Determining the Feasibility of Implementing a Combined Cognitive and Exercise Training Program for Older Adults in a Community Setting.

NCT ID: NCT04515758

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-04-24

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.

Conditions

Osteo Arthritis; Osteoporosis; Joint Replacement; Fibromyalgia; High Blood Pressure; Stable Heart Conditions; Chronic Obstructive Pulmonary Disease; Diabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Exercise and Cognitive Training

Each participant (in a group setting) completes 30 minutes of cognitive training and 1 hour of exercise two days/week.

Group Type: EXPERIMENTAL

Exercise and Cognitive Training

Intervention Type: OTHER

Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class. Cognitive training: focuses on dual-task training (provided by an Android tablet). Each cognitive task requires the participant to choose and execute the response appropriate for the stimuli presented. Participants must prioritize their response and perform tasks as fast as possible while maintaining accuracy. The difficulty of the training is individualized and progressive based on their ongoing performance.

Exercise Training Only

Each participant (in a group setting) completes 1 hour of exercise two days/week (separate days than the experimental group).

Group Type: ACTIVE_COMPARATOR

Exercise Training Only

Intervention Type: OTHER

Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class.

Interventions

Exercise and Cognitive Training

Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class. Cognitive training: focuses on dual-task training (provided by an Android tablet). Each cognitive task requires the participant to choose and execute the response appropriate for the stimuli presented. Participants must prioritize their response and perform tasks as fast as possible while maintaining accuracy. The difficulty of the training is individualized and progressive based on their ongoing performance.

Intervention Type: OTHER

Exercise Training Only

Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Bank of Canada

UNKNOWN

Sponsor Role: collaborator

YMCA

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

A. R. Kaufman YMCA

Kitchener, Ontario, Canada

Countries

Canada

Other Identifiers

40928

Identifier Type: -

Identifier Source: org_study_id