MOVIN' CARE for PD (Risk Management) (jcpdmcP)

The University of Hong Kong (HKU)

Status: Active, not recruiting

Conditions: Parkinson's Disease (At-risk Cases)

Treatments: Behavioral: Preventive interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT06147284

EA230262P

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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308 participants in 4 patient groups

Traditional exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Preventive interventions

Yoga intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Preventive interventions

Arts-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Preventive interventions

Somatic intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Preventive interventions