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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill | Experimental | Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. |
|
| Tango | Experimental | Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. |
|
| Stretching | Active Comparator | Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill | Behavioral |
| ||
| Tango |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Velocity at Baseline and 3 Months | Walking velocity during forward and backward walking as determined by a computerized mat. | 0 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 3 months |
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Inclusion Criteria:
6) no history of vestibular disease, 7) no evidence of dementia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gammon M Earhart, PhD, PT | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30531383 | Derived | 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. | |
| 25652002 | Derived | Earhart 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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| ID | Title | Description |
|---|---|---|
| FG000 | Treadmill | Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. Treadmill |
| FG001 | Tango | Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. Tango |
| FG002 | Stretching | Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. Stretching |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We analyzed baseline data only from those participants who completed at least the first 3 months of the 6 months study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treadmill | Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. Treadmill |
| BG001 | Tango | Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. Tango |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Velocity at Baseline and 3 Months | Walking velocity during forward and backward walking as determined by a computerized mat. | Posted | Mean | Standard Deviation | cm/sec | 0 and 3 months |
|
Through study completion, an average of 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treadmill | Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks. Treadmill |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gammon M. Earhart | Washington University in St. Louis | 314-286-1407 | earhartg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2017 | Sep 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D051784 | Aryl Hydrocarbon Receptor Nuclear Translocator |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Stretching | Behavioral |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 3 and 6 months |
| BG002 | Stretching | Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. Stretching |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Disease Duration | Years since being diagnosed with Parkinson's disease | Mean | Standard Deviation | years |
|
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. Stretching |
|
|
| Secondary | 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. | Due to issues with data quality related to head movement while in the MRI scanner, we had a limited numbers of participants in each group with usable MRI data. | Posted | Mean | Standard Deviation | ratio | 0 and 3 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 0 and 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 0 and 3 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 0 and 3 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 and 6 months |
|
|
|
| Secondary | 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. | Analysis included only participants who completed the study visit at the six month time point. | Posted | Median | Inter-Quartile Range | score on a scale | 3 and 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
| Secondary | Walking Velocity at 3 Months and 6 Months | Walking velocity during forward and backward walking as determined by a computerized mat. | Analysis included only those participants who completed the 6 month visit. | Posted | Median | Inter-Quartile Range | cm/sec | 3 and 6 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Tango | Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks. Tango | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | Stretching | Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks. Stretching | 0 | 26 | 0 | 26 | 0 | 26 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D029543 | Nucleocytoplasmic Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D051793 | Hypoxia-Inducible Factor 1 |
| D051792 | Basic Helix-Loop-Helix Transcription Factors |
| D004268 | DNA-Binding Proteins |
| D008565 | Membrane Proteins |
| D014157 | Transcription Factors |
|
|
|
|
|
|
|
| Forward Walking Velocity at 6 months |
|
| Backward Walking Velocity at 3 months |
|
| Backward Walking Velocity at 6 months |
|