistance training (RT) significantly improve cognitive function, specifically executive function in older women with a Mini-Mental State Examination (MMSE) score equal to or greater than 24 (i.e., cognitively intact) compared with a stretch & relax (S & R; control) program? Secondary Research Questions:
RESEARCH PLAN: Study Design: A 12-month, single-blinded, randomized controlled trial. Participants: 155 cognitively-intact (i.e., MMSE score > 24), right-handed, sedentary community-dwelling women, aged 65 to 75 years. Measurement: Measurements will take place at baseline, six month, and trial completion. Standard neuropsychological testing and physiological fall risk assessment will occur at all three measurement sessions. A subset of the participants (20 from each experimental group) will undergo fMRI assessment at baseline and trial completion only. Exercise Classes: Participants will be randomized to a 12-month, twice-weekly or once-weekly RT program or stretch & relax program (control). All exercises will be offered at a Vancouver YMCA with whom we have partnered previously. Sample Size Justification: The sample size of 50 per experimental group (i.e., N = 155) is based on the primary end point of this study, cognitive performance of executive function. SUMMARY: Falls are a major challenge for the senior population. To date, no intervention has significantly reduced falls among those with cognitive impairment. Our immediate primary goal is to test whether RT can improve cognitive performance of executive function; impaired executive function are associated with injurious falls. If this proposed exercise trial proves successful, the RT intervention will be trialed in the future in a larger study powered for falls. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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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 | 155 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 65 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00426881 | ||||
| Other Study ID Numbers ICMJE | H06-03216, ORSIL 06-1737, ORSIL 05-6933 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of British Columbia | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | Michael Smith Foundation for Health Research | ||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | September 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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