Parkinson DiseaseNCT05447975
A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease
A study testing Tai Chi training in people with Parkinson Disease, run by Ruijin Hospital.
Trial summary
The investigators proposed to conduct a cohort study to observe whether Tai Chi intervention could delay the disease progression of Parkinson's disease (PD). PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from Jan. 2016 to Jan. 2019. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Tai Chi training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease according to 2015 MDS diagnostic criteria and United Kingdom Brain Bank diagnostic criteria in 1992;
- Hoehn - Yahr staging: 1 - 2.5;
- The medication was stable at least 3 months before recruiting and not changed during follow-up unless increasing antiparkinsonian drugs or the need of deep brain stimulation (DBS) is required according to the disease severity;
Who cannot join
- Secondary causes, such as inflammatory, drug-induced, vascular and toxin-induced parkinsonism.
- Parkinsonism with other neurodegenerative diseases, such as progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, Wilson's disease.
- Other neurological diseases, such as stroke.
- Patients who were receiving any other clinical trials or regular exercise protocols.
- Patients who had fall incidents in the 6 months before recruiting due to safety considerations.
- Patients whose Mini-Mental State Examination (MMSE) scores were less than 24.
Show all 11Show fewer
- Patients who had medical history that did not fit to exercise, such as orthopedics diseases or cardiopulmonary dysfunction.
- Patients who received education less than 6 years.
- Patients who could not walk and live independently.
- Patients who received brain surgery (e.g. deep brain stimulation);
- Patients whose exercise length longer than 50 minutes per week.
About this study
The investigators proposed to conduct a cohort study to observe whether Tai Chi intervention could delay the disease progression of Parkinson's disease (PD).
PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from Jan. 2016 to Jan. 2019. Each participant was assessed before participants joined the Tai Chi class. After the recruitment, participants accepted continuous Tai Chi training in the classes till the last follow-up. The investigators performed three times of follow-up in Nov. - Dec. 2019, Oct. - Nov. 2020 and Jun. - July 2021. Using propensity score matching, the investigators matched PD patients who did not receive Tai Chi training as control group in gender, disease duration, age, and Hoehn - Yahr staging. The aim is to observe the effect of Tai Chi on delaying the disease progression of PD.
- Conditions
- Parkinson Disease
- Being tested
- Tai Chi training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi trainingOther
As for Tai Chi training, standardized Tai Chi was taught by professional Tai Chi coaches from Sino Taiji of Fuxing International in classes: Qishi ("Starting Posture"), Shangsanbu ("Twist Step"), Yema Fenzong("Part the Wild Horse's Mane on Both Side"), Jingang Daozhui ("Buddha's warrior attendant pounds mortar"), Shoushi ("Closing Posture"). Patients participated in this class were trained, twice a week, 60 min per time. PD patients whose attendance rate less than 75% were excluded.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | Not described Receives: Other: Tai Chi training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the annual change of UPDRS total score measured in "ON" state at three follow-ups
the annual change of Unified Parkinson's Disease Rating Scale (UPDRS) total score measured in "ON" state at three follow-ups. The range of UPDRS is between 0 and 207. The higher score means a worse outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jan 2016
- Primary completion31 Jul 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447975
- Sponsor's protocol ID
- RuijinH-202205
- Status last verified
- Jul 2022
- First submitted
- 27 May 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li G, Huang P, Cui S, He Y, Tan Y, Chen S. Effect of long-term Tai Chi training on Parkinson's disease: a 3.5-year follow-up cohort study. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):222-228. doi: 10.1136/jnnp-2022-330967.
PubMed 37875337
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05447975
- Acronym / sponsor ID
- RuijinH-202205
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 Jul 2022 (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 investigators proposed to conduct a cohort study to observe whether Tai Chi intervention could delay the disease progression of Parkinson's disease (PD).
PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from Jan. 2016 to Jan. 2019. Each participant was assessed before participants joined the Tai Chi class. After the recruitment, participants accepted continuous Tai Chi training in the classes till the last follow-up. The investigators performed three times of follow-up in Nov. - Dec. 2019, Oct. - Nov. 2020 and Jun. - July 2021. Using propensity score matching, the investigators matched PD patients who did not receive Tai Chi training as control group in gender, disease duration, age, and Hoehn - Yahr staging. The aim is to observe the effect of Tai Chi on delaying the disease progression of PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Other: Tai Chi training |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Parkinson's disease according to 2015 MDS diagnostic criteria and United Kingdom Brain Bank diagnostic criteria in 1992;
- Hoehn - Yahr staging: 1 - 2.5;
- The medication was stable at least 3 months before recruiting and not changed during follow-up unless increasing antiparkinsonian drugs or the need of deep brain stimulation (DBS) is required according to the disease severity;
Key exclusion criteria (11 listed)
- Secondary causes, such as inflammatory, drug-induced, vascular and toxin-induced parkinsonism.
- Parkinsonism with other neurodegenerative diseases, such as progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, Wilson's disease.
- Other neurological diseases, such as stroke.
- Patients who were receiving any other clinical trials or regular exercise protocols.
- Patients who had fall incidents in the 6 months before recruiting due to safety considerations.
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 |
|---|---|---|
| Tai Chi trainingAs for Tai Chi training, standardized Tai Chi was taught by professional Tai Chi coaches from Sino Taiji of Fuxing International in classes: Qishi ("Starting Posture"), Shangsanbu ("Twist Step"), Yema Fenzong("Part the Wild Horse's Mane on Both Side"), Jingang Daozhui ("Buddha's warrior attendant pounds mortar"), Shoushi ("Closing Posture"). Patients participated in this class were trained, twice a week, 60 min per time. PD patients whose attendance rate less than 75% were excluded. | Other | Tai Chi group |
Primary outcome
the annual change of UPDRS total score measured in "ON" state at three follow-ups
Time frame: 1 year
the annual change of Unified Parkinson's Disease Rating Scale (UPDRS) total score measured in "ON" state at three follow-ups. The range of UPDRS is between 0 and 207. The higher score means a worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 37875337Li G, Huang P, Cui S, He Y, Tan Y, Chen S. Effect of long-term Tai Chi training on Parkinson's disease: a 3.5-year follow-up cohort study. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):222-228. doi: 10.1136/jnnp-2022-330967.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi training in people with Parkinson Disease, run by Ruijin Hospital.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the annual change of UPDRS total score measured in "ON" state at three follow-ups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447975, which also lists 1 linked publication.
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 7 Jul 2022.