Mindfulness Walking Intervention to Enhance Resilience (iWalk)

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: EEG; Mindfulness; Adults; Neurodegenerative Disease

Treatments: Behavioral: iWalk Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07285954

IRB25-0202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

iWalk Program

Active Comparator group

Description:

This group receives the complete iWalk program.

Treatment:

Behavioral: iWalk Program

Education Only without Walking Mindfulness Practice

Active Comparator group

Description:

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

Treatment:

Behavioral: iWalk Program

Control Group

No Intervention group

Description:

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