Body and Brain Exercise for Older Adults With Memory Complaints

September 6, 2016 updated by: Rob Petrella, Lawson Health Research Institute

A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study

The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.

Study Overview

Detailed Description

Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.

Therefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.

The primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Woodstock, Ontario, Canada, N4V 0B1
        • Gymnasium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 55 years or older
  • self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
  • independent on instrumental activities of daily living

Exclusion Criteria:

  • Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score <24)
  • Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
  • Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke <1-year ago; end stage congestive heart failure; end stage renal disease)
  • Severe sensory impairment (i.e., blind)
  • Significant orthopedic conditions (i.e., severe osteoarthritis)
  • Clinical depression (determined via >=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)
  • Have blood pressure >180/100 mmHg or <100/60 mmHg
  • Unable to comprehend questionnaire material
  • Any other factors that could potentially limit ability to fully participate in the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-Modal, Mind Motor Exercise (M4)
Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise.
Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
Other Names:
  • Exercise intervention
Square Step Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids (15 min).
Other Names:
  • Square Stepping Exercise
Active Comparator: Multi-Modal Exercise (M2)
Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises.
Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
Other Names:
  • Exercise intervention
Community-based group exercise designed to improve balance and range of motion of the joints (15 min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Time Frame: 6 months
To assess global cognitive function
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Time Frame: 12 months
To assess global cognitive function
12 months
Gait variability (stride time) under dual-task conditions
Time Frame: 6 & 12 months
Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.
6 & 12 months
Gait variability (stride time) under single-task conditions
Time Frame: 6 & 12 months
Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.
6 & 12 months
Gait velocity (speed) under dual-task conditions
Time Frame: 6 & 12 months
Average walking speed (gait velocity) measured with the GAITRite system
6 & 12 months
Gait velocity (speed) under single-task conditions
Time Frame: 6 & 12 months
Average walking speed (gait velocity) measured with the GAITRite system
6 & 12 months
Step length (average) under dual-task conditions
Time Frame: 6 & 12 months
Mean step length calculated from GAITRite system
6 & 12 months
Step length (average) under single-task conditions
Time Frame: 6 & 12 months
Mean step length calculated from GAITRite system
6 & 12 months
Carotid Artery Compliance
Time Frame: 6 & 12 months
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
6 & 12 months
Carotid Artery Intima-media thickness
Time Frame: 6 & 12 months
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
6 & 12 months
Ambulatory Systolic Blood Pressure
Time Frame: 6 & 12 months
Average systolic blood pressure over a 24 hour time period.
6 & 12 months
Clinic Systolic Blood Pressure
Time Frame: 6 & 12 months
Average systolic blood pressure from in clinic final 2 (out of 3) readings
6 & 12 months
Ambulatory Diastolic Blood Pressure
Time Frame: 6 & 12 months
Average diastolic blood pressure over a 24 hour time period.
6 & 12 months
Clinic Diastolic Blood Pressure
Time Frame: 6 & 12 months
Average diastolic blood pressure from in clinic final 2 (out of 3) readings
6 & 12 months
Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery
Time Frame: 6 & 12 months
6 & 12 months
Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery
Time Frame: 6 & 12 months
6 & 12 months
Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery
Time Frame: 6 & 12 months
6 & 12 months
Total balance score
Time Frame: 6 & 12 months
Total score calculated from the the Fullerton Advanced Balance scale
6 & 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosaccade reaction time in response to flash of light.
Time Frame: 6 months
The reaction time of the eye when instructed to look toward a flash of light.
6 months
Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.
Time Frame: 6 months
Neuroimaging assessment with functional magnetic resonance imaging
6 months
Antisaccade reaction time in response to flash of light.
Time Frame: 6 months
The reaction time of the eye when instructed to look away from a flash of light.
6 months
Change in blood flow to the parietal cortex in response to a randomly selected cognitive task.
Time Frame: 6 months
Neuroimaging assessment with functional magnetic resonance imaging
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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