Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study

Not Applicable

Completed

• Conditions: Wellbeing; Physical Inactivty; Mindfulness
• Interventions: Other: Keys to Health & Wellbeing; Behavioral: Mindful Movement

• Registration Number: NCT03929393
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Study Start: 2019-07-17
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Results First Submitted: 2023-04-11
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Results First Posted: 2023-07-21
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keys to Health & Wellbeing	Keys to Health & Wellbeing	8, 90-minute, in-person, group sessions over 8 weeks
Mindful Movement	Mindful Movement	8, 90-minute, in-person, group sessions over 8 weeks

Primary Outcome Measures

Name	Time	Method
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts	Change score: 9 weeks - baseline	Minutes/week spent in ≥10-min bouts of MVPA

Secondary Outcome Measures

Name	Time	Method
Quality of Life - EuroQol VAS	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.
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale	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.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts	Change score: 52 weeks - baseline	Minutes/week spent in ≥10-min bouts of MVPA
Average Daily Step Count	Change score: 52 weeks - baseline	Average steps/day over one week
Quality of Life - Euroqol 5D (EQ5D)	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.
Social Connectedness	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.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale	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.
Covid -19 Impact on Physical Activity	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.
Mindfulness - Frieberg Mindfulness Inventory (FMI)	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.
Wellbeing-8-item Flourishing Scale	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.
Physical Activity-International Physical Activity Questionnaire (IPAQ)	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.
Working Alliance Inventory (WAI)	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.
Number of Participants Completing Qualitative Assessment of Barriers to Intervention	9 weeks	The number of participants completing qualitative, open ended assessments exploring dislikes and barriers to participation in the intervention.
Total Moderate-Vigorous Physical Activity (MVPA)	Change score: 52 weeks - baseline	Minutes/week spent in MVPA
Sedentary Activity	Change score: 52 weeks - baseline	Time spent in sedentary activity
Frequency of Home Practice	52 weeks	Participants will report the number of days per week they were able to practice skills taught in the program
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale	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.
Mindfulness - Mindful Attention Awareness Scale (MAAS)	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.
Social Assuredness	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.
Satisfaction With Intervention	52 weeks	Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
Number of Participants Completing Qualitative Assessment of Facilitators to Intervention	9 weeks	The number of participants completing qualitative, open ended assessment exploring likes and facilitators to participation in the intervention.
Pain-11 Box Numerical Rating Scale	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.
Telehealth Usability Questionnaire	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.

Trial Locations

Locations (5)

YMCA Southdale; 🇺🇸 Edina, Minnesota, United States

YMCA Burnsville; 🇺🇸 Burnsville, Minnesota, United States

YMCA Cora McCorvey; 🇺🇸 Minneapolis, Minnesota, United States

YMCA Midway; 🇺🇸 Saint Paul, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States