Determining the Feasibility of Implementing a Combined Cognitive and Exercise Training Program for Older Adults in a Community Setting.
- Conditions
- Osteo ArthritisStable Heart ConditionsChronic Obstructive Pulmonary DiseaseDiabetesOsteoporosisJoint ReplacementHigh Blood PressureFibromyalgiaObesity
- Interventions
- Other: Exercise Training OnlyOther: Exercise and Cognitive Training
- Registration Number
- NCT04515758
- Lead Sponsor
- University of Waterloo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Training Only Exercise Training Only Each participant (in a group setting) completes 1 hour of exercise two days/week (separate days than the experimental group). Exercise and Cognitive Training Exercise and Cognitive Training Each participant (in a group setting) completes 30 minutes of cognitive training and 1 hour of exercise two days/week.
- Primary Outcome Measures
Name Time Method Completion Rate Through study completion, 12 weeks Percentage of people who completed the full program and all assessments
Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program Mid-point (6 weeks) and post-program (12 weeks) Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.
Medications Pre-program (baseline) Self-reported previous and current medications using basic demographics questionnaire
Sex Pre-program (baseline) Self-reported biological sex (at birth) using basic demographics questionnaire
Participant and Instructor perceived program experience and satisfaction Post-program (at 12 weeks) One-on-one interview with researcher, answering broad questions about their experience in the program and study
Education Pre-program (baseline) Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire
Occupation Pre-program (baseline) Self-reported previous and current occupations using basic demographics questionnaire
Participant cognitive activity Pre-program (baseline) Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.
Participant social activity Pre-program (baseline) Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.
Recruitment Rate Pre-program (baseline) Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)
Attendance Throughout entire intervention (12 weeks, 2 sessions/week per group) Percentage of people who attended program sessions (exercise and cognitive training components)
Participant and Instructor observer-perceived program experience and satisfaction Throughout entire intervention (12 weeks, 2 sessions/week per group) Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.
Cost of program Post-program (12 weeks) Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff
Medical Condition Pre-program (baseline) Self-reported previous and current medical conditions using basic demographics questionnaire
Montreal Cognitive Assessment (global cognitive function) Pre-program (baseline) Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).
Physical Activity Level Pre-program (baseline) Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).
Participant and Instructor Age Pre-program (baseline) Self-reported years of age using basic demographics questionnaire
- Secondary Outcome Measures
Name Time Method Change in Grip Strength Pre-program (baseline) and post-program (12 weeks) Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)
Change in Hip-to-Waist Circumference Ratio Pre-program (baseline) and post-program (12 weeks) Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation
Change in Timed Up-and-Go Performance Pre-program (baseline) and post-program (12 weeks) Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.
Change in Resting Heart Rate Pre-program (baseline) and post-program (12 weeks) Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff
Change in Resting Systolic and Diastolic Blood Pressure Pre-program (baseline) and post-program (12 weeks) Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff
Change in Body Mass Index (BMI) Pre-program (baseline) and post-program (12 weeks) Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m\^2)
Change in 6-minute walk test Performance Pre-program (baseline) and post-program (12 weeks) Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.
Change in Stroop Task Performance Pre-program (baseline) and post-program (12 weeks) STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.
Change in Trail Making Task Performance Pre-program (baseline) and post-program (12 weeks) Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.
Change in Four Square Step Test Performance Pre-program (baseline) and post-program (12 weeks) Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.
Change in Sit-to-Stand Performance Pre-program (baseline) and post-program (12 weeks) Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.
Change in Overall Well-being Pre-program (baseline) and post-program (12 weeks) Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).
Change in Exercise-related Self-Efficacy Pre-program (baseline) and post-program (12 weeks) Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score
Trial Locations
- Locations (1)
A. R. Kaufman YMCA
šØš¦Kitchener, Ontario, Canada