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

NCT01768832 | Completed Results DMC

• 1 other identifier: 1R01NS077959-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; walking; fMRI; exercise; dance; treadmill

Outcome Measures

Primary Outcomes (1)

• Walking Velocity at Baseline and 3 Months

  Walking velocity during forward and backward walking as determined by a computerized mat.

  0 and 3 months

Secondary Outcomes (8)

• Blood Oxygen Level Dependent Signal at Baseline to 3 Months

  0 and 3 months

• Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months

  0 and 3 months

• PDQ-39 Scores at Baseline and 3 Months

  0 and 3 months

• Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months

  0 and 3 months

• Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months

  3 and 6 months

Study Arms (3)

Treadmill

EXPERIMENTAL

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

Behavioral: Treadmill

Tango

EXPERIMENTAL

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

Behavioral: Tango

Stretching

ACTIVE COMPARATOR

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

Behavioral: Stretching

Interventions

Treadmill BEHAVIORAL

Treadmill

Tango BEHAVIORAL

Tango

Stretching BEHAVIORAL

Stretching

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (2)

• 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.

  PMID: 30531383 DERIVED

• 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.

  PMID: 25652002 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise Test; Aryl Hydrocarbon Receptor Nuclear Translocator

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Nucleocytoplasmic Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Hypoxia-Inducible Factor 1; Basic Helix-Loop-Helix Transcription Factors; DNA-Binding Proteins; Membrane Proteins; Transcription Factors

Results Point of Contact

• Title: Dr. Gammon M. Earhart
• Organization: Washington University in St. Louis

earhartg@wustl.edu

314-286-1407

Study Officials

• Gammon M Earhart, PhD, PT

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 15, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-11

Locations

US (1)