Skip to main content
Clinical Trials/NCT03114709
NCT03114709
Completed
N/A

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

University of Minnesota3 sites in 1 country30 target enrollmentMarch 27, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Inactivity
Sponsor
University of Minnesota
Enrollment
30
Locations
3
Primary Endpoint
Moderate-Vigorous Physical Activity (MVPA)
Status
Completed
Last Updated
6 years ago

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 through YMCA community facilities.

Detailed Description

Physical inactivity in the United States has become a critical public health concern for all age groups. With a large segment of the population rapidly aging, there is growing interest in ensuring mid to older age adults (50+) stay active and reduce sedentariness, to decrease their morbidity and mortality risk. While older adults are advised to engage in at least 150 minutes/week of moderate to vigorous physical activity (PA), most do not. Specific theory based behavioral strategies have been shown to positively affect health and activity behaviors. There is also emerging evidence that mindfulness based interventions (MBI) may facilitate PA through increased mind-body awareness and self-regulation. However, research for MBIs and physical activity is currently limited, both in quantity and methodological rigor. The broad long-term objective is to optimize physical and sedentary activity levels in middle-older age adults through an integrated mindfulness and behavioral approach scalable for broad dissemination. The University of Minnesota (UMN) will work with the YMCA Greater Twin Cities, a community based organization committed to providing accessible resources to "build healthy spirit, mind and body for all" and making healthy aging a priority. To decrease time between discovery and translation, a two-phase hybrid effectiveness-implementation design will be used. Phase I will address the following: 1) project organization, barrier/facilitator assessment, protocol development, and training; and 2) evaluation of feasibility of project protocols at multiple levels in a randomized pilot study (n=30) of Mindful Movement versus a modified 10 Keys to Health \& Wellbeing educational control using transition milestones. Phase II will address: 1) investigation of the relative effectiveness of Mindful Movement versus control in a full-scale randomized controlled trial (RCT, n=182) using accelerometer based PA at 9 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes) as well as other secondary measures include sedentary activity, quality of life, exercise self-efficacy and expectations, mindfulness, wellbeing, bodily pain, and adverse events; and 2) RCT interpretation by providing contextual data from participants, staff, and organizational leadership. These will include: enrollment, adherence, follow up, and fidelity rates; and perceptions of barriers/facilitators, relevance, practicality, affordability and acceptability. This information will be used to create a toolkit for implementation at other YMCA sites. This project is innovative in that it will be among the first to assess MBIs for enhancing older adults' physical activity in community based settings using a design intended to facilitate and accelerate research translation. Through the UMN and YMCA partnership, there is great potential to develop a sustainable and replicable physical activity intervention with meaningful impact and nationwide reach.

Registry
clinicaltrials.gov
Start Date
March 27, 2018
End Date
February 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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) AND health care provider does not provide clearance
  • Terminal illness
  • Contraindications to mindfulness practice

Outcomes

Primary Outcomes

Moderate-Vigorous Physical Activity (MVPA)

Time Frame: Change score: 9 weeks score - baseline score

Minutes/week spent in ≥10-min bouts of MVPA

Secondary Outcomes

  • Wellbeing-8-item Flourishing Scale(0, 9 weeks)
  • Pain-11 box numerical rating scale(0, 9 weeks)
  • Satisfaction(9 weeks)
  • Intervention Facilitators(Planning phase, 0, 9 weeks)
  • Mindfulness- Mindful Attention Awareness Scale (MAAS), Frieberg Mindfulness Inventory (FMI)(0, 9 weeks)
  • Social Connectedness & Assurance(0, 9 weeks)
  • Physical Activity-International Physical Activity Questionnaire (IPAQ)(0, 9 weeks)
  • Intervention Barriers(Planning phase, 0, 9 weeks)
  • Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) scale(0, 9 weeks)
  • Quality of Life-Euroqol 5D (EQ5D)(0, 9 weeks)
  • Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) scale(0, 9 weeks)

Study Sites (3)

Loading locations...

Similar Trials