- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285954
Mindfulness Walking Intervention to Enhance Resilience (iWalk) (iWalk)
A Randomized Controlled Trial of a Walking Meditation Intervention (iWalk) to Enhance Resilience in Adults
This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS).
The objectives are to evaluate:
- Recruitment capability and retention rates,
- Acceptability and adherence to the intervention,
- Feasibility of assessment procedures, and
- Preliminary effects on psychological, physiological, and behavioral outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The iWalk Program is an 8-week, multi-component behavioral intervention integrating mindfulness-based stress reduction and walking meditation to promote resilience and self-regulation in people with MS. The intervention combines weekly educational content, guided walking meditation, and group reflection delivered both in-person and virtually. Participants in the experimental group will attend three one-hour sessions per week (two via Zoom, one in-person) focusing on mindfulness, interoception, emotional regulation, and positive coping.
The waitlist control group will receive usual care during the trial period and will be offered participation after study completion.
Assessments include psychological questionnaires, electroencephalography (EEG), cognitive tasks, balance testing, and physical activity monitoring using Fitbit and Hexoskin wearable sensors. Data analysis includes assessing quantitative and qualitative changes in resilience, stress, mindfulness, mood, interoceptive awareness, quality of life, and physical activity over 8 weeks.
The total study duration is 10 weeks per participant, including baseline and post-intervention assessments.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chung-Yi Chiu
- Phone Number: 12172446435
- Email: chiucy@illinois.edu
Study Contact Backup
- Name: Vaishnavi Sridharan
- Email: vs35@illinois.edu
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- Recruiting
- University of Illinois Urbana-Champaign
-
Contact:
- Chung-Yi Chiu
- Phone Number: 217-244-6435
- Email: chiucy@illinois.edu
-
Contact:
- Email: chiucy@illinois.edu
-
Principal Investigator:
- Chung-Yi Chiu, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older,
- clinical diagnosis of a neurodegenerative disease such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, stroke, etc.,
- have not practiced meditation regularly (e.g., 10 mins per day) and have never attended any meditation classes or community programs,
- never received meditation training via coaching/certification/life coaching,
- have internet access,
- with no severe cognitive impairment, i.e., have a score of ≥ 21 on Modified Telephonic Interview for Cognitive Status (TICS-M),
- be able to walk with or without an assistive device (Patient determined Disease Steps score ranged from 0-6),
- are willing to be randomized to an intervention or a control group,
- are willing to wear Fitbit (a wrist smart watch) for eight weeks,
- are individuals who are right-handed according to the Edinburgh Handedness Questionnaire,
- are willing to participate in all assessments, including in-person testing using electroencephalography (EEG) and cognitive tests, online survey/questionnaires, and online interviews or focus group discussions,
- are willing to wear a Hexoskin t-shirt, which is a heart rate variability monitor, while doing the assessments in person.
Exclusion Criteria:
Participants who cannot speak, read, write, or listen in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: iWalk Program
This group receives the complete iWalk program.
|
A multi-component behavioral program integrating walking meditation, education, and group sessions to enhance resilience and stress regulation in adults with and without chronic conditions.
|
|
Active Comparator: Education Only without Walking Mindfulness Practice
This group receives only education part of the iWalk program without walking mindfulness sessions.
|
A multi-component behavioral program integrating walking meditation, education, and group sessions to enhance resilience and stress regulation in adults with and without chronic conditions.
|
|
No Intervention: Control Group
This group does not receive any intervention and are placed on a waiting list.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Connor Davidson Resilience Scale for Adults (CD-RISC 25)
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
|
Multiple Sclerosis Resilience Scale (MSRS)
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
|
Stroop Task
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
|
Symbol Digit Modalities Test
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
|
Wisconsin Card Sorting Test
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
|
Sustained Attention to Response Task
Time Frame: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB25-0202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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