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Clinical Trials/NCT03929393
NCT03929393CompletedNot Applicable

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

University of Minnesota10 sites in 1 country176 target enrollmentStarted: July 17, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
176
Locations
10
Primary Endpoint
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Quality of Life - EuroQol VAS(Change score: 52 weeks - baseline)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale(Change score: 52 weeks - baseline)
  • Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts(Change score: 52 weeks - baseline)
  • Average Daily Step Count(Change score: 52 weeks - baseline)
  • Quality of Life - Euroqol 5D (EQ5D)(Change score: 52 weeks - baseline)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale(Change score: 52 weeks - baseline)
  • Social Connectedness(Change score: 52 weeks - baseline)
  • Covid -19 Impact on Physical Activity(52 weeks)
  • Mindfulness - Frieberg Mindfulness Inventory (FMI)(Change score: 52 weeks - baseline)
  • Wellbeing-8-item Flourishing Scale(Change score: 52 weeks - baseline)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(Change score: 52 weeks - baseline)
  • Number of Participants Completing Qualitative Assessment of Barriers to Intervention(9 weeks)
  • Total Moderate-Vigorous Physical Activity (MVPA)(Change score: 52 weeks - baseline)
  • Sedentary Activity(Change score: 52 weeks - baseline)
  • Frequency of Home Practice(52 weeks)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale(Change score: 52 weeks - baseline)
  • Mindfulness - Mindful Attention Awareness Scale (MAAS)(Change score: 52 weeks - baseline)
  • Social Assuredness(Change score: 52 weeks - baseline)
  • Satisfaction With Intervention(52 weeks)
  • Number of Participants Completing Qualitative Assessment of Facilitators to Intervention(9 weeks)
  • Pain-11 Box Numerical Rating Scale(Change score: 52 weeks - baseline)
  • Telehealth Usability Questionnaire(9 weeks)
  • Working Alliance Inventory (WAI)(9 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (10)

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