Mindful Walking Intervention for Physical Inactivity

NCT04277026 | Completed

• 1 other identifier: Pro00092710
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Change in perceived 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

  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

  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

  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

  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 (5)

• Demographic Information

  Assessed at pre-intervention/baseline

• Satisfaction with treatment

  Administered at 4 weeks for experimental group and 8 weeks for control group.

• Adverse childhood experiences

  First 18 years of life

Study Arms (2)

Mindful Walking

EXPERIMENTAL

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

Control

NO INTERVENTION

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

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.

Mindful Walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Clemson University: lead
• YMCA: collaborator
• Prisma Health-Upstate: collaborator

Study Sites (3)

Clemson University

Clemson, South Carolina, 29634, United States

Location

Caine Halter Family YMCA

Greenville, South Carolina, 296012, United States

Location

Prisma Health-Upstate Internal Medicine Clinic

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lu Shi, PhD

  Clemson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial with a waitlist control group

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 20, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 5, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)