Mindful Walking Intervention for Physical Inactivity

Physical Inactivity Clinical Trial

Official title:

Mindfulness Training for Adults With Physical Inactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277026
• Other study ID #: Pro00092710
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 5, 2023

Study information

• Verified date: March 2024
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 5, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Clemson University	Clemson	South Carolina
United States	Caine Halter Family YMCA	Greenville	South Carolina
United States	Prisma Health-Upstate Internal Medicine Clinic	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Clemson University	Prisma Health-Upstate, YMCA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic Information	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
Other	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	Administered at 4 weeks for experimental group and 8 weeks for control group.
Other	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.	First 18 years of life
Other	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.	Assessed at pre-intervention/baseline
Other	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).	Assessed at pre-intervention/baseline
Primary	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	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)
Primary	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).	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)
Primary	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	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)
Primary	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).	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)
Primary	Change in agility	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)
Primary	Change in dynamic balance	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)
Primary	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)	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	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	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	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)	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	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).	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	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.	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	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?)	Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)