Parkinson DiseaseNCT01768832
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
A study testing Treadmill, Tango and Stretching in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Treadmill, Tango and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Parkinson disease
- at least grade 3/5 strength and normal joint ranges of motion in both legs,
- vision corrected to 20/40 or better,
- able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),
- 6) no history of vestibular disease, 7) no evidence of dementia
Who cannot join
- medical condition for which exercise is contraindicated,
- evidence of abnormality other than PD-related changes on brain imaging,
- history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,
- history or evidence of orthopedic or muscular problem,
- failed to pass magnetic resonance imaging screening procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. In particular, dance and treadmill training have been individually shown to improve walking performance and quality of life. At present it is not clear whether dance or treadmill training have similar effects or if one is superior to the other. Furthermore, our understanding of the means by which these exercise interventions convey benefits is extremely limited. This study aims to address these knowledge gaps by directly comparing dance, treadmill training and stretching (control group). The primary area of interest is the effects on gait, with secondary measures of disease severity, balance, and quality of life. The investigators will determine not only the effects of the interventions on walking performance, but will also investigate the effects of the interventions on connections between different parts of the brain and on brain function during imagined walking tasks using functional magnetic resonance imaging (fMRI). Participants will be randomly assigned to dance, treadmill training, or a stretching/flexibility control group. Participants will be assessed over a period of 6 months at 3 different time points. The investigators hypothesize that both dance and treadmill training will lead to improvements in forward walking, but that dance will result in greater improvements in backward walking compared to treadmill training. Furthermore, the investigators hypothesize that the tango and treadmill interventions will have different effects of brain function and brain connections. The investigators expect dance to enhance the activity and connections of particular brain regions and treadmill training to enhance activity and connections of different brain regions. The investigators do not expect changes in brain activity or connections in the control group.
- Conditions
- Parkinson Disease
- Being tested
- Treadmill, Tango, Stretching
- Keywords
- Parkinson disease, walking, fMRI, exercise, dance, treadmill
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillBehavioural
TangoBehavioural
StretchingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treadmill | Experimental | Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. Receives: Behavioral: Treadmill |
| Tango | Experimental | Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. Receives: Behavioral: Tango |
| Stretching | Active comparator | Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Velocity at Baseline and 3 Months
Walking velocity during forward and backward walking as determined by a computerized mat.
Measured: 0 and 3 months
Secondary outcomes (8)
Blood Oxygen Level Dependent Signal at Baseline to 3 Months
Measure of the ratio of oxygenated to deoxygenated blood in areas of the brain at a specific time. Used as an indirect assessment of brain activity and connections. Higher values indicate more brain activity in the brain areas of interest.
Measured: 0 and 3 months
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.
Measured: 0 and 3 months
PDQ-39 Scores at Baseline and 3 Months
The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.
Measured: 0 and 3 months
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months
The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.
Measured: 0 and 3 months
Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.
Measured: 3 and 6 months
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months
The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.
Measured: 3 and 6 months
PDQ-39 Scores at 3 Months and 6 Months
The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.
Measured: 3 and 6 months
Walking Velocity at 3 Months and 6 Months
Walking velocity during forward and backward walking as determined by a computerized mat.
Measured: 3 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 posted15 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gammon M Earhart, PhD, PT, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768832
- Sponsor's protocol ID
- 1R01NS077959-01A1
- Status last verified
- Nov 2018
- First submitted
- 8 Jan 2013
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rawson KS, McNeely ME, Duncan RP, Pickett KA, Perlmutter JS, Earhart GM. Exercise and Parkinson Disease: Comparing Tango, Treadmill, and Stretching. J Neurol Phys Ther. 2019 Jan;43(1):26-32. doi: 10.1097/NPT.0000000000000245.
PubMed 30531383Earhart GM, Duncan RP, Huang JL, Perlmutter JS, Pickett KA. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial. BMC Neurol. 2015 Feb 5;15:9. doi: 10.1186/s12883-015-0261-0.
PubMed 25652002
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
- ClinicalTrials.gov ID
- NCT01768832
- Acronym / sponsor ID
- 1R01NS077959-01A1
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, walking, fMRI, exercise, dance, treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. In particular, dance and treadmill training have been individually shown to improve walking performance and quality of life. At present it is not clear whether dance or treadmill training have similar effects or if one is superior to the other. Furthermore, our understanding of the means by which these exercise interventions convey benefits is extremely limited. This study aims to address these knowledge gaps by directly comparing dance, treadmill training and stretching (control group). The primary area of interest is the effects on gait, with secondary measures of disease severity, balance, and quality of life. The investigators will determine not only the effects of the interventions on walking performance, but will also investigate the effects of the interventions on connections between different parts of the brain and on brain function during imagined walking tasks using functional magnetic resonance imaging (fMRI). Participants will be randomly assigned to dance, treadmill training, or a stretching/flexibility control group. Participants will be assessed over a period of 6 months at 3 different time points. The investigators hypothesize that both dance and treadmill training will lead to improvements in forward walking, but that dance will result in greater improvements in backward walking compared to treadmill training. Furthermore, the investigators hypothesize that the tango and treadmill interventions will have different effects of brain function and brain connections. The investigators expect dance to enhance the activity and connections of particular brain regions and treadmill training to enhance activity and connections of different brain regions. The investigators do not expect changes in brain activity or connections in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treadmill | Experimental | Behavioral: TreadmillIndividuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. |
| Tango | Experimental | Behavioral: TangoIndividuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. |
| Stretching | Active comparator | Behavioral: StretchingIndividuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of Parkinson disease
- at least grade 3/5 strength and normal joint ranges of motion in both legs,
- vision corrected to 20/40 or better,
- able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),
- 6) no history of vestibular disease, 7) no evidence of dementia
Key exclusion criteria (5 listed)
- medical condition for which exercise is contraindicated,
- evidence of abnormality other than PD-related changes on brain imaging,
- history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,
- history or evidence of orthopedic or muscular problem,
- failed to pass magnetic resonance imaging screening procedure
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 |
|---|---|---|
| Treadmill | Behavioural | Treadmill |
| Tango | Behavioural | Tango |
| Stretching | Behavioural | Stretching |
Primary outcome
Walking Velocity at Baseline and 3 Months
Time frame: 0 and 3 months
Walking velocity during forward and backward walking as determined by a computerized mat.
8 secondary outcomes
Blood Oxygen Level Dependent Signal at Baseline to 3 Months
Time frame: 0 and 3 months
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
Time frame: 0 and 3 months
PDQ-39 Scores at Baseline and 3 Months
Time frame: 0 and 3 months
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months
Time frame: 0 and 3 months
Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
Time frame: 3 and 6 months
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months
Time frame: 3 and 6 months
PDQ-39 Scores at 3 Months and 6 Months
Time frame: 3 and 6 months
Walking Velocity at 3 Months and 6 Months
Time frame: 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30531383Rawson KS, McNeely ME, Duncan RP, Pickett KA, Perlmutter JS, Earhart GM. Exercise and Parkinson Disease: Comparing Tango, Treadmill, and Stretching. J Neurol Phys Ther. 2019 Jan;43(1):26-32. doi: 10.1097/NPT.0000000000000245.
- Derived from this study: PubMed 25652002Earhart GM, Duncan RP, Huang JL, Perlmutter JS, Pickett KA. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial. BMC Neurol. 2015 Feb 5;15:9. doi: 10.1186/s12883-015-0261-0.
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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.
Gammon M Earhart, PhD, PT principal investigator
Washington University School 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 Treadmill, Tango and Stretching in people with Parkinson Disease, run by Washington University School 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 5 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 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Walking Velocity at Baseline and 3 Months (time frame: 0 and 3 months). 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 NCT01768832, 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 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.