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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03929393

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted November 1, 2019

Study Description

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.

  • Condition or Disease:Mindfulness
    Wellbeing
    Physical Inactivty
  • Intervention/Treatment: Behavioral: Mindful Movement
    Other: Keys to Health & Wellbeing
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 182 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Mindful Movement
8, 90-minute, in-person, group sessions over 8 weeks
Behavioral: Mindful Movement
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
Other: Keys to Health & Wellbeing
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.
Outcome Measures
  • Primary Outcome Measures: 1. Moderate-Vigorous Physical Activity (MVPA) Score [ Time Frame: Change score: baseline - 9 weeks ]
    Minutes/week spent in ≥10-min bouts of MVPA
  • Secondary Outcome Measures: 1. Sedentary activity [ Time Frame: 0, 9, 26, 52 weeks ]
    Time spent in sedentary activity
  • 2. Steps per day [ Time Frame: 0, 9, 26, 52 weeks ]
    Steps per day will be measured.
  • 3. Moderate to Vigorous Physical Activity [ Time Frame: 26, 52 weeks ]
    Minutes/week spent in ≥10-min bouts of MVPA
  • 4. Quality of Life-Euroqol 5D (EQ5D) [ Time Frame: 0, 9, 26, 52 weeks ]
    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).
  • 5. Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) scale [ Time Frame: 0, 9, 26, 52 weeks ]
    Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident).
  • 6. Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) scale [ Time Frame: 0, 9, 26, 52 weeks ]
    This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. Responses range from 1 (strongly agree) to 5 (strongly disagree).
  • 7. Mindfulness- Mindful Attention Awareness Scale (MAAS), Frieberg Mindfulness Inventory (FMI) [ Time Frame: 0, 9, 26, 52 weeks ]
    The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never). The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always).
  • 8. Wellbeing-8-item Flourishing Scale [ Time Frame: 0, 9, 26, 52 weeks ]
    This 8 item scale assesses perceived success in relationships, self-esteem, and purpose. Responses are 7=Strongly Agree to 1=Strongly Disagree. Total score ranges from 8 to 56 (highest level of wellbeing or flourishing).
  • 9. Pain-11 box numerical rating scale [ Time Frame: 0, 9, 26, 52 weeks ]
    An 11-box numerical rating scale (0=no pain, 10=the worst pain possible) will be used for spinal pain, and upper and lower extremities.
  • 10. Social Connectedness & Assurance [ Time Frame: 0, 9, 26, 52 weeks ]
    This includes two, eight-item questionnaires with a six-item scale (1=strongly agree, 6=strongly disagree). Higher summed score indicates more social connectedness, assurance.
  • 11. Physical Activity-International Physical Activity Questionnaire (IPAQ) [ Time Frame: 0, 9, 26, 52 weeks ]
    An adapted, nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days is used to measure physical activity. Reported as continuous variables days/week, minutes/day.
  • 12. Satisfaction: rating [ Time Frame: 9, 26, 52 weeks ]
    Participants will rate their overall satisfaction on 7 point scale (7=completely satisfied, 1= completely dissatisfied) with the intervention.
  • 13. Qualitative Assessment of Barriers to Intervention [ Time Frame: 0, 9, 26, 52 weeks ]
    This qualitative, open ended assessment explores dislikes and barriers to participation in the intervention.Themes will be categorized and described in percentages of participants reporting.
  • 14. Qualitative Assessment of Facilitators to Intervention [ Time Frame: 0, 9, 26, 52 weeks ]
    This qualitative, open ended assessment explores likes and facilitators to participation in the intervention. Themes will be categorized and described in percentages of participants reporting.
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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) - Terminal illness - Contraindications to mindfulness practice

Contacts and Locations
Contacts

Contact: Linda Hanson 6123019009 hans4236@umn.edu

Contact: John Jodzio 6123019006 jodz0001@umn.edu

Locations

United States, Minnesota
YMCA Burnsville
Burnsville

United States, Minnesota
YMCA Southdale
Edina

United States, Minnesota
YMCA Cora McCorvey
Minneapolis

United States, Minnesota
University of Minnesota
Minneapolis

United States, Minnesota
YMCA Midway
Saint Paul

Sponsors and Collaborators

University of Minnesota

YMCA

National Center for Complementary and Integrative Health (NCCIH)

More Information
  • Responsible Party: University of Minnesota
  • ClinicalTrials.gov Identifier: NCT03929393 History of Changes
  • Other Study ID Numbers: 1611S99323, R33AT009110
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: November 1, 2019
  • Last Verified: October 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Minnesota: Randomized controlled trial
    Exercise
    Physical Activity
    Behavior Change
    Mindfulness
    Aging