- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277026
Mindful Walking Intervention for Physical Inactivity
March 6, 2024 updated by: Heidi Zinzow, Clemson University
Mindfulness Training for Adults With Physical Inactivity
Mindful walking is a meditation practice that combines physical activity and mindfulness practice.
The purpose of this study is to examine the effectiveness of mindfulness-based interventions provided for increasing physical activity among adults with low physical activity levels.
A randomized controlled trial design will be utilized, with an intervention and waitlist control group (N = 160).
Outcomes measured include physical activity, sleep quality, and functional fitness.
Participants will receive a total of eight sessions of 60-minute mindful walking training within four weeks.
The intervention group will receive the training in Weeks 1-4 and the control group will receive the training during Weeks 5-8.
Each training group will consist of up to 20 individuals.
Data will be collected at baseline, four weeks, and eight weeks to determine the efficacy of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Clemson, South Carolina, United States, 29634
- Clemson University
-
Greenville, South Carolina, United States, 296012
- Caine Halter Family YMCA
-
Greenville, South Carolina, United States, 29605
- Prisma Health-Upstate Internal Medicine Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18 and above
- English speaking
- Literacy 6th grade and above
- Willingness to share contact information (home address, phone number)
- No current mindfulness practice
- Greenville residents or persons who are patients of the partnering organizations in the investigator's study.
- Self-reported physical activity level below the CDC recommended guidelines (150 minutes (2 hours and 30 minutes) a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes ) a week of vigorous-intensity aerobic activity, or an equivalence combination of moderate- and vigorous intensity aerobic activity
Exclusion Criteria:
- <18 years old
- Non-English-speaking
- Literacy lower than 6th grade
- Inability to attend intervention sessions
- Already completed or attending a mindfulness-based intervention
- Current pregnancy
- Current/past psychosis
- Acute episode of a substance use disorder (past two weeks)
- Acute episode of depression in the past two weeks
- Moderate to severe traumatic brain injury or brain damage
- Persistent antisocial behavior
- Persistent self-injury requiring clinical management
- Unable to engage for physical or practical reasons (e.g., disabling physical problems, unable to comprehend material)
- Dementia
- Suicidality
- Inability to do light walking for 10 mins at a stretch
- Severely obese BMI (>50 kg/m2)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindful Walking
Eight weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath.
Discussion of mindful walking experiences and encouragement to meet physical activity goals.
The intervention will take place two times per week for four weeks (Weeks 1-4).
During weeks 5-8 the experimental group will continue treatment as usual and will not be receiving the mindful walking intervention.
|
Eight weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath.
Discussion of mindful walking experiences and encouragement to meet physical activity goals.
|
No Intervention: Control
Participants will engage in treatment as usual during the first four weeks and will not be receiving the experimental intervention (mindful walking) during weeks 1-4.
After the experimental group completes the mindful walking intervention, the control group will complete the mindful walking intervention (weeks 5-8).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity
Time Frame: Scale administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Rapid Assessment of Physical Activity Scale: self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity
|
Scale administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in muscle strength
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Upper and lower muscle strength will be measured with the 30-second arm curl test (number of biceps curls completed while holding a hand weight of 2.27 kg for women and 3.63 kg for men) and the 30-second chair-stand test (Prakhinkit et al. 2014).
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in sleep quality
Time Frame: Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Pittsburgh Sleep Quality Index: 19 item self-report measure assessing sleep quality over the past month, total score ranging from 0 to 21, with higher scores indicating worse sleep quality
|
Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in flexibility
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
The back scratch flexibility test (how close the hands can be brought together behind the back) and the chair sit-and-reach test will be used to measure upper and lower limb flexibility, respectively (Prakhinkit et al. 2014).
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in agility
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
The timed up-and-go test will be used as a measure of agility (Prakhinkit et al. 2014)
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in dynamic balance
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
The Star Excursion Balance Test will measure dynamic balance (Gribble, Hertel, and Plisky 2012)
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in cardiorespiratory endurance
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
6 minute walk test, measure includes how many meters the individual walks in 6 minutes around a 50-yard course (Prakhinkit et al. 2014)
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceived stress
Time Frame: Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Perceived Stress Scale: 4 item self-report measure assessing perceived stress over the past month, total score ranges from 4 to 20, higher levels indicating higher levels of stress
|
Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in adherence to medications
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Adherence to Refills and Medications Scale: 12 item self-report scale assesses adherence to other medication treatments; scores range from 12-34, where lower scores indicate better adherence (adherence to medications not given as part of this study) (Kripalani et al. 2009)
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in mindfulness skills
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
The Five Facet Mindfulness Questionnaire: 39 self-report items assessing five dimensions of mindfulness.
Items are rated on a 5 point scale ranging from 1 to 5, with total score ranging from 39 to 195.
Higher scores indicate greater dispositional tendency to be mindful in daily life (e.g., observing, describing, acting with awareness, nonjudging of inner experience, nonreactivity to inner experiences).
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Change in executive functioning
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Executive Function Index: A 27-item self-report inventory assessing five facets of executive functioning (Spinella, 2005); Items rated "how well the following statement describes me" 1 (not at all) to 5 (very much), range 27-135 with higher scores indicating higher levels of executive functioning.
|
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Mindfulness practice behavior
Time Frame: Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Additional mindfulness practices engaged in outside of the study sessions over the past month, assessed with four self-report items: 'Did you engage in mindfulness meditation in the past month?',
'How many days per week did you engage in mindfulness meditation?', 'How long in minutes did you meditate per session of mindfulness meditation?', 'Describe your practice of mindfulness meditation (what exercises/activities/techniques did you practice?)
|
Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Information
Time Frame: Assessed at pre-intervention/baseline
|
Age, race, ethnicity, marital status, language spoken, highest level of education, employment status, annual household income, health insurance, current smoking
|
Assessed at pre-intervention/baseline
|
Satisfaction with treatment
Time Frame: Administered at 4 weeks for experimental group and 8 weeks for control group.
|
Treatment Satisfaction Survey (Zgierska et al. 2008), 5 item self-report measure, qualitative and quantitative items with quantitative scale ranging from 0 to 16, with higher scores indicating greater satisfaction with mindfulness intervention
|
Administered at 4 weeks for experimental group and 8 weeks for control group.
|
Adverse childhood experiences
Time Frame: First 18 years of life
|
Adverse Childhood Experiences Questionnaire: 10 item self-report scale assesses adverse events in the first 18 years of life (Felitti, 1998).
Scores range from 0 to 10, with higher scores indicating greater number or adverse events.
|
First 18 years of life
|
Traumatic event history
Time Frame: Assessed at pre-intervention/baseline
|
Life Events Checklist for DSM-5: 17 self-report items that assess a number of different types of traumatic events across the lifespan and personal occurrence versus learning about a traumatic event (Weathers et al., 2013).
There is no formal scoring protocol, although endorsing 1 or more items indicates lifetime exposure to a traumatic event.
|
Assessed at pre-intervention/baseline
|
Use of psychological services
Time Frame: Assessed at pre-intervention/baseline
|
The Adult Service Use Schedule: Fifteen open-ended, self-report items assessing use of psychological services, accessibility, and length of service use (Bower et al., 2000).
|
Assessed at pre-intervention/baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lu Shi, PhD, Clemson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
November 5, 2023
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (Actual)
February 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Pro00092710
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared outside the research team
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Inactivity
-
University of Alabama at BirminghamRecruitingDisability Physical | Physical InactivityUnited States
-
University of IowaNational Institute on Aging (NIA); Northeastern UniversityNot yet recruiting
-
Ludwig Boltzmann Institute for Digital Health and...RecruitingPhysical InactivityAustria
-
University of MichiganNational Institute on Aging (NIA)Recruiting
-
University of MinnesotaRecruitingPhysical InactivityUnited States
-
Brown UniversityNational Cancer Institute (NCI)Recruiting
-
Universiti Putra MalaysiaRecruitingInactivity, PhysicalPakistan
-
University of Milano BicoccaFederico II University; University of BergamoRecruitingPhysical InactivityItaly
-
University of CalgaryPublic Health Agency of Canada (PHAC)Recruiting
-
Brown UniversityNational Institute of General Medical Sciences (NIGMS)CompletedPhysical InactivityUnited States
Clinical Trials on Mindful Walking
-
Clemson UniversityCompleted
-
University of South CarolinaCenters for Disease Control and PreventionRecruitingCognitive Function | Behavior, Health | Aging WellUnited States
-
Charite University, Berlin, GermanyCompleted
-
University of Illinois at ChicagoRecruitingStress, Psychological | Cognitive DeclineUnited States
-
Chang Gung Memorial HospitalRecruitingSchizophrenia | Exercise | ConditionTaiwan
-
Clemson UniversityRecruiting
-
Swansea UniversityMedical University of South Carolina; Charles University, Czech Republic; Radboud... and other collaboratorsCompletedControl Condition | Body Scan Meditation | Loving-Kindness Meditation | Mindful Breathing Meditation | Mindful Walking MeditationUnited Kingdom
-
National Institute of Nursing Research (NINR)TerminatedHealthy | Obesity | AdultUnited States
-
National University of SingaporeCompletedStress | AnxietySingapore
-
Beth Israel Deaconess Medical CenterRecruitingMetabolic SyndromeUnited States