Physical InactivityNCT03114709
Mindful Movement for Physical Activity and Wellbeing in Older Adults
A study testing Mindful Movement and 10 Keys to Health & Wellbeing in people with Physical Inactivity, run by University of Minnesota at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Mindful Movement and 10 Keys to Health & Wellbeing
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Mar 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
YMCA Southdale
Edina, Minnesota, 55435
University of Minnesota
Minneapolis, Minnesota, 55455
YMCA Midway
Saint Paul, Minnesota, 55104
About this study
Official title: Mindful Movement for Physical Activity and Wellbeing in Older Adults: A Community Based Randomized Hybrid Effectiveness-Implementation Study
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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Mindful Movement, 10 Keys to Health & Wellbeing
- Keywords
- Mindfulness, Exercise, Physical activity, Behavior change, Aging, Randomized controlled trial, Pilot
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful MovementOther
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 support in mindfulness practices and physical activity.
10 Keys to Health & WellbeingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Movement | Experimental | 8, 90-minute, in-person, group sessions over 8 weeks Receives: Other: Mindful Movement |
| 10 Keys to Health & Wellbeing | Active comparator | 8, 90-minute, in-person, group sessions over 8 weeks Receives: Other: 10 Keys to Health & Wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-Vigorous Physical Activity (MVPA)
Minutes/week spent in ≥10-min bouts of MVPA
Measured: Change score: 9 weeks score - baseline score
Secondary outcomes (11)
Quality of Life-Euroqol 5D (EQ5D)
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).
Measured: 0, 9 weeks
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) scale
Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident).
Measured: 0, 9 weeks
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) scale
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).
Measured: 0, 9 weeks
Mindfulness- Mindful Attention Awareness Scale (MAAS), Frieberg Mindfulness Inventory (FMI)
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).
Measured: 0, 9 weeks
Wellbeing-8-item Flourishing Scale
This scale assesses perceived success in relationships, self-esteem, and purpose.
Measured: 0, 9 weeks
Pain-11 box numerical rating scale
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.
Measured: 0, 9 weeks
Social Connectedness & Assurance
This includes two, eight-item questionnaires with a six-item scale (strongly agree, strongly disagree).
Measured: 0, 9 weeks
Physical Activity-International Physical Activity Questionnaire (IPAQ)
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.
Measured: 0, 9 weeks
Satisfaction
Participants will rate their overall satisfaction (satisfied, completely dissatisfied) with the intervention.
Measured: 9 weeks
Intervention Barriers
This qualitative, open ended assessment explores barriers to participation in the intervention.
Measured: Planning phase, 0, 9 weeks
Intervention Facilitators
This qualitative, open ended assessment explores facilitators to participation in the intervention.
Measured: Planning phase, 0, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start27 Mar 2018
- Primary completion31 Aug 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Roni Evans, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114709
- Sponsor's protocol ID
- 1611S99323-2
- Other IDs
- R21AT009110
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be provided in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Movement for Physical Activity and Wellbeing in Older Adults: A Community Based Randomized Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT03114709
- Acronym / sponsor ID
- 1611S99323-2
- Conditions
- Physical Inactivity
- Keywords
- Mindfulness, Exercise, Physical activity, Behavior change, Aging, Randomized controlled trial, Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- YMCA, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Movement | Experimental | Other: Mindful Movement8, 90-minute, in-person, group sessions over 8 weeks |
| 10 Keys to Health & Wellbeing | Active comparator | Other: 10 Keys to Health & Wellbeing8, 90-minute, in-person, group sessions over 8 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful MovementThe 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 support in mindfulness practices and physical activity. | Other | Mindful Movement |
| 10 Keys to Health & WellbeingThis 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. | Other | 10 Keys to Health & Wellbeing |
Primary outcome
Moderate-Vigorous Physical Activity (MVPA)
Time frame: Change score: 9 weeks score - baseline score
Minutes/week spent in ≥10-min bouts of MVPA
11 secondary outcomes
Quality of Life-Euroqol 5D (EQ5D)
Time frame: 0, 9 weeks
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) scale
Time frame: 0, 9 weeks
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) scale
Time frame: 0, 9 weeks
Mindfulness- Mindful Attention Awareness Scale (MAAS), Frieberg Mindfulness Inventory (FMI)
Time frame: 0, 9 weeks
Wellbeing-8-item Flourishing Scale
Time frame: 0, 9 weeks
Pain-11 box numerical rating scale
Time frame: 0, 9 weeks
Social Connectedness & Assurance
Time frame: 0, 9 weeks
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time frame: 0, 9 weeks
Satisfaction
Time frame: 9 weeks
Intervention Barriers
Time frame: Planning phase, 0, 9 weeks
Intervention Facilitators
Time frame: Planning phase, 0, 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No. Data will be provided in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni Evans, PhD principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Movement and 10 Keys to Health & Wellbeing in people with Physical Inactivity, run by University of Minnesota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-Vigorous Physical Activity (MVPA) (time frame: Change score: 9 weeks score - baseline score). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.