Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

EXCEL: Exercise for Cognition and Everyday Living for Seniors With Memory Complaints

This study has been completed.
Sponsor:
Collaborator:
Pacific Alzheimer Research Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00958867
First received: August 11, 2009
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

Alzheimer's disease (AD) is a major health issue in Canada; it affects over 8% of the population aged over 65 years. Persons with AD have a reduced quality of life as they become dependent on others for activities of daily living (ADLs). This problem of loss of independence - functional dependence - is one focus of this grant application. It is projected that by 2020, Canada will have well over 10 million seniors with moderate to severe functional dependence. Functional dependence was the most significant contributor to an annual cost of dementia that had already reached $4 billion in the 1990s.

Mild cognitive impairment (MCI) is a well-recognized risk factor for both AD and functional dependence. Within the broader assessment of cognitive function, the literature suggests that executive functioning - the ability to concentrate, to attend selectively, to plan and strategize - is a robust cognitive predictor of functional status in seniors. Specifically, Royall and colleagues demonstrated executive functioning independently explained 43% of the functional status in community-dwelling seniors dementia. The researchers will investigate executive functioning in seniors with MCI.

Randomized trials of various exercise interventions have proven that exercise has many systemic benefits. Data are emerging that physical activity may improve cognition - specifically executive function - in healthy adults. The researchers' own pilot data suggest that resistance training in seniors may improve executive functioning as assessed by neuropsychological tests and neuro-imaging. However, at present the Cochrane Database of Systematic Reviews indicates there are insufficient published data to guide exercise prescription to prevent AD. In persons with MCI, no published studies have reported on whether physical activity can improve executive function, or delay its decline and thus, prevent or delay the onset of functional dependence (and later, dementia).

Therefore, among seniors with MCI, the researchers will investigate whether or not specific exercise prescription can: 1) provide absolute or relative improvement in cognitive function, particularly executive function; and 2) help maintain functional independence. This will facilitate the development of effective exercise-based strategies for the prevention of both cognitive and functional decline in the large population of seniors with MCI - people at greatly increased risk for AD.

The researchers' proposed research aims to ascertain whether a six-month, twice-weekly aerobic training (AT) program and a six-month, twice-weekly resistance training (RT) program, compared with a six-month, twice-weekly stretch & relax (S & R; control) program, will significantly improve cognition and functional status in community-dwelling women with MCI aged 70 years and older.

Primary Hypothesis:

At the end of six-month randomized trial, compared with the S & R program, both the AT and RT programs will significantly improve cognitive performance, as assessed by neuropsychological testing.

Secondary Hypotheses:

At the end of the six-month randomized trial, compared with the S & R program, participants of the AT and RT programs will:

  1. Demonstrate evidence of cortical plasticity by fMRI, such as increased activation in cortical regions responsible for item and relational memory; and
  2. Will significantly improve their everyday problem solving ability.

Condition Intervention
Mild Cognitive Impairment
Behavioral: Exercise program (AT)
Behavioral: Exercise training (RT)
Behavioral: Exercise training (S & R; control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Enhancing Cognition and Functional Independence in Senior Women With Mild Cognitive Impairment: A Randomized Trial of Aerobic vs. Resistance Training

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Cognitive performance after 3 and 6 months of training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Everyday problem-solving ability after 3 and 6 months of exercise training, brain function after 6 months of training and physical function after 3 and 6 months of training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Six-month, twice-weekly aerobic training (AT) program
Behavioral: Exercise program (AT)
Six-month, twice-weekly aerobic training (AT) program
Experimental: 2
Six-month, twice-weekly resistance training (RT) program
Behavioral: Exercise training (RT)
Six-month, twice-weekly resistance training (RT) program
Active Comparator: 3
Six-month, twice-weekly stretch & relax (S & R; control) program
Behavioral: Exercise training (S & R; control)
Six-month, twice-weekly stretch & relax (S & R; control) program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Community-dwelling senior women;
  2. Aged 70 years and older;
  3. Subjective memory complaints as determined by interview;
  4. MMSE score > 24/30;
  5. Scored < 26/30 on the MoCA (74);
  6. Visual acuity of at least 20/40, with or without corrective lenses; and
  7. Physician approval for participation in an exercise program.

Exclusion Criteria:

  1. Diagnosed neurodegenerative disease (e.g., AD) and a history of stroke;
  2. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease;
  3. Diagnosed with a psychiatric condition; or
  4. Diagnosed with dementia of any type.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958867

Locations
Canada, British Columbia
Centre for Hip Health Mobility
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Pacific Alzheimer Research Foundation
Investigators
Principal Investigator: Teresa Liu-Ambrose, PhD, PT teresa.ambrose@ubc.ca
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958867     History of Changes
Other Study ID Numbers: H09-00365
Study First Received: August 11, 2009
Last Updated: March 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Resistance exercise training
aerobic exercise training

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014