Идёт набор NCT07285954

Mindfulness Walking Intervention to Enhance Resilience (iWalk)

Без фазы С лечением Neurodegenerative Disease EEG Mindfulness Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: iWalk Program.
Кому может быть актуально: Состояния в реестре: Neurodegenerative Disease, EEG, Mindfulness, Adults. Базовые параметры: 18 лет — 110 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Controlled Trial of a Walking Meditation Intervention (iWalk) to Enhance Resilience in Adults

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Connor Davidson Resilience Scale for Adults (CD-RISC 25) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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.