Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929393
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
YMCA
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 Intervention/treatment Phase
Physical Inactivty Wellbeing Mindfulness Behavioral: Mindful Movement Other: Keys to Health & Wellbeing Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 17, 2019
Estimated Primary Completion Date : March 13, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929393


Contacts
Layout table for location contacts
Contact: Linda Hanson 6123019009 hans4236@umn.edu
Contact: John Jodzio 6123019006 jodz0001@umn.edu

Locations
Layout table for location information
United States, Minnesota
YMCA Burnsville Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Linda Hanson    612-301-9009    hans4236@umn.edu   
Contact: John Jodzio    6123019006    jodz0001@umn.edu   
YMCA Southdale Recruiting
Edina, Minnesota, United States, 55435
Contact: Linda Hanson    612-301-9009    hans4236@umn.edu   
Contact: John Jodzio    612-301-9006    jodz0001@umn.edu   
YMCA Cora McCorvey Recruiting
Minneapolis, Minnesota, United States, 55405
Contact: Linda Hanson    612-301-9009    hans4236@umn.edu   
Contact: John Jodzio    612-301-9006    jodz0001@umn.edu   
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Linda Hanson    612-301-9009    hans4236@umn.edu   
Contact: John Jodzio    612-301-9006    jodzio0001@umn.edu   
Principal Investigator: Roni L Evans, PhD, DC, MS         
YMCA Midway Recruiting
Saint Paul, Minnesota, United States, 55104
Contact: Linda Hanson    612-301-9009    hans4236@umn.edu   
Contact: John Jodzio    612-301-9006    jodz0001@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
YMCA

Additional Information:
Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03929393     History of Changes
Other Study ID Numbers: R33AT009110 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Randomized controlled trial
Exercise
Physical Activity
Behavior Change
Mindfulness
Aging