Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147284
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-19
Brief Title:
MOVIN CARE for PD Risk Management
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
MOVIN CARE for PD A Project on Community Awareness Rehabilitation and Empowerment for Parkinsons Disease Risk Management
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
jcpdmcP
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 Parkinsons disease Parkivers The hypotheses include
H1 Yoga arts-based somatic interventions will significantly improve the psycho-social- spiritual wellbeing ie 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
H1 Yoga arts-based somatic interventions will significantly improve the psycho-social- spiritual wellbeing ie 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:
Parkinsons 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 ones daily lives Patients experience common motor symptoms including tremor rigidity bradykinesia and postural instability in parallel with psychosocial stressors ie non- motor symptoms NMS such as sleep disturbance cognitive deficits gastrointestinal symptoms dopaminergic drug-induced behaviors eg hallucination impulse control issues and mood disturbance eg 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 Parkinsons 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 n186 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 45 chronic obstructive pulmonary disease and late stage chronic kidney disease The visible and unpredictable symptoms of a distorted body eg 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
Both motor and non-motor symptoms of Parkinsons 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 n186 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 45 chronic obstructive pulmonary disease and late stage chronic kidney disease The visible and unpredictable symptoms of a distorted body eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None