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CompletedNCT04277026Updated Mar 8, 2024

Mindful Walking Intervention for Physical Inactivity

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

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Physical Inactivity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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.

    Behavioral: Mindful Walking

  • 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).

Interventions

  • BehavioralMindful 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.

05

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Other outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

06

Study locations

3 sites
  • Clemson University
    Clemson, South Carolina 29634, United States
  • Caine Halter Family YMCA
    Greenville, South Carolina 296012, United States
  • Prisma Health-Upstate Internal Medicine Clinic
    Greenville, South Carolina 29605, United States
07

References and documents

Individual participant data

Plan to share: No — IPD will not be shared outside the research team

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04277026
Lead sponsor
Clemson University
Collaborators
YMCA, Prisma Health-Upstate
Responsible party
Heidi Zinzow (Associate Professor, Clemson University) — Principal investigator
First posted
Feb 20, 2020
Start date
Mar 1, 2020
Primary completion
Nov 1, 2023
Completion
Nov 5, 2023
Last update
Mar 8, 2024

Study contacts

Lu Shi, PhD
principal investigator · Clemson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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