Parkinson DiseasejcpdmcINCT06078046
MOVIN' CARE for PD (Mind-body Interventions)
A study testing Mind-body interventions in people with Parkinson Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mind-body interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jul 2023to 11 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research
Hong Kong
About this study
Official title: MOVIN' CARE for PD: A Project on Community Awareness, Rehabilitation and Empowerment for Parkinson's Disease (Mind-body Interventions)
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.
Read the detailed 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 2-arm randomized controlled design, aiming 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.
- Conditions
- Parkinson Disease
- Being tested
- Mind-body interventions
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body interventionsBehavioural
Parallel randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mind-body interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Self-efficacy will be measured by the Chinese version of Self-efficacy to Manage Chronic Disease Scale (SEMCD). The six-item scale measures the confidence of doing certain activities among people with chronic disease on a 10-point Likert scale. The mean score of the six items is used to reflect the level of self-efficacy, which ranges from 1 to 10. A high score indicates high self-efficacy. Cronbach's α is 0.88.
Measured: 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
Perceived social support will be measured by the adopted version of Duke-UNC Functional Social Support Questionnaire (SSS). On a five-point Likert scale, it measures the perceived supportiveness of other people (e.g., family members, friends, relatives, co-workers, etc.) from the respondent's point of view. The eight items reflect three types of social support: emotional, instrumental, and informational. The scale uses the average score of all items, thus the total mean score ranges from 1 to 5. A higher score indicates greater social support. The Chinese version has Cronbach's α of 0.91.
Measured: 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
Constipation severity will be measured by the 16-item Chinese version of the Constipation severity instrument (CSI) (Cronbach's α is 0.93-0.95). It consists of three subscales, namely the obstructive defecation, colonic inertia, and pain. The higher the score, the higher the constipation severity (total scores 0-78).
Measured: 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
Bowel habits will be measured by a self-reported 7-day bowel diary.
Measured: 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
Fresh stool samples will be collected to investigate participants' gut microbiota composition. Shotgun metagenomics sequencing of the fecal samples will be conducted using the DNBseqTM sequencing platform with a 100 bp paired-end protocol by BGI Tech Solutions (Hong Kong) Co., Ltd. The microbiota composition will be documented by the MetaPhlan3.
Measured: 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
User's satisfaction
User's satisfaction of the intervention will be measured by 11 items on a five- points Likert scale. The scale will be used to understand the participant's satisfaction and perceived effectiveness of the preventive intervention.
Measured: 3-month (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start26 Jul 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Society for Rehabilitation, The Hong Kong Jockey Club Charities Trust
- Responsible party
- Sponsor
- Investigators
- Rainbow T.H. Ho, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078046
- Sponsor's protocol ID
- EA230262I
- Acronym
- jcpdmcI
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOVIN' CARE for PD: A Project on Community Awareness, Rehabilitation and Empowerment for Parkinson's Disease (Mind-body Interventions)
- ClinicalTrials.gov ID
- NCT06078046
- Acronym / sponsor ID
- jcpdmcI / EA230262I
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Society for Rehabilitation, The Hong Kong Jockey Club Charities Trust
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 2-arm randomized controlled design, aiming 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful yoga intervention | Experimental | Behavioral: Mind-body interventionsThe 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. |
| Arts-based therapy intervention | Experimental | Behavioral: Mind-body interventionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body interventionsParallel randomized controlled trial | Behavioural | Arts-based therapy intervention, Mindful yoga intervention |
Primary outcome
Change of Perceived stress level
Time frame: 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
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.
Change of overall Quality of Life assessed by the WHOQOL-BREF
Time frame: 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
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.
Change of Quality of Life specified to Parkinson's Disease assessed by the PDQ-8
Time frame: 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
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.
Change of PD-related symptoms
Time frame: 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
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.
Change of self-compassion
Time frame: 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
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.
6 secondary outcomes
Change of self-efficacy assessed by SEMCD
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
User's satisfaction
Time frame: 3-month (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainbow T.H. Ho principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body interventions in people with Parkinson Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Perceived stress level (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.