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HealthyNCT00426881

Brain Power: Resistance Training and Cognitive Function

A study testing Exercise Training in people with Healthy, run by University of British Columbia at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
2 sitesCanada
Study dates
Jan 2007to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • YMCA

    Vancouver, British Columbia, V5Y 2Z5

  • Vancouver Coastal Health Research Institute Research Pavilion

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

About this study

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

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.
Read more

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.
Read the 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:

  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 (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.

Conditions
Healthy
Being tested
Exercise Training
Keywords
Exercise, Resistance training
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00426881
Study groupRoleWhat they receive
1ExperimentalTwice weekly resistance training for 52 weeks.
Receives: Behavioral: Exercise Training
2ExperimentalOnce weekly resistance training for 52 weeks.
Receives: Behavioral: Exercise training
3ExperimentalTwice weekly balance and tone training for 52 weeks.
Receives: Behavioral: Exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Performance of Executive Function

    Measured: 12 months

Secondary outcomes (1)

  1. Functional MRI and physiological falls risk

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00426881
Sponsor's protocol ID
H06-03216
Other IDs
ORSIL 06-1737, ORSIL 05-6933
Status last verified
Oct 2017
First submitted
23 Jan 2007
Last updated
4 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bolandzadeh N, Tam R, Handy TC, Nagamatsu LS, Hsu CL, Davis JC, Dao E, Beattie BL, Liu-Ambrose T. Resistance Training and White Matter Lesion Progression in Older Women: Exploratory Analysis of a 12-Month Randomized Controlled Trial. J Am Geriatr Soc. 2015 Oct;63(10):2052-60. doi: 10.1111/jgs.13644. Epub 2015 Oct 12.

    PubMed 26456233

  • Davis JC, Nagamatsu LS, Hsu CL, Beattie BL, Liu-Ambrose T. Self-efficacy is independently associated with brain volume in older women. Age Ageing. 2012 Jul;41(4):495-501. doi: 10.1093/ageing/afs029. Epub 2012 Mar 21.

    PubMed 22436405

  • Nagamatsu LS, Hsu CL, Handy TC, Liu-Ambrose T. Functional neural correlates of reduced physiological falls risk. Behav Brain Funct. 2011 Aug 16;7:37. doi: 10.1186/1744-9081-7-37.

    PubMed 21846395

  • Davis JC, Marra CA, Robertson MC, Najafzadeh M, Liu-Ambrose T. Sustained economic benefits of resistance training in community-dwelling senior women. J Am Geriatr Soc. 2011 Jul;59(7):1232-7. doi: 10.1111/j.1532-5415.2011.03474.x. Epub 2011 Jun 30.

    PubMed 21718265

  • Davis JC, Marra CA, Liu-Ambrose TY. Falls-related self-efficacy is independently associated with quality-adjusted life years in older women. Age Ageing. 2011 May;40(3):340-6. doi: 10.1093/ageing/afr019. Epub 2011 Mar 24.

    PubMed 21436152

  • Davis JC, Marra CA, Beattie BL, Robertson MC, Najafzadeh M, Graf P, Nagamatsu LS, Liu-Ambrose T. Sustained cognitive and economic benefits of resistance training among community-dwelling senior women: a 1-year follow-up study of the Brain Power study. Arch Intern Med. 2010 Dec 13;170(22):2036-8. doi: 10.1001/archinternmed.2010.462. No abstract available.

    PubMed 21149764

  • Liu-Ambrose T, Davis JC, Nagamatsu LS, Hsu CL, Katarynych LA, Khan KM. Changes in executive functions and self-efficacy are independently associated with improved usual gait speed in older women. BMC Geriatr. 2010 May 19;10:25. doi: 10.1186/1471-2318-10-25.

    PubMed 20482830

  • Davis JC, Marra CA, Najafzadeh M, Liu-Ambrose T. The independent contribution of executive functions to health related quality of life in older women. BMC Geriatr. 2010 Apr 1;10:16. doi: 10.1186/1471-2318-10-16.

    PubMed 20359355

  • Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.

    PubMed 20101012

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training in people with Healthy, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Performance of Executive Function (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00426881, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.

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