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Completed

NCT Number: NCT04277026

Mindful Walking Intervention for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clemson University, Clemson, South Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindful Walking

Behavioral

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.

Primary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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).

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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).

  4. 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.

  5. 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?)

Other outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Collaborators

  • Prisma Health-Upstate
  • YMCA

Registry information

Official study title

Mindfulness Training for Adults With Physical Inactivity

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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