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

NCT04515758 | Completed

• 1 other identifier: 40928
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (17)

• Recruitment Rate

  Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

  Pre-program (baseline)

• Completion Rate

  Percentage of people who completed the full program and all assessments

  Through study completion, 12 weeks

• Attendance

  Percentage of people who attended program sessions (exercise and cognitive training components)

  Throughout entire intervention (12 weeks, 2 sessions/week per group)

• Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

  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.

  Mid-point (6 weeks) and post-program (12 weeks)

• Cost of program

  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

  Post-program (12 weeks)

• Sex

  Self-reported biological sex (at birth) using basic demographics questionnaire

  Pre-program (baseline)

• Participant and Instructor perceived program experience and satisfaction

  One-on-one interview with researcher, answering broad questions about their experience in the program and study

  Post-program (at 12 weeks)

• Participant and Instructor observer-perceived program experience and satisfaction

  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.

  Throughout entire intervention (12 weeks, 2 sessions/week per group)

• Education

  Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

  Pre-program (baseline)

• Occupation

  Self-reported previous and current occupations using basic demographics questionnaire

  Pre-program (baseline)

• Medical Condition

  Self-reported previous and current medical conditions using basic demographics questionnaire

  Pre-program (baseline)

• Medications

  Self-reported previous and current medications using basic demographics questionnaire

  Pre-program (baseline)

• Montreal Cognitive Assessment (global cognitive function)

  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).

  Pre-program (baseline)

• Physical Activity Level

  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).

  Pre-program (baseline)

• Participant cognitive activity

  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.

  Pre-program (baseline)

• Participant social activity

  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.

  Pre-program (baseline)

• Participant and Instructor Age

  Self-reported years of age using basic demographics questionnaire

  Pre-program (baseline)

Secondary Outcomes (13)

• 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 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 Grip Strength

  Pre-program (baseline) and post-program (12 weeks)

Study Arms (2)

Exercise and Cognitive Training

EXPERIMENTAL

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

Other: Exercise and Cognitive Training

Exercise Training Only

ACTIVE COMPARATOR

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

Other: Exercise Training Only

Interventions

Exercise and Cognitive Training 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 and Cognitive Training

Exercise Training Only 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.

Exercise Training Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Waterloo: lead
• Royal Bank of Canada: collaborator
• YMCA: collaborator

Study Sites (1)

A. R. Kaufman YMCA

Kitchener, Ontario, N2G 3C5, Canada

Location

MeSH Terms

Conditions

Osteoporosis; Fibromyalgia; Hypertension; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Obesity; Chronic Disease

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the exercise only group or the cognitive training and exercise group.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: August 17, 2020
• Study Start: April 1, 2019
• Primary Completion: March 12, 2020
• Study Completion: April 24, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)