Parkinson DiseasePhase 1/2NCT00029809
Chinese Exercise Modalities in Parkinson's Disease
A Phase 1/2 study testing Chinese exercise modalities in people with Parkinson Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will compare the effects of two Chinese and one Western exercise modalities on the signs and symptoms of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Chinese exercise modalities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30329
About this study
This study will compare the effects of two Chinese and one Western exercise modalities on the signs and symptoms of Parkinson's disease.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Chinese exercise modalities
- Keywords
- Parkinsons Disease, Chinese exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese exercise modalitiesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jorge L. Juncos, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029809
- Sponsor's protocol ID
- R01AT000612-01
- Status last verified
- Jul 2006
- First submitted
- 23 Jan 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Exercise Modalities in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00029809
- Acronym / sponsor ID
- R01AT000612-01
- Conditions
- Parkinson Disease
- Keywords
- Parkinsons Disease, Chinese exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- First posted
- 24 Jan 2002 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chinese exercise modalities | Behavioural | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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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.
Jorge L. Juncos, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chinese exercise modalities in people with Parkinson Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 0 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 18 Aug 2006. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029809, which also lists 2 linked publications.
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 18 Aug 2006.