Clinical trial NCT02136368: Body and Brain Exercise for Older Adults With Memory Complaints
Official title: A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Keywords: older adults
multiple-modality exercise
mind-motor exercise
self-reported cognitive complaints
global cognitive functioning
mobility
vascular function
sensorimotor function
brain imaging
community-based research
subjective cognitive complaints
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-05-13
Enrollment: 127
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
timeFrame: 6 months
Secondary outcomes:
measure: Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
timeFrame: 12 months
measure: Gait variability (stride time) under dual-task conditions
timeFrame: 6 & 12 months
measure: Gait variability (stride time) under single-task conditions
timeFrame: 6 & 12 months
measure: Gait velocity (speed) under dual-task conditions
timeFrame: 6 & 12 months
measure: Gait velocity (speed) under single-task conditions
timeFrame: 6 & 12 months
measure: Step length (average) under dual-task conditions
timeFrame: 6 & 12 months
measure: Step length (average) under single-task conditions
timeFrame: 6 & 12 months
measure: Carotid Artery Compliance
timeFrame: 6 & 12 months
measure: Carotid Artery Intima-media thickness
timeFrame: 6 & 12 months
measure: Ambulatory Systolic Blood Pressure
timeFrame: 6 & 12 months
measure: Clinic Systolic Blood Pressure
timeFrame: 6 & 12 months
measure: Ambulatory Diastolic Blood Pressure
timeFrame: 6 & 12 months
measure: Clinic Diastolic Blood Pressure
timeFrame: 6 & 12 months
measure: Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery
timeFrame: 6 & 12 months
measure: Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery
timeFrame: 6 & 12 months
measure: Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery
timeFrame: 6 & 12 months
measure: Total balance score
timeFrame: 6 & 12 months
Other outcomes:
measure: Prosaccade reaction time in response to flash of light.
timeFrame: 6 months
measure: Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.
timeFrame: 6 months
measure: Antisaccade reaction time in response to flash of light.
timeFrame: 6 months
measure: Change in blood flow to the parietal cortex in response to a randomly selected cognitive task.
timeFrame: 6 months
Locations:
city: Woodstock
country: Canada
facility: Gymnasium
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Robert J Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boa Sorte Silva NC, Nagamatsu LS, Gill DP, Owen AM, Petrella RJ. Memory Function and Brain Functional Connectivity Adaptations Following Multiple-Modality Exercise and Mind-Motor Training in Older Adults at Risk of Dementia: An Exploratory Sub-Study. Front Aging Neurosci. 2020 Feb 25;12:22. doi: 10.3389/fnagi.2020.00022. eCollection 2020.
citation: Gregory MA, Gill DP, Shellington EM, Liu-Ambrose T, Shigematsu R, Zou G, Shoemaker K, Owen AM, Hachinski V, Stuckey M, Petrella RJ. Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol. BMC Geriatr. 2016 Jan 16;16:17. doi: 10.1186/s12877-016-0190-9.