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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Tai Chi training

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai Chi group

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05447975

First Posted

May 27, 2022

Last Updated

July 3, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05447975

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

July 31, 2021 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

394 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tai Chi group

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Tai Chi training

Intervention Description

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.

Primary Outcome Measure Information:

Title

the annual change of UPDRS total score measured in "ON" state at three follow-ups

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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. 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.

12. IPD Sharing Statement

Learn more about this trial

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

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