A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease

NCT ID: NCT05447975

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2022-01-01

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tai Chi group

Group Type: EXPERIMENTAL

Tai Chi training

Intervention Type: OTHER

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tai Chi training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of Parkinson's disease according to 2015 MDS diagnostic criteria and United Kingdom Brain Bank diagnostic criteria in 1992;

2. Hoehn - Yahr staging: 1 - 2.5;

3. 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;

Exclusion Criteria

1. Secondary causes, such as inflammatory, drug-induced, vascular and toxin-induced parkinsonism.

2. Parkinsonism with other neurodegenerative diseases, such as progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, Wilson's disease.

3. Other neurological diseases, such as stroke.

4. Patients who were receiving any other clinical trials or regular exercise protocols.

5. Patients who had fall incidents in the 6 months before recruiting due to safety considerations.

6. Patients whose Mini-Mental State Examination (MMSE) scores were less than 24.

7. Patients who had medical history that did not fit to exercise, such as orthopedics diseases or cardiopulmonary dysfunction.

8. Patients who received education less than 6 years.

9. Patients who could not walk and live independently.

10. Patients who received brain surgery (e.g. deep brain stimulation);

11. Patients whose exercise length longer than 50 minutes per week.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengdi Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37875337 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RuijinH-202205

Identifier Type: -

Identifier Source: org_study_id