Body and Brain Exercise for Older Adults With Memory Complaints

Not Applicable

Completed

• Conditions: Cognitive Ability, General
• Interventions: Behavioral: Multi-modal exercise; Behavioral: Mind-Motor Exercise; Behavioral: Balance and range of motion exercises

• Registration Number: NCT02136368
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Modal, Mind Motor Exercise (M4)	Mind-Motor Exercise	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.
Multi-Modal, Mind Motor Exercise (M4)	Multi-modal exercise	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.
Multi-Modal Exercise (M2)	Multi-modal exercise	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.
Multi-Modal Exercise (M2)	Balance and range of motion exercises	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.

Primary Outcome Measures

Name	Time	Method
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks	6 months	To assess global cognitive function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gymnasium; 🇨🇦 Woodstock, Ontario, Canada