N/A
N=119
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01768832 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Walking Velocity at Baseline and 3 Months — 103.28; 104.53; 111.21; 109.57 cm/sec
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treadmill (Behavioral); Tango (Behavioral); Stretching (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Walking Velocity at Baseline and 3 Months |
103.28; 104.53; 111.21; 109.57; 103.36; 110.52 | — |
| SECONDARY Blood Oxygen Level Dependent Signal at Baseline to 3 Months |
.110; .043; .095; .126; .111; .117 | — |
| SECONDARY Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months |
19; 19; 20; 19; 19; 21 | — |
| SECONDARY PDQ-39 Scores at Baseline and 3 Months |
19.22; 18.33; 16.30; 17.86; 18.80; 16.39 | — |
| SECONDARY Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months |
37; 37; 38; 33; 33; 33 | — |
| SECONDARY Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months |
20; 20; 21; 20; 19; 20 | — |
| SECONDARY Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months |
32; 32; 33; 32; 35; 38 | — |
| SECONDARY PDQ-39 Scores at 3 Months and 6 Months |
17.86; 18.80; 16.39; 12.66; 19.20; 9.33 | — |
| SECONDARY Walking Velocity at 3 Months and 6 Months |
116.7; 109.7; 111.6; 113.9; 108.4; 117 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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),
- no history of vestibular disease, 7) no evidence of dementia
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01768832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.