Mindfulness Walking Intervention to Enhance Resilience (iWalk)

NCT ID: NCT07285954

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Neurodegenerative Disease EEG Mindfulness Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iWalk Program

This group receives the complete iWalk program.

Group Type ACTIVE_COMPARATOR

iWalk Program

Intervention Type BEHAVIORAL

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 Practice

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

Group Type ACTIVE_COMPARATOR

iWalk Program

Intervention Type BEHAVIORAL

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older,
2. clinical diagnosis of a neurodegenerative disease such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, stroke, etc.,
3. have not practiced meditation regularly (e.g., 10 mins per day) and have never attended any meditation classes or community programs,
4. never received meditation training via coaching/certification/life coaching,
5. have internet access,
6. with no severe cognitive impairment, i.e., have a score of ≥ 21 on Modified Telephonic Interview for Cognitive Status (TICS-M),
7. be able to walk with or without an assistive device (Patient determined Disease Steps score ranged from 0-6),
8. are willing to be randomized to an intervention or a control group,
9. are willing to wear Fitbit (a wrist smart watch) for eight weeks,
10. are individuals who are right-handed according to the Edinburgh Handedness Questionnaire,
11. 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,
12. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Chung-Yi Chiu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Illinois Urbana-Champaign

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chung-Yi Chiu

Role: CONTACT

12172446435

Vaishnavi Sridharan

Role: CONTACT

Facility Contacts

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Chung-Yi Chiu

Role: primary

217-244-6435

Role: backup

Other Identifiers

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IRB25-0202

Identifier Type: -

Identifier Source: org_study_id