An interventional study of Mindful Walking in Physical Inactivity, sponsored by Clemson University. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Clemson University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: Mindful Walking
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).
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.
Change in physical activity
Rapid Assessment of Physical Activity Scale: self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased 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)
Change in muscle strength
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).
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)
Change in sleep quality
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
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)
Change in flexibility
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).
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)
Change in agility
The timed up-and-go test will be used as a measure of agility (Prakhinkit et al. 2014)
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)
Change in dynamic balance
The Star Excursion Balance Test will measure dynamic balance (Gribble, Hertel, and Plisky 2012)
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)
Change in cardiorespiratory endurance
6 minute walk test, measure includes how many meters the individual walks in 6 minutes around a 50-yard course (Prakhinkit et al. 2014)
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)
Change in perceived stress
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
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)
Change in adherence to medications
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)
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)
Change in mindfulness skills
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).
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)
Change in executive functioning
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.
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)
Mindfulness practice behavior
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?)
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)
Demographic Information
Age, race, ethnicity, marital status, language spoken, highest level of education, employment status, annual household income, health insurance, current smoking
Time frame: Assessed at pre-intervention/baseline
Satisfaction with treatment
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
Time frame: Administered at 4 weeks for experimental group and 8 weeks for control group.
Adverse childhood experiences
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.
Time frame: First 18 years of life
Traumatic event history
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.
Time frame: Assessed at pre-intervention/baseline
Use of psychological services
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).
Time frame: Assessed at pre-intervention/baseline
Plan to share: No — IPD will not be shared outside the research team
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