Parkinson Disease
Conditions
Keywords
Parkinson disease, walking, fMRI, exercise, dance, treadmill
Brief 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. 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.
Interventions
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosis of Parkinson disease 2. at least grade 3/5 strength and normal joint ranges of motion in both legs, 3. vision corrected to 20/40 or better, 4. 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
Exclusion criteria
1. medical condition for which exercise is contraindicated, 2. evidence of abnormality other than PD-related changes on brain imaging, 3. history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease, 4. history or evidence of orthopedic or muscular problem, 5. failed to pass magnetic resonance imaging screening procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Velocity at Baseline and 3 Months | 0 and 3 months | Walking velocity during forward and backward walking as determined by a computerized mat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | 0 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. |
| PDQ-39 Scores at Baseline and 3 Months | 0 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. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | 0 and 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. |
| Blood Oxygen Level Dependent Signal at Baseline to 3 Months | 0 and 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. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | 3 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. |
| PDQ-39 Scores at 3 Months and 6 Months | 3 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. |
| Walking Velocity at 3 Months and 6 Months | 3 and 6 months | Walking velocity during forward and backward walking as determined by a computerized mat. |
| Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treadmill Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill | 31 |
| Tango Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango | 39 |
| Stretching Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching | 26 |
| Total | 96 |
Baseline characteristics
| Characteristic | Treadmill | Tango | Stretching | Total |
|---|---|---|---|---|
| Age, Continuous | 68.52 years STANDARD_DEVIATION 9.54 | 66.73 years STANDARD_DEVIATION 9.52 | 66.18 years STANDARD_DEVIATION 7.3 | 67.16 years STANDARD_DEVIATION 8.94 |
| Disease Duration | 5.59 years STANDARD_DEVIATION 3.81 | 6.10 years STANDARD_DEVIATION 4.82 | 4.40 years STANDARD_DEVIATION 5.04 | 5.47 years STANDARD_DEVIATION 4.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 39 Participants | 26 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 39 Participants | 23 Participants | 91 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 12 Participants | 40 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 14 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 39 | 0 / 26 |
| other Total, other adverse events | 0 / 31 | 0 / 39 | 0 / 26 |
| serious Total, serious adverse events | 0 / 31 | 0 / 39 | 0 / 26 |
Outcome results
Primary
Walking Velocity at Baseline and 3 Months
Walking velocity during forward and backward walking as determined by a computerized mat.
Time frame: 0 and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill | Walking Velocity at Baseline and 3 Months | Baseline Forward Walking Velocity | 103.28 cm/sec | Standard Deviation 4.67 |
| Treadmill | Walking Velocity at Baseline and 3 Months | Forward Walking Velocity at 3 months | 109.57 cm/sec | Standard Deviation 4.65 |
| Treadmill | Walking Velocity at Baseline and 3 Months | Baseline Backward Walking Velocity | 63.45 cm/sec | Standard Deviation 4.22 |
| Treadmill | Walking Velocity at Baseline and 3 Months | Backward Walking Velocity at 3 months | 64.89 cm/sec | Standard Deviation 3.72 |
| Tango | Walking Velocity at Baseline and 3 Months | Backward Walking Velocity at 3 months | 71.87 cm/sec | Standard Deviation 4.83 |
| Tango | Walking Velocity at Baseline and 3 Months | Baseline Forward Walking Velocity | 104.53 cm/sec | Standard Deviation 3.92 |
| Tango | Walking Velocity at Baseline and 3 Months | Baseline Backward Walking Velocity | 60.80 cm/sec | Standard Deviation 3.7 |
| Tango | Walking Velocity at Baseline and 3 Months | Forward Walking Velocity at 3 months | 103.36 cm/sec | Standard Deviation 4.21 |
| Stretching | Walking Velocity at Baseline and 3 Months | Backward Walking Velocity at 3 months | 75.17 cm/sec | Standard Deviation 6.69 |
| Stretching | Walking Velocity at Baseline and 3 Months | Forward Walking Velocity at 3 months | 110.52 cm/sec | Standard Deviation 5.02 |
| Stretching | Walking Velocity at Baseline and 3 Months | Baseline Backward Walking Velocity | 65.17 cm/sec | Standard Deviation 4.6 |
| Stretching | Walking Velocity at Baseline and 3 Months | Baseline Forward Walking Velocity | 111.21 cm/sec | Standard Deviation 3.81 |
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.
Time frame: 0 and 3 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at Baseline in Primary Motor Cortex | .110 ratio | Standard Deviation 0.165 |
| Treadmill | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at 3 months in Primary Motor Cortex | .126 ratio | Standard Deviation 0.246 |
| Tango | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at Baseline in Primary Motor Cortex | .043 ratio | Standard Deviation 0.255 |
| Tango | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at 3 months in Primary Motor Cortex | .111 ratio | Standard Deviation 0.242 |
| Stretching | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at Baseline in Primary Motor Cortex | .095 ratio | Standard Deviation 0.307 |
| Stretching | Blood Oxygen Level Dependent Signal at Baseline to 3 Months | Bold Signal at 3 months in Primary Motor Cortex | .117 ratio | Standard Deviation 0.159 |
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.
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treadmill | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 3 months | 20 score on a scale |
| Treadmill | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 6 months | 20 score on a scale |
| Tango | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 3 months | 20 score on a scale |
| Tango | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 6 months | 19 score on a scale |
| Stretching | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 3 months | 21 score on a scale |
| Stretching | Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months | MiniBESTest at 6 months | 20 score on a scale |
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.
Time frame: 0 and 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treadmill | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBEST at baseline | 19 score on a scale |
| Treadmill | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBESTest at 3 months | 19 score on a scale |
| Tango | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBEST at baseline | 19 score on a scale |
| Tango | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBESTest at 3 months | 19 score on a scale |
| Stretching | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBEST at baseline | 20 score on a scale |
| Stretching | Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months | MiniBESTest at 3 months | 21 score on a scale |
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.
Time frame: 3 and 6 months
Population: Analysis included only participants who completed the study visit at the six month time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treadmill | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 3 months | 32 score on a scale |
| Treadmill | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 6 months | 32 score on a scale |
| Tango | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 3 months | 32 score on a scale |
| Tango | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 6 months | 35 score on a scale |
| Stretching | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 3 months | 33 score on a scale |
| Stretching | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months | MDS-UPDRS-III at 6 months | 38 score on a scale |
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.
Time frame: 0 and 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treadmill | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at baseline | 37 score on a scale |
| Treadmill | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at 3 months | 33 score on a scale |
| Tango | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at baseline | 37 score on a scale |
| Tango | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at 3 months | 33 score on a scale |
| Stretching | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at baseline | 38 score on a scale |
| Stretching | Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months | MDS-UPDRS-III at 3 months | 33 score on a scale |
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.
Time frame: 3 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 3 months | 17.86 score on a scale | Standard Deviation 2.41 |
| Treadmill | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 6 months | 12.66 score on a scale | Standard Deviation 2.41 |
| Tango | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 3 months | 18.80 score on a scale | Standard Deviation 1.85 |
| Tango | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 6 months | 19.20 score on a scale | Standard Deviation 1.75 |
| Stretching | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 3 months | 16.39 score on a scale | Standard Deviation 2.35 |
| Stretching | PDQ-39 Scores at 3 Months and 6 Months | PDQ-39 at 6 months | 9.33 score on a scale | Standard Deviation 1.4 |
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.
Time frame: 0 and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at baseline | 19.22 score on a scale | Standard Deviation 2.71 |
| Treadmill | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at 3 months | 17.86 score on a scale | Standard Deviation 2.41 |
| Tango | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at baseline | 18.33 score on a scale | Standard Deviation 1.89 |
| Tango | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at 3 months | 18.80 score on a scale | Standard Deviation 1.85 |
| Stretching | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at baseline | 16.30 score on a scale | Standard Deviation 1.86 |
| Stretching | PDQ-39 Scores at Baseline and 3 Months | PDQ-39 at 3 months | 16.39 score on a scale | Standard Deviation 2.35 |
Secondary
Walking Velocity at 3 Months and 6 Months
Walking velocity during forward and backward walking as determined by a computerized mat.
Time frame: 3 and 6 months
Population: Analysis included only those participants who completed the 6 month visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treadmill | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 3 months | 116.7 cm/sec |
| Treadmill | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 6 months | 113.9 cm/sec |
| Treadmill | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 3 months | 78.8 cm/sec |
| Treadmill | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 6 months | 74.2 cm/sec |
| Tango | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 6 months | 70.3 cm/sec |
| Tango | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 3 months | 109.7 cm/sec |
| Tango | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 3 months | 67.8 cm/sec |
| Tango | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 6 months | 108.4 cm/sec |
| Stretching | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 6 months | 68.2 cm/sec |
| Stretching | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 6 months | 117 cm/sec |
| Stretching | Walking Velocity at 3 Months and 6 Months | Backward Walking Velocity at 3 months | 73.4 cm/sec |
| Stretching | Walking Velocity at 3 Months and 6 Months | Forward Walking Velocity at 3 months | 111.6 cm/sec |