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Completed

NCT Number: NCT02136368

Body and Brain Exercise for Older Adults With Memory Complaints

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gymnasium

Woodstock, Ontario, N4V 0B1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Multi-modal exercise

Behavioral

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

Mind-Motor Exercise

Behavioral

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

Balance and range of motion exercises

Behavioral

Community-based group exercise designed to improve balance and range of motion of the joints (15 min)

Primary outcomes

  1. Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks

    Time frame: 6 months

    To assess global cognitive function

Secondary outcomes

  1. Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks

    Time frame: 12 months

    To assess global cognitive function

  2. 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.

  3. 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.

  4. Gait velocity (speed) under dual-task conditions

    Time frame: 6 & 12 months

    Average walking speed (gait velocity) measured with the GAITRite system

  5. Gait velocity (speed) under single-task conditions

    Time frame: 6 & 12 months

    Average walking speed (gait velocity) measured with the GAITRite system

  6. Step length (average) under dual-task conditions

    Time frame: 6 & 12 months

    Mean step length calculated from GAITRite system

  7. Step length (average) under single-task conditions

    Time frame: 6 & 12 months

    Mean step length calculated from GAITRite system

  8. 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).

  9. 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).

  10. Ambulatory Systolic Blood Pressure

    Time frame: 6 & 12 months

    Average systolic blood pressure over a 24 hour time period.

  11. Clinic Systolic Blood Pressure

    Time frame: 6 & 12 months

    Average systolic blood pressure from in clinic final 2 (out of 3) readings

  12. Ambulatory Diastolic Blood Pressure

    Time frame: 6 & 12 months

    Average diastolic blood pressure over a 24 hour time period.

  13. Clinic Diastolic Blood Pressure

    Time frame: 6 & 12 months

    Average diastolic blood pressure from in clinic final 2 (out of 3) readings

  14. Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery

    Time frame: 6 & 12 months

  15. Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery

    Time frame: 6 & 12 months

  16. Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery

    Time frame: 6 & 12 months

  17. Total balance score

    Time frame: 6 & 12 months

    Total score calculated from the the Fullerton Advanced Balance scale

Other outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 13, 2014
Registry last updated
Sep 7, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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