Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms

NCT ID: NCT01768832

Last Updated: 2018-11-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treadmill

Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.

Group Type EXPERIMENTAL

Treadmill

Intervention Type BEHAVIORAL

Tango

Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.

Group Type EXPERIMENTAL

Tango

Intervention Type BEHAVIORAL

Stretching

Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Stretching

Intervention Type BEHAVIORAL

Interventions

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Treadmill

Intervention Type BEHAVIORAL

Tango

Intervention Type BEHAVIORAL

Stretching

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gammon M Earhart, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30531383 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25652002 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01NS077959-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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