A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Multi-modal exercise (Behavioral)
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.
Intervention: Mind-Motor Exercise (Behavioral)
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.
Intervention: Multi-modal exercise (Behavioral)
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.
Intervention: Balance and range of motion exercises (Behavioral)
Outcomes
Primary Outcomes
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Time Frame: 6 months
To assess global cognitive function
Secondary Outcomes
- Gait variability (stride time) under dual-task conditions(6 & 12 months)
- Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks(12 months)
- Gait velocity (speed) under dual-task conditions(6 & 12 months)
- Gait velocity (speed) under single-task conditions(6 & 12 months)
- Step length (average) under dual-task conditions(6 & 12 months)
- 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)
- Step length (average) under single-task conditions(6 & 12 months)
- Carotid Artery Compliance(6 & 12 months)
- Carotid Artery Intima-media thickness(6 & 12 months)
- Ambulatory Systolic Blood Pressure(6 & 12 months)
- Clinic Diastolic Blood Pressure(6 & 12 months)
- Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery(6 & 12 months)
- Clinic Systolic Blood Pressure(6 & 12 months)
- Ambulatory Diastolic Blood Pressure(6 & 12 months)
- Total balance score(6 & 12 months)
- Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery(6 & 12 months)
Investigators
Rob Petrella
Principal Investigator
Lawson Health Research Institute