Osteo ArthritisNCT04515758
Determining the Feasibility of Implementing a Combined Cognitive and Exercise Training Program for Older Adults in a Community Setting.
A study testing Exercise and Cognitive Training and Exercise Training Only in people with Osteo Arthritis and Osteoporosis, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteo Arthritis, Osteoporosis, Joint Replacement
- What is being tested?
- Exercise and Cognitive Training and Exercise Training Only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 24 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness
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.
Read the 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
- Being tested
- Exercise and Cognitive Training, Exercise Training Only
- Keywords
- Feasibility, Exercise training, Cognitive Training, Chronic conditions, Older adults, Community setting
- Medical subject headings
- Osteoporosis, Fibromyalgia, Hypertension, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Cognitive TrainingOther
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 OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Exercise Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)
Measured: Pre-program (baseline)
Completion Rate
Percentage of people who completed the full program and all assessments
Measured: Through study completion, 12 weeks
Attendance
Percentage of people who attended program sessions (exercise and cognitive training components)
Measured: 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.
Measured: 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
Measured: Post-program (12 weeks)
Sex
Self-reported biological sex (at birth) using basic demographics questionnaire
Measured: 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
Measured: 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.
Measured: 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
Measured: Pre-program (baseline)
Occupation
Self-reported previous and current occupations using basic demographics questionnaire
Measured: Pre-program (baseline)
Medical Condition
Self-reported previous and current medical conditions using basic demographics questionnaire
Measured: Pre-program (baseline)
Medications
Self-reported previous and current medications using basic demographics questionnaire
Measured: 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).
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).
Measured: 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.
Measured: 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.
Measured: Pre-program (baseline)
Participant and Instructor Age
Self-reported years of age using basic demographics questionnaire
Measured: Pre-program (baseline)
Secondary outcomes (13)
Change in Stroop Task Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Trail Making Task Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Resting Heart Rate
Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Resting Systolic and Diastolic Blood Pressure
Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Grip Strength
Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Body Mass Index (BMI)
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)
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Hip-to-Waist Circumference Ratio
Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Timed Up-and-Go Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Four Square Step Test Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Sit-to-Stand Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in 6-minute walk test Performance
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.
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Overall Well-being
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).
Measured: Pre-program (baseline) and post-program (12 weeks)
Change in Exercise-related Self-Efficacy
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
Measured: Pre-program (baseline) and post-program (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Apr 2019
- Primary completion12 Mar 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the exercise only group or the cognitive training and exercise group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bank of Canada, YMCA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515758
- Sponsor's protocol ID
- 40928
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness
- ClinicalTrials.gov ID
- NCT04515758
- Acronym / sponsor ID
- 40928
- Conditions
- Osteo Arthritis, Osteoporosis, Joint Replacement, Fibromyalgia, High Blood Pressure, Stable Heart Conditions
- Keywords
- Feasibility, Exercise training, Cognitive Training, Chronic conditions, Older adults, Community setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Royal Bank of Canada, YMCA
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the exercise only group or the cognitive training and exercise group.
| Arm | Type | Receives |
|---|---|---|
| Exercise and Cognitive Training | Experimental | Other: Exercise and Cognitive TrainingEach participant (in a group setting) completes 30 minutes of cognitive training and 1 hour of exercise two days/week. |
| Exercise Training Only | Active comparator | Other: Exercise Training OnlyEach participant (in a group setting) completes 1 hour of exercise two days/week (separate days than the experimental group). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and Cognitive TrainingExercise: 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. | Other | Exercise and Cognitive Training |
| Exercise Training OnlyExercise: 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. | Other | Exercise Training Only |
Primary outcome
Recruitment Rate
Time frame: 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)
Completion Rate
Time frame: Through study completion, 12 weeks
Percentage of people who completed the full program and all assessments
Attendance
Time frame: Throughout entire intervention (12 weeks, 2 sessions/week per group)
Percentage of people who attended program sessions (exercise and cognitive training components)
Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program
Time frame: 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.
Cost of program
Time frame: 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
Sex
Time frame: Pre-program (baseline)
Self-reported biological sex (at birth) using basic demographics questionnaire
Participant and Instructor perceived program experience and satisfaction
Time frame: Post-program (at 12 weeks)
One-on-one interview with researcher, answering broad questions about their experience in the program and study
Participant and Instructor observer-perceived program experience and satisfaction
Time frame: 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.
Education
Time frame: Pre-program (baseline)
Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire
Occupation
Time frame: Pre-program (baseline)
Self-reported previous and current occupations using basic demographics questionnaire
Medical Condition
Time frame: Pre-program (baseline)
Self-reported previous and current medical conditions using basic demographics questionnaire
Medications
Time frame: Pre-program (baseline)
Self-reported previous and current medications using basic demographics questionnaire
Montreal Cognitive Assessment (global cognitive function)
Time frame: 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
Time frame: 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 cognitive activity
Time frame: 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
Time frame: 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.
Participant and Instructor Age
Time frame: Pre-program (baseline)
Self-reported years of age using basic demographics questionnaire
13 secondary outcomes
Change in Stroop Task Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Trail Making Task Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Resting Heart Rate
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Resting Systolic and Diastolic Blood Pressure
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Grip Strength
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Body Mass Index (BMI)
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Hip-to-Waist Circumference Ratio
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Timed Up-and-Go Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Four Square Step Test Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Sit-to-Stand Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in 6-minute walk test Performance
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Overall Well-being
Time frame: Pre-program (baseline) and post-program (12 weeks)
Change in Exercise-related Self-Efficacy
Time frame: Pre-program (baseline) and post-program (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive Training and Exercise Training Only in people with Osteo Arthritis and Osteoporosis, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Pre-program (baseline)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.