NCT07285954

Brief Summary

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:

  1. 1.Recruitment capability and retention rates,
  2. 2.Acceptability and adherence to the intervention,
  3. 3.Feasibility of assessment procedures, and
  4. 4.Preliminary effects on psychological, physiological, and behavioral outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
45mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2025Dec 2029

Study Start

First participant enrolled

June 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

October 16, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Walking meditationEmotional regulationEEG

Outcome Measures

Primary Outcomes (6)

  • Connor Davidson Resilience Scale for Adults (CD-RISC 25)

    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)

    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

    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

    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

    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

    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.

Study Arms (3)

iWalk Program

ACTIVE COMPARATOR

This group receives the complete iWalk program.

Behavioral: iWalk Program

Education Only without Walking Mindfulness Practice

ACTIVE COMPARATOR

This group receives only education part of the iWalk program without walking mindfulness sessions.

Behavioral: iWalk Program

Control Group

NO INTERVENTION

This group does not receive any intervention and are placed on a waiting list.

Interventions

iWalk ProgramBEHAVIORAL

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.

Education Only without Walking Mindfulness PracticeiWalk Program

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who cannot speak, read, write, or listen in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Neurodegenerative DiseasesEmotional Regulation

Condition Hierarchy (Ancestors)

Nervous System DiseasesSelf-ControlSocial BehaviorBehavior

Central Study Contacts

Chung-Yi Chiu

CONTACT

Vaishnavi Sridharan

CONTACT

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

Study Record Dates

First Submitted

October 16, 2025

First Posted

December 16, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations