Clinical trial NCT03929393: Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study
Official title: Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivty
Wellbeing
Mindfulness
Keywords: Randomized controlled trial
Exercise
Physical Activity
Behavior Change
Mindfulness
Aging
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: YMCA
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-04-26
Enrollment: 176
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
timeFrame: Baseline
measure: Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
timeFrame: Change score: 9 weeks - baseline
Secondary outcomes:
measure: Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
timeFrame: Change score: 26 weeks - baseline
measure: Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
timeFrame: Change score: 52 weeks - baseline
measure: Total Moderate-Vigorous Physical Activity (MVPA)
timeFrame: Baseline
measure: Total Moderate-Vigorous Physical Activity (MVPA)
timeFrame: Change score: 9 weeks - baseline
measure: Total Moderate-Vigorous Physical Activity (MVPA)
timeFrame: Change score: 26 weeks - baseline
measure: Total Moderate-Vigorous Physical Activity (MVPA)
timeFrame: Change score: 52 weeks - baseline
measure: Sedentary Activity
timeFrame: Baseline
measure: Sedentary Activity
timeFrame: Change score: 9 weeks - baseline
measure: Sedentary Activity
timeFrame: Change score: 26 weeks - baseline
measure: Sedentary Activity
timeFrame: Change score: 52 weeks - baseline
measure: Average Daily Step Count
timeFrame: Baseline
measure: Average Daily Step Count
timeFrame: Change score: 9 weeks - baseline
measure: Average Daily Step Count
timeFrame: Change score: 26 weeks - baseline
measure: Average Daily Step Count
timeFrame: Change score: 52 weeks - baseline
measure: Quality of Life - Euroqol 5D (EQ5D)
timeFrame: Baseline
measure: Quality of Life - Euroqol 5D (EQ5D)
timeFrame: Change score: 9 weeks - baseline
measure: Quality of Life - Euroqol 5D (EQ5D)
timeFrame: Change score: 26 weeks - baseline
measure: Quality of Life - Euroqol 5D (EQ5D)
timeFrame: Change score: 52 weeks - baseline
measure: Quality of Life - EuroQol VAS
timeFrame: Baseline
measure: Quality of Life - EuroQol VAS
timeFrame: Change score: 9 weeks - baseline
measure: Quality of Life - EuroQol VAS
timeFrame: Change score: 26 weeks - baseline
measure: Quality of Life - EuroQol VAS
timeFrame: Change score: 52 weeks - baseline
measure: Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
timeFrame: Baseline
measure: Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
timeFrame: Change score: 9 weeks - baseline
measure: Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
timeFrame: Change score: 26 weeks - baseline
measure: Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
timeFrame: Change score: 52 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
timeFrame: Baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
timeFrame: Change score: 9 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
timeFrame: Change score: 26 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
timeFrame: Change score: 52 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
timeFrame: Baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
timeFrame: Change score: 9 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
timeFrame: Change score: 26 weeks - baseline
measure: Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
timeFrame: Change score: 52 weeks - baseline
measure: Mindfulness - Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline
measure: Mindfulness - Mindful Attention Awareness Scale (MAAS)
timeFrame: Change score: 9 weeks - baseline
measure: Mindfulness - Mindful Attention Awareness Scale (MAAS)
timeFrame: Change score: 26 weeks - baseline
measure: Mindfulness - Mindful Attention Awareness Scale (MAAS)
timeFrame: Change score: 52 weeks - baseline
measure: Mindfulness - Frieberg Mindfulness Inventory (FMI)
timeFrame: Baseline
measure: Mindfulness - Frieberg Mindfulness Inventory (FMI)
timeFrame: Change score: 9 weeks - baseline
measure: Mindfulness - Frieberg Mindfulness Inventory (FMI)
timeFrame: Change score: 26 weeks - baseline
measure: Mindfulness - Frieberg Mindfulness Inventory (FMI)
timeFrame: Change score: 52 weeks - baseline
measure: Wellbeing-8-item Flourishing Scale
timeFrame: Baseline
measure: Wellbeing-8-item Flourishing Scale
timeFrame: Change score: 9 weeks - baseline
measure: Wellbeing-8-item Flourishing Scale
timeFrame: Change score: 26 weeks - baseline
measure: Wellbeing-8-item Flourishing Scale
timeFrame: Change score: 52 weeks - baseline
measure: Social Connectedness
timeFrame: Baseline
measure: Social Connectedness
timeFrame: Change score: 9 weeks - baseline
measure: Social Connectedness
timeFrame: Change score: 26 weeks - baseline
measure: Social Connectedness
timeFrame: Change score: 52 weeks - baseline
measure: Social Assuredness
timeFrame: Baseline
measure: Social Assuredness
timeFrame: Change score: 9 weeks - baseline
measure: Social Assuredness
timeFrame: Change score: 26 weeks - baseline
measure: Social Assuredness
timeFrame: Change score: 52 weeks - baseline
measure: Physical Activity-International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: Physical Activity-International Physical Activity Questionnaire (IPAQ)
timeFrame: Change score: 9 weeks - baseline
measure: Physical Activity-International Physical Activity Questionnaire (IPAQ)
timeFrame: Change score: 26 weeks - baseline
measure: Physical Activity-International Physical Activity Questionnaire (IPAQ)
timeFrame: Change score: 52 weeks - baseline
measure: Satisfaction With Intervention
timeFrame: 9 weeks
measure: Satisfaction With Intervention
timeFrame: 26 weeks
measure: Satisfaction With Intervention
timeFrame: 52 weeks
measure: Frequency of Home Practice
timeFrame: 9 weeks
measure: Frequency of Home Practice
timeFrame: 26 weeks
measure: Frequency of Home Practice
timeFrame: 52 weeks
measure: Pain-11 Box Numerical Rating Scale
timeFrame: Baseline
measure: Pain-11 Box Numerical Rating Scale
timeFrame: Change score: 9 weeks - baseline
measure: Pain-11 Box Numerical Rating Scale
timeFrame: Change score: 26 weeks - baseline
measure: Pain-11 Box Numerical Rating Scale
timeFrame: Change score: 52 weeks - baseline
measure: Telehealth Usability Questionnaire
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 9 weeks
measure: Covid -19 Impact on Physical Activity
timeFrame: Baseline
measure: Covid -19 Impact on Physical Activity
timeFrame: 9 weeks
measure: Covid -19 Impact on Physical Activity
timeFrame: 26 weeks
measure: Covid -19 Impact on Physical Activity
timeFrame: 52 weeks
measure: Number of Participants Completing Qualitative Assessment of Barriers to Intervention
timeFrame: 9 weeks
measure: Number of Participants Completing Qualitative Assessment of Facilitators to Intervention
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Burnsville
country: United States
facility: YMCA Burnsville
state: Minnesota
city: Edina
country: United States
facility: YMCA Southdale
state: Minnesota
city: Minneapolis
country: United States
facility: YMCA Cora McCorvey
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: YMCA Midway
state: Minnesota
Study officials:
References: