Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426881
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2007-01-23
Brief Title:
Brain Power Resistance Training and Cognitive Function
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Effect of Resistance Training on Cognitive Performance Cortical Plasticity and Fall Risk in Women Aged 65-75 Years Old A 12-Month RCT
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 To describe the neural mechanisms that underpin the observed changes in executive function associated with a 12-month twice-weekly or once-weekly RT training by using functional magnetic resonance imaging fMRI
2 To investigate whether RT-induced changes in executive function are independently associated with changes in physiological fall risk profile
3 To investigate the dose response of RT resistance training on bone health as measured by dual energy x-ray and peripheral quantitative computed tomography
4 To conduct a one-year follow-up after the formal cessation of the resistance training programs to determine the persisting effect of resistance training on cognitive performance cortical plasticity physiological falls risk and bone health
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
1 To describe the neural mechanisms that underpin the observed changes in executive function associated with a 12-month twice-weekly or once-weekly RT training by using functional magnetic resonance imaging fMRI
2 To investigate whether RT-induced changes in executive function are independently associated with changes in physiological fall risk profile
3 To investigate the dose response of RT resistance training on bone health as measured by dual energy x-ray and peripheral quantitative computed tomography
4 To conduct a one-year follow-up after the formal cessation of the resistance training programs to determine the persisting effect of resistance training on cognitive performance cortical plasticity physiological falls risk and bone health
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 ie cognitively intact compared with a stretch relax S R control program
Secondary Research Questions
1 Are changes in cortical activation associated with RT-induced changes in executive function
2 Are RT-induced improvements in executive function associated with lowered physiological fall risk
3 Is there a dose-response on bone health with RT resistance training
RESEARCH PLAN
Study Design A 12-month single-blinded randomized controlled trial Participants 155 cognitively-intact ie 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 ie 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
Secondary Research Questions
1 Are changes in cortical activation associated with RT-induced changes in executive function
2 Are RT-induced improvements in executive function associated with lowered physiological fall risk
3 Is there a dose-response on bone health with RT resistance training
RESEARCH PLAN
Study Design A 12-month single-blinded randomized controlled trial Participants 155 cognitively-intact ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ORSIL 05-6933 | None | None | None |
| ORSIL 06-1737 | None | None | None |