MOVIN' CARE for PD (Risk Management)

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2027-06-11

Brief Summary

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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).

Detailed Description

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Parkinson's disease (PD), the second most common neurodegenerative disease, usually results in physical deterioration, as well as a spectrum of psychosocial sequels that could bring various challenges on one's daily lives. Patients experience common motor symptoms, including tremor, rigidity, bradykinesia, and postural instability, in parallel with psychosocial stressors (i.e., non- motor symptoms NMS), such as sleep disturbance, cognitive deficits, gastrointestinal symptoms, dopaminergic drug-induced behaviors (e.g., hallucination, impulse control issues) and mood disturbance (e.g., depression, anxiety). While 21% of individuals struggling with the disease reported at least one of these psychosocial symptoms within the initial stage of the disease, they are generally at risk for increased emotional distress, cognitive declines, and elevated stress hormone (cortisol) levels.

Both motor and non-motor symptoms of Parkinson's disease could affect the quality of life of individuals and that of their caregivers. A cross-sectional study conducted by our research team has explored the symptom burden and support care needs in people with PD across East and Southern Asia (n=186), revealing significant unmet needs among Hong Kong PD patients regarding their psychosocial-spiritual concerns. In particular, they experience significant, moderate palliative care needs at the early to middle course of the illness. The extent of unmet support care needs among patients with mild to moderate PD is as great as that among patients with other chronic health conditions, such as advanced cancer, late-stage lung cancer, stage 4/5 chronic obstructive pulmonary disease and late stage chronic kidney disease. The visible and unpredictable symptoms of a distorted body (e.g., tremor and gait dysfunction) and the suppressed expressions due to having a masked face, reduced voice and slurred speech often results in difficulty seeking help and stigmatization of the disease.

Despite the tremendous influences and common occurrence of NMS, they are surprisingly under- recognized in clinical practice because of the lack of spontaneous verbal complaints by the patients, as well as the lack of systematic questioning by healthcare professionals. A qualitative exploration of the illness experience of local PD patients highlighted the importance and urgent need for holistic PD interventions that emphasizes on early identification and preventive measures of individual who are at risk for PD patients, alleviation of the effects of the psychological sequels to PD patients, as well as the reduction of stigma and promotion of community support towards PD.

The study adopts a 4-arm randomized controlled design, aiming 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 PD.

Conditions

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Parkinson's Disease (At-risk Cases)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Traditional exercise

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.

Group Type EXPERIMENTAL