MOVIN' CARE for PD (Risk Management)

NCT06147284 | Active Not Recruiting

• 1 other identifier: EA230262P
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention study is to investigate the effectiveness of three preventive interventions - yoga, arts-based approaches, and somatic practices, with reference to an active control group - traditional exercises, in enhancing psycho-social-spiritual well-being among people at risk of Parkinson's disease (Parkivers). The hypotheses include: H1: Yoga, arts-based, somatic interventions will significantly improve the psycho-social- spiritual wellbeing (i.e., perceived stress, anxiety and depressive symptoms, and quality of life) among Parkivers H2: In comparison to traditional exercise, yoga, arts-based, and somatic interventions will have a significant effect on psycho-social-spiritual well-being among Parkivers H3: Yoga, arts-based, somatic, and traditional exercise training interventions will have a significant effect in reducing PD-related motor symptoms H4: Yoga, arts-based, somatic interventions have a significant long-term effect on improving psycho-social-spiritual well-being among Parkivers Eligible participants will be invited to undergo baseline assessments before randomization to attend a six-session intervention group. To investigate the immediate and long-term effect of the preventive measures, repeated outcome measures will be conducted at six time-points: A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

Conditions

Parkinson's Disease (At-risk Cases)

Outcome Measures

Primary Outcomes (2)

• 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. 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 baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

• Change of Quality of Life

  The brief World Health Organization Quality-of-Life Scale (WHOQOL-BREF) 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 baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

Secondary Outcomes (6)

• Change of PD-related motor and non-motor symptoms

  A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

• Change of Anxiety and depressive symptoms

  A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

• Change of Constipation severity

  A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

• Change of Bowel habits

  A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

• Change of Gut microbiota composition

  A baseline assessment prior to randomization (T0), and follow-ups at 2-months (T1), 6-months (T2), 12-months (T3), 18- months (T4), 24-months (T5).

Study Arms (4)

Traditional exercise

EXPERIMENTAL

This is an intervention with six 90-minute sessions. Progressive traditional exercise including warm-up exercises, resistance training, stretching routines, and cool-down exercises will be introduced. Both face-to-face and home-based online modes of delivery are available.

Behavioral: Preventive interventions

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: Preventive interventions

Arts-based 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: Preventive interventions

Somatic intervention

EXPERIMENTAL

The intervention involves six 90-minute sessions led by a trained somatic practitioner in group format. Participants will be guided to bring awareness to their body and to connect with their internal sensations through exploring imageries related to their somatic experiences. They will also learn some somatic techniques that enable them to use their bodies more effectively. Both face-to-face and home- based online modes of delivery are available.

Behavioral: Preventive interventions

Interventions

Preventive interventions BEHAVIORAL

Parallel randomized controlled trial

Arts-based intervention; Somatic intervention; Traditional exercise; 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 aged 18 or above
• able to give written informed consent
• able to have access to the Internet and a smartphone/tablet/laptop
• willing to download mobile apps related to the research project
• able to comprehend Chinese.

You may not qualify if:

• significantly cognitive impaired (indicated by Abbreviated Mental Test lower than 6)
• engaged in regular instructor-led mind-body exercise (e.g., Taichi), expressive arts therapy, or somatic practices (\>2 times per week) in the past 3 months)
• currently participating in any other behavioral or pharmacological trial
• with other contradiction(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

Condition Hierarchy (Ancestors)

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

Study Officials

• Rainbow T.H. Ho, PhD

  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. All outcome assessors will be blinded to subject allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: December 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)