Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Completion Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are told that there are two intervention groups ("regular exercise group" and an "augmented exercise group"). They are not told how the two group interventions differ (i.e. they are unaware of which group they were assigned to, as they do not know what intervention is being delivered to the other group). Assessors of the outcomes are not aware of which group the participant's have been assigned to.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Completion Rate
时间窗: 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
时间窗: 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
时间窗: Pre-program (baseline)
Self-reported previous and current medications using basic demographics questionnaire
Sex
时间窗: Pre-program (baseline)
Self-reported biological sex (at birth) using basic demographics questionnaire
Participant and Instructor perceived program experience and satisfaction
时间窗: Post-program (at 12 weeks)
One-on-one interview with researcher, answering broad questions about their experience in the program and study
Education
时间窗: Pre-program (baseline)
Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire
Occupation
时间窗: Pre-program (baseline)
Self-reported previous and current occupations using basic demographics questionnaire
Participant cognitive activity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Pre-program (baseline)
Self-reported previous and current medical conditions using basic demographics questionnaire
Montreal Cognitive Assessment (global cognitive function)
时间窗: 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
时间窗: 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
时间窗: Pre-program (baseline)
Self-reported years of age using basic demographics questionnaire
次要结局
- Change in Grip Strength(Pre-program (baseline) and post-program (12 weeks))
- Change in Hip-to-Waist Circumference Ratio(Pre-program (baseline) and post-program (12 weeks))
- Change in Timed Up-and-Go Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Resting Heart Rate(Pre-program (baseline) and post-program (12 weeks))
- Change in Resting Systolic and Diastolic Blood Pressure(Pre-program (baseline) and post-program (12 weeks))
- Change in Body Mass Index (BMI)(Pre-program (baseline) and post-program (12 weeks))
- Change in 6-minute walk test Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Stroop Task Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Trail Making Task Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Four Square Step Test Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Sit-to-Stand Performance(Pre-program (baseline) and post-program (12 weeks))
- Change in Overall Well-being(Pre-program (baseline) and post-program (12 weeks))
- Change in Exercise-related Self-Efficacy(Pre-program (baseline) and post-program (12 weeks))