Clinical trial NCT04515758: Determining the Feasibility of Implementing a Combined Cognitive and Exercise Training Program for Older Adults in a Community Setting.
Official title: Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis
Osteoporosis
Joint Replacement
Fibromyalgia
High Blood Pressure
Stable Heart Conditions
Chronic Obstructive Pulmonary Disease
Diabetes
Obesity
Keywords: Feasibility
Exercise training
Cognitive Training
Chronic conditions
Older adults
Community setting
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Royal Bank of Canada
name: YMCA
First posted: 2020-08-17
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the exercise only group or the cognitive training and exercise group.
Primary purpose: OTHER

Brief summary: The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

Detailed description: The study will be conducted at the A. R. Kaufman YMCA fitness center where 32 registrants of the "Move for Health Program" (formally known as the Live Smart program) will be asked to participate. The "Move for Health" program is a 12-week, twice-weekly 60 minute program that includes both aerobic and strength training. The cognitive training (delivered by an Android Tablet) focuses on dual-task training and requires participants to employ higher-order cognitive abilities such as attention and executive function. 16 Participants in one group will complete cognitive training integrated into the Move for Health exercise program, whereas 16 participants in the other group (completing program on separate days) will complete the exercise program only. All participants will complete assessments of cognitive function, physical function, well-being, and self-efficacy before and after the programs. This study will be the first to examine the feasibility, acceptability, and effectiveness of a combined cognitive and exercise training program for older adults in a community-setting. If shown to be feasible, it has the potential for broader investigation and, eventually, wide-scale implementation to benefits the health of older Canadians.

Note: Due to low recruitment rates, 11 participants were recruited in the Fall of 2019 and all completed the experimental intervention. 32 participants were recruited and randomized for the Winter of 2020. In response to COVID-19, the YMCA shut down and thus the intervention has halted prematurely after 6 weeks of program. Post-program updated demographic information, activity questionnaires (physical, cognitive, and social), and assessments for overall well-being and self-efficacy will be conducted over phone or video call.

Eligibility criteria: Inclusion Criteria:

* Must be available and willing to participate during the schedule program days and times (which were determined based on the scheduling of other regular YMCA programs)
* Communicate proficiently in English (i.e. would be able to understand and respond to instructions and questions that provided both verbally and in written form in English)
* Must have one or more of the following chronic conditions: including osteoarthritis, osteoporosis, pre/post-joint replacement, fibromyalgia, high blood pressure, stable heart conditions, Chronic Obstructive Pulmonary Disease, diabetes, and/or obesity.
* When wearing their usual corrective lenses, they are able to read standard newsprint
* While wearing their normal hearing aid (if required), they are able to converse with another person in a public area or somewhat crowded room

Exclusion Criteria:

* Currently undergoing treatment for cancer (not included in this specific YMCA program's target participants)
* Has completed this specific YMCA exercise program within the last year
* Has been diagnosed with a concussion and/or has been experiencing concussion-related symptoms in the last 6 months

Primary outcomes:
measure: Recruitment Rate
timeFrame: Pre-program (baseline)
measure: Completion Rate
timeFrame: Through study completion, 12 weeks
measure: Attendance
timeFrame: Throughout entire intervention (12 weeks, 2 sessions/week per group)
measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program
timeFrame: Mid-point (6 weeks) and post-program (12 weeks)
measure: Cost of program
timeFrame: Post-program (12 weeks)
measure: Sex
timeFrame: Pre-program (baseline)
measure: Participant and Instructor perceived program experience and satisfaction
timeFrame: Post-program (at 12 weeks)
measure: Participant and Instructor observer-perceived program experience and satisfaction
timeFrame: Throughout entire intervention (12 weeks, 2 sessions/week per group)
measure: Education
timeFrame: Pre-program (baseline)
measure: Occupation
timeFrame: Pre-program (baseline)
measure: Medical Condition
timeFrame: Pre-program (baseline)
measure: Medications
timeFrame: Pre-program (baseline)
measure: Montreal Cognitive Assessment (global cognitive function)
timeFrame: Pre-program (baseline)
measure: Physical Activity Level
timeFrame: Pre-program (baseline)
measure: Participant cognitive activity
timeFrame: Pre-program (baseline)
measure: Participant social activity
timeFrame: Pre-program (baseline)
measure: Participant and Instructor Age
timeFrame: Pre-program (baseline)
Secondary outcomes:
measure: Change in Stroop Task Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Trail Making Task Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Resting Heart Rate
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Resting Systolic and Diastolic Blood Pressure
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Grip Strength
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Body Mass Index (BMI)
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Hip-to-Waist Circumference Ratio
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Timed Up-and-Go Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Four Square Step Test Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Sit-to-Stand Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in 6-minute walk test Performance
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Overall Well-being
timeFrame: Pre-program (baseline) and post-program (12 weeks)
measure: Change in Exercise-related Self-Efficacy
timeFrame: Pre-program (baseline) and post-program (12 weeks)
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: A. R. Kaufman YMCA
state: Ontario
Study officials:
References: