NCT00958867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

Same day

First QC Date

August 11, 2009

Last Update Submit

October 1, 2017

Conditions

Keywords

Resistance exercise trainingaerobic exercise training

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance after 3 and 6 months of training

    6 months

Secondary Outcomes (1)

  • 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

    6 months

Study Arms (3)

1

EXPERIMENTAL

Six-month, twice-weekly aerobic training (AT) program

Behavioral: Exercise program (AT)

2

EXPERIMENTAL

Six-month, twice-weekly resistance training (RT) program

Behavioral: Exercise training (RT)

3

ACTIVE COMPARATOR

Six-month, twice-weekly stretch \& relax (S \& R; control) program

Behavioral: Exercise training (S & R; control)

Interventions

Six-month, twice-weekly aerobic training (AT) program

1

Six-month, twice-weekly resistance training (RT) program

2

Six-month, twice-weekly stretch \& relax (S \& R; control) program

3

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diagnosed neurodegenerative disease (e.g., AD) and a history of stroke;
  • Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease;
  • Diagnosed with a psychiatric condition; or
  • Diagnosed with dementia of any type.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Hip Health Mobility

Vancouver, British Columbia, Canada

Location

Related Publications (2)

  • ten Brinke LF, Bolandzadeh N, Nagamatsu LS, Hsu CL, Davis JC, Miran-Khan K, Liu-Ambrose T. Aerobic exercise increases hippocampal volume in older women with probable mild cognitive impairment: a 6-month randomised controlled trial. Br J Sports Med. 2015 Feb;49(4):248-54. doi: 10.1136/bjsports-2013-093184. Epub 2014 Apr 7.

  • Davis JC, Bryan S, Marra CA, Sharma D, Chan A, Beattie BL, Graf P, Liu-Ambrose T. An economic evaluation of resistance training and aerobic training versus balance and toning exercises in older adults with mild cognitive impairment. PLoS One. 2013 May 14;8(5):e63031. doi: 10.1371/journal.pone.0063031. Print 2013.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Teresa Liu-Ambrose, PhD, PT

    teresa.ambrose@ubc.ca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

March 1, 2010

Last Updated

October 4, 2017

Record last verified: 2017-10

Locations