Body and Brain Exercise for Older Adults With Memory Complaints

Cognitive Ability, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136368
• Other study ID #: M4W18858
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: September 6, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognitive Ability, General

Intervention

Behavioral:
• Multi-modal 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)
• Mind-Motor Exercise
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).
• Balance and range of motion exercises
Community-based group exercise designed to improve balance and range of motion of the joints (15 min)

Locations

Country	Name	City	State
Canada	Gymnasium	Woodstock	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prosaccade reaction time in response to flash of light.	The reaction time of the eye when instructed to look toward a flash of light.	6 months	No
Other	Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.	Neuroimaging assessment with functional magnetic resonance imaging	6 months	No
Other	Antisaccade reaction time in response to flash of light.	The reaction time of the eye when instructed to look away from a flash of light.	6 months	No
Other	Change in blood flow to the parietal cortex in response to a randomly selected cognitive task.	Neuroimaging assessment with functional magnetic resonance imaging	6 months	No
Primary	Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks	To assess global cognitive function	6 months	No
Secondary	Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks	To assess global cognitive function	12 months	No
Secondary	Gait variability (stride time) under dual-task conditions	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	No
Secondary	Gait variability (stride time) under single-task conditions	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	No
Secondary	Gait velocity (speed) under dual-task conditions	Average walking speed (gait velocity) measured with the GAITRite system	6 & 12 months	No
Secondary	Gait velocity (speed) under single-task conditions	Average walking speed (gait velocity) measured with the GAITRite system	6 & 12 months	No
Secondary	Step length (average) under dual-task conditions	Mean step length calculated from GAITRite system	6 & 12 months	No
Secondary	Step length (average) under single-task conditions	Mean step length calculated from GAITRite system	6 & 12 months	No
Secondary	Carotid Artery Compliance	Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).	6 & 12 months	No
Secondary	Carotid Artery Intima-media thickness	Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).	6 & 12 months	No
Secondary	Ambulatory Systolic Blood Pressure	Average systolic blood pressure over a 24 hour time period.	6 & 12 months	No
Secondary	Clinic Systolic Blood Pressure	Average systolic blood pressure from in clinic final 2 (out of 3) readings	6 & 12 months	No
Secondary	Ambulatory Diastolic Blood Pressure	Average diastolic blood pressure over a 24 hour time period.	6 & 12 months	No
Secondary	Clinic Diastolic Blood Pressure	Average diastolic blood pressure from in clinic final 2 (out of 3) readings	6 & 12 months	No
Secondary	Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery		6 & 12 months	No
Secondary	Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery		6 & 12 months	No
Secondary	Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery		6 & 12 months	No
Secondary	Total balance score	Total score calculated from the the Fullerton Advanced Balance scale	6 & 12 months	No