MOVIN' CARE for PD (Mind-body Interventions)

NCT06078046 | Active Not Recruiting

• 1 other identifier: EA230262I
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention study is to investigate the effectiveness of two mind-body interventions - yoga, and arts-based approaches in improving the psycho-social-spiritual well-being among PD patients. The hypotheses include: H1: Yoga and arts-based interventions will significantly improve the psycho-social-spiritual well-being among PD patients H2: Yoga and arts-based interventions will significantly alleviate or maintain PD-related symptoms and severity levels H3: There is no significant difference between the effectiveness of yoga and arts-based interventions on psycho-social-spiritual well-being among PD patients Eligible individuals will be invited to a baseline assessment followed by a randomization to the two intervention groups. A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment, to investigate the immediate and long-term effects.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• Change of Perceived stress level

  Perceived Stress Scale (PSS) uses a five-point Likert scale to measure the perceived stress level. The 10 items in the scale can be divided into two subscales, measuring the perceived helplessness, and inadequacy of self-efficacy. The scale ranges from 0-40, with a high score indicates a high perceived stress level. The Cronbach's α of the validated Chinese version of the scale is 0.85.

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of overall Quality of Life assessed by the WHOQOL-BREF

  Overall quality of life will be measured by the WHOQOL-BREF. It will measure the four dimensions of quality of life, including physical health, psychological health, social relationships, and environment. The scale consists of 26 items and uses a five-point Likert scale. The higher the score, the better the quality of life. The Cronbach's α of the subscales ranges from 0.73-0.82.

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of Quality of Life specified to Parkinson's Disease assessed by the PDQ-8

  The validated Chinese version of Parkinson's Disease Questionnaire-8 consists of 8-items and it captures PD-related health-related quality of life (HRQOL) in eight domains, including mobility, activities of daily living, emotional wellbeing, social support, communication, cognition, body discomfort and stigma. A high score indicates worse HRQOL. Cronbach's α is 0.80.

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of PD-related symptoms

  PD-related symptoms will be measured by the validated Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS)(Chinese) Part I to IV \[13\]. The four dimensions measured by the scale include (i) non-motor experiences of daily living, (ii) motor experiences of daily living, (iii) severity of motor symptoms, and (iv) motor complications. High scores indicate great disease severity. Cronbach's α are 0.79-0.94. In addition, Mon4t (by Montfort Brain Monitor, Tel-Aviv, Israel) is a mobile application that evaluates PD-related motor symptoms of participants. It is commonly used for tasks including timed-up-and-go, finger tapping, measuring resting tremor and postural tremor.

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of self-compassion

  Self-compassion will be measured by the 12-items Self-compassion Scale(SCS). Using a five-points Likert scale, it explores the six dimensions of self-compassion: self- kindness, self-judgment, common humanity, isolation, mindfulness, and over-identified. The total score ranges from 0-60 and will be computed into a mean score (range from 1-5) for analysis. High capacity for self-compassion is reflected by a high score. Cronbach's α is 0.64 for the Chinese version.

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

Secondary Outcomes (6)

• Change of self-efficacy assessed by SEMCD

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of perceived social support

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of Constipation severity

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of Bowel habits

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

• Change of Gut microbiota composition

  A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment

Study Arms (2)

Mindful yoga intervention

EXPERIMENTAL

The intervention, comprising six 90-minute sessions, will be delivered by a trained mindful yoga instructor in group format. The intervention is based on our previously tested mindfulness yoga programme for people with PD (31). Following a universal Hatha Yoga practice, the session comprises mindfulness practice of yoga sequence, breathing exercise, and guided meditation. Both face-to-face and home-based online modes of delivery are available.

Behavioral: Mind-body interventions

Arts-based therapy intervention

EXPERIMENTAL

Participants in the six 90-minute sessions in this intervention will be engaged in art-making processes through multiple art modalities such as visual arts, dance/ movement, music, drama, and creative writing. Each section is usually structured with Filling-in - greetings and check-in, Bridging - warm-up, Decentering - arts making and appreciation, Harvesting - sharing and response, and Closure. Both face- to-face and home-based online modes of delivery are available.

Behavioral: Mind-body interventions

Interventions

Mind-body interventions BEHAVIORAL

Parallel randomized controlled trial

Arts-based therapy intervention; Mindful yoga intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who are diagnosed with idiopathic, mild-to-advance PD as indicated by Hoehn and Yahr Scale (19) Stage I to IV (those with unilateral/bilateral symptoms, with/without postural instability who are able to walk at least 3 meters or stand unassisted);
• aged 18 or above;
• able to give written informed consent;
• able to access to the internet and smartphone/ tablet/ laptop will be included; and
• able to comprehend Chinese will be included.

You may not qualify if:

• participants have significant cognitive impairment as indicated by the Abbreviated Mental Test lower than 6 significant
• participants have been regularly engaged in regular instructor-led mind-body exercise (e.g., Taichi) or arts-based therapies (\>2 times per week) in the past 3 months
• currently participating in any other behavioral or pharmacological trial
• participants have other contraindication(s) that may limit their full participation (e.g. severe hearing or vision impairment, etc.).

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Society for Rehabilitation: collaborator
• The Hong Kong Jockey Club Charities Trust: collaborator

Study Sites (1)

2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Rainbow T.H. Ho

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 11, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)