Clinical trial NCT01768832: Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Official title: Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
walking
fMRI
exercise
dance
treadmill
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 119
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Walking Velocity at Baseline and 3 Months
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Blood Oxygen Level Dependent Signal at Baseline to 3 Months
timeFrame: 0 and 3 months
measure: Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
timeFrame: 0 and 3 months
measure: PDQ-39 Scores at Baseline and 3 Months
timeFrame: 0 and 3 months
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months
timeFrame: 0 and 3 months
measure: Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
timeFrame: 3 and 6 months
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months
timeFrame: 3 and 6 months
measure: PDQ-39 Scores at 3 Months and 6 Months
timeFrame: 3 and 6 months
measure: Walking Velocity at 3 Months and 6 Months
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gammon M Earhart, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.