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Parkinson DiseaseNCT03563807

Golf Instruction Versus Tai Chi for People With Parkinson's Disease

A study testing Golf Instruction and Tai Chi Class in people with Parkinson Disease and Movement Disorders, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the feasibility and tolerability of golf instruction for participants with moderate to advanced Parkinson's disease (PD). Other forms of exercise have been shown to be beneficial for PD. Golf is a low impact sport that utilizes balance and strength. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Golf Instruction and Tai Chi Class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
23 Apr 2018to 1 Jun 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants with a diagnosis of Parkinson's disease by a Movement Disorders specialist, H\&Y stage II-III in the "On" state treated with Parkinson's disease medications
  • Participants must be capable of providing informed consent and complying with trial procedures including transportation to and from classes.
  • Participants must be willing and able to participate in group exercise classes.
  • Participants who are engaged in physical therapy or other exercise programs must be at a stable regimen for 60 days prior to the start of the study and must be willing to maintain their current regimen for the duration of the study.

Who cannot join

  • Clinical evidence of unstable medical or psychiatric illness which would prevent them from engaging in exercise
  • Participants who are already active golfers or currently active in Tai Chi would be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Feasibility and Tolerability of Group Golf Instruction Versus Tai Chi for Patients With Moderate to Advanced Parkinson's Disease

The purpose of this study is to determine the feasibility and tolerability of golf instruction for participants with moderate to advanced Parkinson's disease (PD). Other forms of exercise have been shown to be beneficial for PD. Golf is a low impact sport that utilizes balance and strength. Currently, there are no data looking at the effects of golf on PD. This pilot study aims to test the effects of golf in the PD patient population, particularly its effect on balance. In this study, we will be comparing group golf instruction to group Tai Chi lessons (the gold standard balance exercise for patients with PD).

Read the detailed description

Approximately, 40-50 participants with Parkinson's Disease (H\&Y stage 2 to 3) will be enrolled in this study. Participants who provide informed consent will be randomized 1:1 to either group golf instruction or group Tai Chi classes. Participants will be evaluated before and after the intervention with a battery of cognitive, motor and balance assessments including the UPDRS, the Mini-BESTest of balance, and timed up and go tests. They will participate in classes twice weekly for 10 weeks which will be provided free of charge. At the end of the intervention period they will repeat the assessments. The primary outcomes of the study are feasibility and tolerability. The key secondary objectives are to measure the efficacy of golf instruction on measures of balance, risk of falls.

Being tested
Golf Instruction, Tai Chi Class
Medical subject headings
Parkinson Disease, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Golf InstructionOther

    Subjects will participate in two weekly hour-long golf classes. Classes will be led by professional golf instructors that will work with individuals to teach participants how to play golf. This will include stretching, individual coaching, and working with participants to maximize their golf swing.

  • Tai Chi ClassOther

    Tai Chi is an ancient martial art that uses meditative movement to improve strength, flexibility, and balance. Subjects will participate in two weekly hour-long Tai Chi classes.The class will be led by a certified Tai Chi instructor and consist of approximately 12 people.

Study groups in NCT03563807
Study groupRoleWhat they receive
GolfExperimentalGroup golf lessons will be led by professional golf instructors.
Receives: Other: Golf Instruction
Tai ChiActive comparatorGroup Tai Chi classes led by a certified Tai Chi instructor.
Receives: Other: Tai Chi Class

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability of group golf instruction compared to Tai Chi

    The number of participants who complete 10 weeks in the study will be measured using weekly attendance sheets. We will consider the intervention to be tolerable if the proportion of participants who withdraw consent prior to the end of the study is less than 40% with 80% confidence.

    Measured: Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.

Secondary outcomes (3)

  1. Safety of group golf instruction compared to Tai Chi

    The frequency of treatment-related adverse events including falls will be summarized by treatment group and system organ class by CTCAE v 4.0

    Measured: Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.

  2. Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.

    The Mini-BESTest will be used to measure balance before and after the intervention. The Mini-BESTest is scored from 0-28 where lower scores are better.

    Measured: Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.

  3. Activities Specific Balance Confidence Scale

    This is a self-reported measure of confidence in performing various ambulatory activities without falling. The scale is out of 100

    Measured: Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start23 Apr 2018
  3. Primary completion30 Mar 2020
  4. Study completion1 Jun 2020

Resources

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563807
Sponsor's protocol ID
2018P000394
Status last verified
Sep 2020
First submitted
8 May 2018
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.

    PubMed 29027544

  • Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.

    PubMed 22316445

  • Gao KL, Hui-Chan CW, Tsang WW. Golfers have better balance control and confidence than healthy controls. Eur J Appl Physiol. 2011 Nov;111(11):2805-12. doi: 10.1007/s00421-011-1910-7. Epub 2011 Mar 17.

    PubMed 21416145

  • 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 38588457

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Golf Instruction and Tai Chi Class in people with Parkinson Disease and Movement Disorders, run by Massachusetts General Hospital 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 4 inclusion and 2 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 3 Sep 2020. 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?

Tolerability of group golf instruction compared to Tai Chi (time frame: Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.). 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 NCT03563807, which also lists 5 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 3 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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