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Completed

NCT Number: NCT00426881

Brain Power: Resistance Training and Cognitive Function

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.

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Key information

Conditions

Healthy Behavior Motor Activity

Age range

65 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health Research Institute Research Pavilion, Vancouver, British Columbia, Canada

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About this study

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:

  • Are changes in cortical activation associated with RT-induced changes in executive function?
  • Are RT-induced improvements in executive function associated with lowered physiological fall risk?
  • 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 (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sedentary (less than twice weekly exercising) women aged 65-75 years old without conditions restricting them from exercising.

Treatment and study plan

Exercise Training

Behavioral

Twice weekly resistance training for 52 weeks.

Primary outcomes

  1. Cognitive Performance of Executive Function

    Time frame: 12 months

Secondary outcomes

  1. Functional MRI and physiological falls risk

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Michael Smith Foundation for Health Research

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 25, 2007
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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