- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929393
Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study (Y-U)
July 12, 2023 updated by: University of Minnesota
Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study
Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs.
Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities.
This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Burnsville, Minnesota, United States, 55337
- YMCA Burnsville
-
Edina, Minnesota, United States, 55435
- YMCA Southdale
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
Minneapolis, Minnesota, United States, 55405
- YMCA Cora McCorvey
-
Saint Paul, Minnesota, United States, 55104
- YMCA Midway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
≥ 50 years of age
- Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between baselines
- Self-report of <140 minutes of MVPA per week in 3 months prior to baseline AND accelerometer recorded <100 minutes of MVPA between baselines
- Mini-Mental State score ≥ 24 if indicated
- Independent self-ambulation
- Provides consent and is willing to participate in data collection activities
Exclusion Criteria:
- Pregnancy
- Unwilling or unable to participate in study activities
- Current or upcoming participation in educational programs similar to those under study
- Medical restrictions to increasing Moderate Vigorous Physical Activity (MVPA)
- Terminal illness
- Contraindications to mindfulness practice
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindful Movement
8, 90-minute, in-person, group sessions over 8 weeks
|
The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social suppo
|
Active Comparator: Keys to Health & Wellbeing
8, 90-minute, in-person, group sessions over 8 weeks
|
This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Baseline
|
Minutes/week spent in ≥10-min bouts of MVPA
|
Baseline
|
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 9 weeks - baseline
|
Minutes/week spent in ≥10-min bouts of MVPA
|
Change score: 9 weeks - baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 26 weeks - baseline
|
Minutes/week spent in ≥10-min bouts of MVPA
|
Change score: 26 weeks - baseline
|
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 52 weeks - baseline
|
Minutes/week spent in ≥10-min bouts of MVPA
|
Change score: 52 weeks - baseline
|
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Baseline
|
Minutes/week spent in MVPA
|
Baseline
|
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 9 weeks - baseline
|
Minutes/week spent in MVPA
|
Change score: 9 weeks - baseline
|
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 26 weeks - baseline
|
Minutes/week spent in MVPA
|
Change score: 26 weeks - baseline
|
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 52 weeks - baseline
|
Minutes/week spent in MVPA
|
Change score: 52 weeks - baseline
|
Sedentary Activity
Time Frame: Baseline
|
Time spent in sedentary activity
|
Baseline
|
Sedentary Activity
Time Frame: Change score: 9 weeks - baseline
|
Time spent in sedentary activity
|
Change score: 9 weeks - baseline
|
Sedentary Activity
Time Frame: Change score: 26 weeks - baseline
|
Time spent in sedentary activity
|
Change score: 26 weeks - baseline
|
Sedentary Activity
Time Frame: Change score: 52 weeks - baseline
|
Time spent in sedentary activity
|
Change score: 52 weeks - baseline
|
Average Daily Step Count
Time Frame: Baseline
|
Average steps/day over one week
|
Baseline
|
Average Daily Step Count
Time Frame: Change score: 9 weeks - baseline
|
Average steps/day over one week
|
Change score: 9 weeks - baseline
|
Average Daily Step Count
Time Frame: Change score: 26 weeks - baseline
|
Average steps/day over one week
|
Change score: 26 weeks - baseline
|
Average Daily Step Count
Time Frame: Change score: 52 weeks - baseline
|
Average steps/day over one week
|
Change score: 52 weeks - baseline
|
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: Baseline
|
The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem).
The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.
|
Baseline
|
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: Change score: 9 weeks - baseline
|
The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem).
The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.
|
Change score: 9 weeks - baseline
|
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: Change score: 26 weeks - baseline
|
The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem).
The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.
|
Change score: 26 weeks - baseline
|
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: Change score: 52 weeks - baseline
|
The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem).
The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.
|
Change score: 52 weeks - baseline
|
Quality of Life - EuroQol VAS
Time Frame: Baseline
|
The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Results are on a 0 to 100 scale with higher scores indicating better self-rated health.
|
Baseline
|
Quality of Life - EuroQol VAS
Time Frame: Change score: 9 weeks - baseline
|
The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Results are on a 0 to 100 scale with higher scores indicating better self-rated health.
|
Change score: 9 weeks - baseline
|
Quality of Life - EuroQol VAS
Time Frame: Change score: 26 weeks - baseline
|
The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Results are on a 0 to 100 scale with higher scores indicating better self-rated health.
|
Change score: 26 weeks - baseline
|
Quality of Life - EuroQol VAS
Time Frame: Change score: 52 weeks - baseline
|
The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Results are on a 0 to 100 scale with higher scores indicating better self-rated health.
|
Change score: 52 weeks - baseline
|
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: Baseline
|
Individuals are asked to rate their confidence in their ability to exercise.
Confidence ratings range from 0 (not confident) to 10 (very confident).
The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.
|
Baseline
|
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: Change score: 9 weeks - baseline
|
Individuals are asked to rate their confidence in their ability to exercise.
Confidence ratings range from 0 (not confident) to 10 (very confident).
The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.
|
Change score: 9 weeks - baseline
|
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: Change score: 26 weeks - baseline
|
Individuals are asked to rate their confidence in their ability to exercise.
Confidence ratings range from 0 (not confident) to 10 (very confident).
The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.
|
Change score: 26 weeks - baseline
|
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: Change score: 52 weeks - baseline
|
Individuals are asked to rate their confidence in their ability to exercise.
Confidence ratings range from 0 (not confident) to 10 (very confident).
The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.
|
Change score: 52 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: Baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: Change score: 9 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 9 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: Change score: 26 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 26 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: Change score: 52 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 52 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: Baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: Change score: 9 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 9 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: Change score: 26 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 26 weeks - baseline
|
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: Change score: 52 weeks - baseline
|
This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise.
The OEE-2 includes positive and negative outcome expectations sub-scales.
Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.
|
Change score: 52 weeks - baseline
|
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: Baseline
|
The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never).
Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.
|
Baseline
|
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: Change score: 9 weeks - baseline
|
The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never).
Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.
|
Change score: 9 weeks - baseline
|
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: Change score: 26 weeks - baseline
|
The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never).
Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.
|
Change score: 26 weeks - baseline
|
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: Change score: 52 weeks - baseline
|
The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never).
Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.
|
Change score: 52 weeks - baseline
|
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: Baseline
|
The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always).
Items are summed scores ranging from 14 to 56.
Higher scores indicate more mindfulness.
|
Baseline
|
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: Change score: 9 weeks - baseline
|
The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always).
Items are summed scores ranging from 14 to 56.
Higher scores indicate more mindfulness.
|
Change score: 9 weeks - baseline
|
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: Change score: 26 weeks - baseline
|
The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always).
Items are summed scores ranging from 14 to 56.
Higher scores indicate more mindfulness.
|
Change score: 26 weeks - baseline
|
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: Change score: 52 weeks - baseline
|
The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always).
Items are summed scores ranging from 14 to 56.
Higher scores indicate more mindfulness.
|
Change score: 52 weeks - baseline
|
Wellbeing-8-item Flourishing Scale
Time Frame: Baseline
|
This 8 item scale assesses perceived success in relationships, self-esteem, and purpose.
Responses are 7=Strongly Agree to 1=Strongly Disagree.
The total score ranges from 8 to 56.
Higher scores indicate better perceived wellbeing.
|
Baseline
|
Wellbeing-8-item Flourishing Scale
Time Frame: Change score: 9 weeks - baseline
|
This 8 item scale assesses perceived success in relationships, self-esteem, and purpose.
Responses are 7=Strongly Agree to 1=Strongly Disagree.
The total score ranges from 8 to 56.
Higher scores indicate better perceived wellbeing.
|
Change score: 9 weeks - baseline
|
Wellbeing-8-item Flourishing Scale
Time Frame: Change score: 26 weeks - baseline
|
This 8 item scale assesses perceived success in relationships, self-esteem, and purpose.
Responses are 7=Strongly Agree to 1=Strongly Disagree.
The total score ranges from 8 to 56.
Higher scores indicate better perceived wellbeing.
|
Change score: 26 weeks - baseline
|
Wellbeing-8-item Flourishing Scale
Time Frame: Change score: 52 weeks - baseline
|
This 8 item scale assesses perceived success in relationships, self-esteem, and purpose.
Responses are 7=Strongly Agree to 1=Strongly Disagree.
The total score ranges from 8 to 56.
Higher scores indicate better perceived wellbeing.
|
Change score: 52 weeks - baseline
|
Social Connectedness
Time Frame: Baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social connectedness.
|
Baseline
|
Social Connectedness
Time Frame: Change score: 9 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social connectedness.
|
Change score: 9 weeks - baseline
|
Social Connectedness
Time Frame: Change score: 26 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social connectedness.
|
Change score: 26 weeks - baseline
|
Social Connectedness
Time Frame: Change score: 52 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social connectedness.
|
Change score: 52 weeks - baseline
|
Social Assuredness
Time Frame: Baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social assuredness or confidence.
|
Baseline
|
Social Assuredness
Time Frame: Change score: 9 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social assuredness or confidence.
|
Change score: 9 weeks - baseline
|
Social Assuredness
Time Frame: Change score: 26 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social assuredness or confidence.
|
Change score: 26 weeks - baseline
|
Social Assuredness
Time Frame: Change score: 52 weeks - baseline
|
Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree.
Items are summed with the total scale ranging from 8 to 48.
Higher scores indicates more social assuredness or confidence.
|
Change score: 52 weeks - baseline
|
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline
|
Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.
|
Baseline
|
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: Change score: 9 weeks - baseline
|
Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.
|
Change score: 9 weeks - baseline
|
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: Change score: 26 weeks - baseline
|
Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.
|
Change score: 26 weeks - baseline
|
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: Change score: 52 weeks - baseline
|
Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.
|
Change score: 52 weeks - baseline
|
Satisfaction With Intervention
Time Frame: 9 weeks
|
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
|
9 weeks
|
Satisfaction With Intervention
Time Frame: 26 weeks
|
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
|
26 weeks
|
Satisfaction With Intervention
Time Frame: 52 weeks
|
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
|
52 weeks
|
Frequency of Home Practice
Time Frame: 9 weeks
|
Participants will report the number of days per week they were able to practice skills taught in the program
|
9 weeks
|
Frequency of Home Practice
Time Frame: 26 weeks
|
Participants will report the number of days per week they were able to practice skills taught in the program
|
26 weeks
|
Frequency of Home Practice
Time Frame: 52 weeks
|
Participants will report the number of days per week they were able to practice skills taught in the program
|
52 weeks
|
Pain-11 Box Numerical Rating Scale
Time Frame: Baseline
|
An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week.
The highest score for the assessed body regions was used for analysis.
|
Baseline
|
Pain-11 Box Numerical Rating Scale
Time Frame: Change score: 9 weeks - baseline
|
An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week.
The highest score for the assessed body regions was used for analysis.
|
Change score: 9 weeks - baseline
|
Pain-11 Box Numerical Rating Scale
Time Frame: Change score: 26 weeks - baseline
|
An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week.
The highest score for the assessed body regions was used for analysis.
|
Change score: 26 weeks - baseline
|
Pain-11 Box Numerical Rating Scale
Time Frame: Change score: 52 weeks - baseline
|
An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week.
The highest score for the assessed body regions was used for analysis.
|
Change score: 52 weeks - baseline
|
Telehealth Usability Questionnaire
Time Frame: 9 weeks
|
Participant views of the remote intervention platform (Zoom video-conferencing system) were assessed using the Telehealth Usability Questionnaire (TUQ).
The TUQ assesses usability with 21 questions rated on a 1 to 7 scale.
The overall score is an average of all items with higher scores indicating higher usability of the telehealth system.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt uncomfortable with the facilitators.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A lower score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt uncomfortable with certain participants in the group.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A lower score indicates a higher bond with the group.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI task sub-scale asking participants how often they felt confused by what they were being asked to do in the sessions.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A lower score indicates a higher task alliance with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt the facilitators liked them.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt the facilitators were genuinely concerned for their welfare.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt the facilitators respected them.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt the facilitators appreciated them.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt confident the facilitators could help them if needed.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Working Alliance Inventory (WAI)
Time Frame: 9 weeks
|
Question from the WAI bond sub-scale asking participants how often they felt their relationship with the facilitators was very important to them.
Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always.
A higher score indicates a higher bond with the facilitator.
|
9 weeks
|
Covid -19 Impact on Physical Activity
Time Frame: Baseline
|
Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active).
The number of participants with reduced physical activity due to COVID-19 is reported.
|
Baseline
|
Covid -19 Impact on Physical Activity
Time Frame: 9 weeks
|
Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active).
The number of participants with reduced physical activity due to COVID-19 is reported.
|
9 weeks
|
Covid -19 Impact on Physical Activity
Time Frame: 26 weeks
|
Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active).
The number of participants with reduced physical activity due to COVID-19 is reported.
|
26 weeks
|
Covid -19 Impact on Physical Activity
Time Frame: 52 weeks
|
Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active).
The number of participants with reduced physical activity due to COVID-19 is reported.
|
52 weeks
|
Number of Participants Completing Qualitative Assessment of Barriers to Intervention
Time Frame: 9 weeks
|
The number of participants completing qualitative, open ended assessments exploring dislikes and barriers to participation in the intervention.
|
9 weeks
|
Number of Participants Completing Qualitative Assessment of Facilitators to Intervention
Time Frame: 9 weeks
|
The number of participants completing qualitative, open ended assessment exploring likes and facilitators to participation in the intervention.
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2019
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
April 16, 2019
First Submitted That Met QC Criteria
April 25, 2019
First Posted (Actual)
April 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1611S99323
- R33AT009110 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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