Parkinson DiseaseNCT02418780
Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
A study testing Tai Chi in people with Parkinson Disease, run by Harvard University Faculty of Medicine at 1 site in United States.
Trial summary
The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals recently diagnosed with idiopathic PD (≤ 10 years)
- Limited disease progression
- If taking PD-related medication, willingness to undergo baseline and follow-up testing while off medication
- Willingness to commit to the study protocols and complete Tai Chi program
- Willingness to be videotaped and audio-recorded during testing
Who cannot join
- Diagnosis of any form of atypical parkinsonism
- History of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism
- Any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating Rheumatoid Arthritis, history of frequent falls, unhealed fracture)**
- Unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our Tai Chi exercise program
- Participation in brain stimulation within the past 3 months
- Family history of seizures or unexplained loss of consciousness
Show all 12Show fewer
- Current history of dementia or severe psychiatric illness. Patients with mild (non-suicidal) depression and/or anxiety may be included
- Acute illness requiring hospitalization within past 3 months
- History of deep brain stimulation or other brain surgery
- Participation in brain stimulation within the past 3 months
- Regular use of walking aid
- Significant Tai Chi experience (> 6 months training in past 2 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD).
Read the detailed description
Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD into a 6-month randomized controlled trial of Tai Chi exercise.
Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with PD.
- Conditions
- Parkinson Disease
- Being tested
- Tai Chi
- 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 ChiOther
6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 6-month Tai Chi training program combined with usual medical care Receives: Other: Tai Chi |
| Usual Care | No intervention | Waitlist control group receiving usual medical care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participant recruitment
Measured: 24 months
Protocol adherence
The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
Measured: 6 months
Retention
The percentage of study visits completed by each participant.
Measured: 6 months
Secondary outcomes (11)
Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Motor symptom severity
Measured: Baseline and 6 months
Change from Baseline in PDQ-39
PD-related quality of life
Measured: Baseline and 6 months
Change from Baseline in Physical Activity Status Scale (PASS)
Measured: Baseline and 6 months
Change from Baseline in Self-Efficacy for Exercise Scale
Measured: Baseline and 6 months
Change from Baseline in Activity-specific Balance Confidence Scale
Measured: Baseline and 6 months
Change from Baseline in Profile of Mood State
Measured: Baseline and 6 months
Change from Baseline in Single leg stance time
Measured: Baseline and 6 months
Change from Baseline in Timed Up and Go Test
Measured: Baseline and 6 months
Change from Baseline in Steady state gait dynamics
Steady state gait dynamics during 90 seconds of continuous over ground walking at preferred speed with and without use of dual task challenges
Measured: Baseline and 6 months
Change from Baseline in Balance/Postural control
Sway based measures of balance during quiet and tandem standing, with and without dual tasks
Measured: Baseline and 6 months
Change from Baseline in Cognitive function
Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Peter Wayne, Harvard University Faculty of Medicine
- Investigators
- Peter M Wayne, PhD, Principal investigator, Harvard University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418780
- Sponsor's protocol ID
- 2013P002343
- Status last verified
- Aug 2016
- First submitted
- 6 Apr 2015
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02418780
- Acronym / sponsor ID
- 2013P002343
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- Spaulding Rehabilitation Hospital, Beth Israel Deaconess Medical Center
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Apr 2015 (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.
The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD).
Detailed description
Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD into a 6-month randomized controlled trial of Tai Chi exercise.
Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with PD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Other: Tai Chi6-month Tai Chi training program combined with usual medical care |
| Usual Care | No intervention | –Waitlist control group receiving usual medical care alone |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals recently diagnosed with idiopathic PD (≤ 10 years)
- Limited disease progression
- If taking PD-related medication, willingness to undergo baseline and follow-up testing while off medication
- Willingness to commit to the study protocols and complete Tai Chi program
- Willingness to be videotaped and audio-recorded during testing
Key exclusion criteria (12 listed)
- Diagnosis of any form of atypical parkinsonism
- History of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism
- Any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating Rheumatoid Arthritis, history of frequent falls, unhealed fracture)**
- Unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our Tai Chi exercise program
- Participation in brain stimulation within the past 3 months
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 Chi6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice | Other | Tai Chi |
Primary outcome
Rate of participant recruitment
Time frame: 24 months
Protocol adherence
Time frame: 6 months
The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
Retention
Time frame: 6 months
The percentage of study visits completed by each participant.
11 secondary outcomes
Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Baseline and 6 months
Change from Baseline in PDQ-39
Time frame: Baseline and 6 months
Change from Baseline in Physical Activity Status Scale (PASS)
Time frame: Baseline and 6 months
Change from Baseline in Self-Efficacy for Exercise Scale
Time frame: Baseline and 6 months
Change from Baseline in Activity-specific Balance Confidence Scale
Time frame: Baseline and 6 months
Change from Baseline in Profile of Mood State
Time frame: Baseline and 6 months
Change from Baseline in Single leg stance time
Time frame: Baseline and 6 months
Change from Baseline in Timed Up and Go Test
Time frame: Baseline and 6 months
Change from Baseline in Steady state gait dynamics
Time frame: Baseline and 6 months
Change from Baseline in Balance/Postural control
Time frame: Baseline and 6 months
Change from Baseline in Cognitive function
Time frame: Baseline and 6 months
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 19 Aug 2016.
- 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.
Related trials for Parkinson Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
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.
Peter M Wayne, PhD principal investigator
Harvard University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Parkinson Disease, run by Harvard University Faculty of Medicine 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 5 inclusion and 12 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 19 Aug 2016. 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.
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?
Rate of participant recruitment (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT02418780, 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 19 Aug 2016.