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Chinese Exercise Modalities in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chinese exercise modalities
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinsons Disease, Chinese exercise

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ambulatory patients with Parkinson's Disease, defined as a clinical state in which at least two of these four cardinal features are present- 1) slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance. Ambulatory patients with Parkinson's Disease not exercising regularly more than 2x per week. Willing to be randomly assigned to 1 of the 3 exercise modalities: Tai Chi, Qi Gong and Aerobic exercise. NOTE THAT PARTICIPATION IN THE STUDY REQUIRES BI-WEEKLY PARTICIPATION IN A 16-WEEK SUPERVISED EXERCISE PROGRAM PLUS RELATED EVALUATIONS AT EMORY. ACCORDINGLY, RECRUITMENT IS LIMITED TO LOCAL PATIENTS.

Sites / Locations

  • Emory University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 23, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00029809
Brief Title
Chinese Exercise Modalities in Parkinson's Disease
Official Title
Chinese Exercise Modalities in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
This study will compare the effects of two Chinese and one Western exercise modalities on the signs and symptoms of Parkinson's disease.
Detailed Description
The long-term goal of this project is to study the effects of different exercise modalities on Parkinson's disease (PD). PD is a disorder whose primary disability stems from motor dysfunction including balance. Recent studies have shown that the risk of falling in the elderly can be reduced through the practice of the Chinese complementary and alternative medicine (CAM) such as T'ai Chi Chuan (TCC). This finding may be highly significant to PD. Although a recent report from Emory suggests PD patients can do well with aerobic (walk-run) exercise training (AET), it is still unclear whether the potential anti-Parkinsonian effect of such modalities is secondary to improved physical fitness (CRF), motor control or both. CAM interventions such as TCC may offer a unique opportunity to examine these fundamental questions. In PD we hypothesize that exercise training will reduce primary and secondary disability and that some of these changes represent adaptive reprogramming of central motor pathways. We will conduct a controlled double-blind, 16-week dose-response study of exercise based on caloric expenditure and thus on the cardiorespiratory fitness effects of exercise (CRF). The treatments will be Qi Gong (minimal caloric expenditure), TCC (low expenditure), and walk-cycle AET (moderate expenditure). We will examine exercise-induced change in motor control using quantitative measures of motor disability, including dynamic gait stability measures. We will also examine exercise effects on central and peripheral indices of Parkinsonian motor disability. A caloric "dose-response" effect of exercise would suggest CRF is a major determinant of the anti-Parkinsonian effects of exercise. If the Chinese modalities are as effective or superior to AET however, this would suggest that other mechanisms such as change in central motor programming may be playing a role (e.g. relaxation effects, reinforcement of central motor programs?). A better understanding of exercise-induced neural plasticity and motor control would offer a significant, and heretofore unexploited rehabilitative potential in PD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinsons Disease, Chinese exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Chinese exercise modalities

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory patients with Parkinson's Disease, defined as a clinical state in which at least two of these four cardinal features are present- 1) slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance. Ambulatory patients with Parkinson's Disease not exercising regularly more than 2x per week. Willing to be randomly assigned to 1 of the 3 exercise modalities: Tai Chi, Qi Gong and Aerobic exercise. NOTE THAT PARTICIPATION IN THE STUDY REQUIRES BI-WEEKLY PARTICIPATION IN A 16-WEEK SUPERVISED EXERCISE PROGRAM PLUS RELATED EVALUATIONS AT EMORY. ACCORDINGLY, RECRUITMENT IS LIMITED TO LOCAL PATIENTS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge L. Juncos, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

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Chinese Exercise Modalities in Parkinson's Disease

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