Trial Outcomes & Findings for Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms (NCT NCT01768832)
NCT ID: NCT01768832
Last Updated: 2018-11-19
Results Overview
Walking velocity during forward and backward walking as determined by a computerized mat.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
0 and 3 months
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Treadmill
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
35
|
|
Overall Study
COMPLETED
|
31
|
39
|
26
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Baseline characteristics by cohort
| Measure |
Treadmill
n=31 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=39 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=26 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.52 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
66.73 years
STANDARD_DEVIATION 9.52 • n=7 Participants
|
66.18 years
STANDARD_DEVIATION 7.30 • n=5 Participants
|
67.16 years
STANDARD_DEVIATION 8.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Disease Duration
|
5.59 years
STANDARD_DEVIATION 3.81 • n=5 Participants
|
6.10 years
STANDARD_DEVIATION 4.82 • n=7 Participants
|
4.40 years
STANDARD_DEVIATION 5.04 • n=5 Participants
|
5.47 years
STANDARD_DEVIATION 4.59 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0 and 3 monthsWalking velocity during forward and backward walking as determined by a computerized mat.
Outcome measures
| Measure |
Treadmill
n=31 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=39 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=26 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Walking Velocity at Baseline and 3 Months
Baseline Forward Walking Velocity
|
103.28 cm/sec
Standard Deviation 4.67
|
104.53 cm/sec
Standard Deviation 3.92
|
111.21 cm/sec
Standard Deviation 3.81
|
|
Walking Velocity at Baseline and 3 Months
Forward Walking Velocity at 3 months
|
109.57 cm/sec
Standard Deviation 4.65
|
103.36 cm/sec
Standard Deviation 4.21
|
110.52 cm/sec
Standard Deviation 5.02
|
|
Walking Velocity at Baseline and 3 Months
Baseline Backward Walking Velocity
|
63.45 cm/sec
Standard Deviation 4.22
|
60.80 cm/sec
Standard Deviation 3.70
|
65.17 cm/sec
Standard Deviation 4.60
|
|
Walking Velocity at Baseline and 3 Months
Backward Walking Velocity at 3 months
|
64.89 cm/sec
Standard Deviation 3.72
|
71.87 cm/sec
Standard Deviation 4.83
|
75.17 cm/sec
Standard Deviation 6.69
|
SECONDARY outcome
Timeframe: 0 and 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treadmill
n=11 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=13 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=13 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Blood Oxygen Level Dependent Signal at Baseline to 3 Months
Bold Signal at 3 months in Primary Motor Cortex
|
.126 ratio
Standard Deviation .246
|
.111 ratio
Standard Deviation .242
|
.117 ratio
Standard Deviation .159
|
|
Blood Oxygen Level Dependent Signal at Baseline to 3 Months
Bold Signal at Baseline in Primary Motor Cortex
|
.110 ratio
Standard Deviation .165
|
.043 ratio
Standard Deviation .255
|
.095 ratio
Standard Deviation .307
|
SECONDARY outcome
Timeframe: 0 and 3 monthsThe 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.
Outcome measures
| Measure |
Treadmill
n=31 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=39 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=26 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
MiniBEST at baseline
|
19 score on a scale
Interval 15.5 to 21.5
|
19 score on a scale
Interval 17.0 to 21.0
|
20 score on a scale
Interval 18.0 to 22.0
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
MiniBESTest at 3 months
|
19 score on a scale
Interval 17.0 to 23.0
|
19 score on a scale
Interval 17.0 to 22.5
|
21 score on a scale
Interval 18.25 to 22.75
|
SECONDARY outcome
Timeframe: 0 and 3 monthsThe 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.
Outcome measures
| Measure |
Treadmill
n=31 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=39 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=26 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
PDQ-39 Scores at Baseline and 3 Months
PDQ-39 at baseline
|
19.22 score on a scale
Standard Deviation 2.71
|
18.33 score on a scale
Standard Deviation 1.89
|
16.30 score on a scale
Standard Deviation 1.86
|
|
PDQ-39 Scores at Baseline and 3 Months
PDQ-39 at 3 months
|
17.86 score on a scale
Standard Deviation 2.41
|
18.80 score on a scale
Standard Deviation 1.85
|
16.39 score on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: 0 and 3 monthsThe 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.
Outcome measures
| Measure |
Treadmill
n=31 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=39 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=26 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
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
Interval 25.0 to 39.0
|
33 score on a scale
Interval 27.5 to 41.5
|
33 score on a scale
Interval 27.25 to 38.0
|
|
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
Interval 30.0 to 41.5
|
37 score on a scale
Interval 29.5 to 41.5
|
38 score on a scale
Interval 33.25 to 44.5
|
SECONDARY outcome
Timeframe: 3 and 6 monthsThe 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.
Outcome measures
| Measure |
Treadmill
n=29 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=36 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=23 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
MiniBESTest at 3 months
|
20 score on a scale
Interval 17.0 to 23.0
|
20 score on a scale
Interval 17.0 to 23.0
|
21 score on a scale
Interval 18.5 to 23.0
|
|
Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
MiniBESTest at 6 months
|
20 score on a scale
Interval 17.0 to 22.0
|
19 score on a scale
Interval 18.0 to 22.0
|
20 score on a scale
Interval 18.0 to 21.0
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Analysis included only participants who completed the study visit at the six month time point.
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.
Outcome measures
| Measure |
Treadmill
n=29 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=36 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=23 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
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
Interval 24.0 to 38.0
|
32 score on a scale
Interval 27.0 to 39.25
|
33 score on a scale
Interval 27.0 to 38.5
|
|
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
Interval 27.0 to 40.0
|
35 score on a scale
Interval 28.75 to 41.25
|
38 score on a scale
Interval 28.5 to 44.0
|
SECONDARY outcome
Timeframe: 3 and 6 monthsThe 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.
Outcome measures
| Measure |
Treadmill
n=29 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=36 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=23 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
PDQ-39 Scores at 3 Months and 6 Months
PDQ-39 at 3 months
|
17.86 score on a scale
Standard Deviation 2.41
|
18.80 score on a scale
Standard Deviation 1.85
|
16.39 score on a scale
Standard Deviation 2.35
|
|
PDQ-39 Scores at 3 Months and 6 Months
PDQ-39 at 6 months
|
12.66 score on a scale
Standard Deviation 2.41
|
19.20 score on a scale
Standard Deviation 1.75
|
9.33 score on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Analysis included only those participants who completed the 6 month visit.
Walking velocity during forward and backward walking as determined by a computerized mat.
Outcome measures
| Measure |
Treadmill
n=29 Participants
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Treadmill
|
Tango
n=36 Participants
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Tango
|
Stretching
n=23 Participants
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Stretching
|
|---|---|---|---|
|
Walking Velocity at 3 Months and 6 Months
Forward Walking Velocity at 3 months
|
116.7 cm/sec
Interval 10.7 to 128.5
|
109.7 cm/sec
Interval 93.73 to 123.5
|
111.6 cm/sec
Interval 101.4 to 125.5
|
|
Walking Velocity at 3 Months and 6 Months
Forward Walking Velocity at 6 months
|
113.9 cm/sec
Interval 102.0 to 125.7
|
108.4 cm/sec
Interval 89.33 to 124.9
|
117 cm/sec
Interval 104.6 to 126.0
|
|
Walking Velocity at 3 Months and 6 Months
Backward Walking Velocity at 3 months
|
78.8 cm/sec
Interval 60.3 to 95.1
|
67.8 cm/sec
Interval 54.05 to 79.4
|
73.4 cm/sec
Interval 55.05 to 87.95
|
|
Walking Velocity at 3 Months and 6 Months
Backward Walking Velocity at 6 months
|
74.2 cm/sec
Interval 60.4 to 95.8
|
70.3 cm/sec
Interval 44.93 to 81.43
|
68.2 cm/sec
Interval 55.05 to 89.5
|
Adverse Events
Treadmill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tango
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stretching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gammon M. Earhart
Washington University in St. Louis
Phone: 314-286-1407
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place