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

This study is currently recruiting participants.
Verified June 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01768832
First received: January 8, 2013
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Behavioral: Treadmill
Behavioral: Tango
Behavioral: Stretching
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in Walking Velocity from Baseline to 3 Months [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    Walking velocity during forward and backward walking as determined by a computerized mat.


Secondary Outcome Measures:
  • Change in Blood oxygen level dependent signal from baseline to 3 months [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    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.

  • Change in Mini Balance Evaluation Systems Test (Mini-BESTest) from baseline to 3 months [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    Clinical assessment of balance ability

  • Change in PDQ-39 from baseline to 3 months [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    Quality of life questionnaire

  • Change in Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III from baseline to 3 months [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    Standardized rating of motor symptom severity in Parkinson disease.

  • Change in Mini Balance Evaluation Systems Test (Mini-BESTest) from 3 to 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Clinical assessment of balance ability

  • Change in Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III from 3 months to 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Standardized rating of motor symptom severity in Parkinson disease.

  • Change in PDQ-39 from 3 months to 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Quality of life questionnaire

  • Change in walking velocity from 3 months to 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Walking velocity during forward and backward walking as determined by a computerized mat.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treadmill
40 individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Behavioral: Treadmill
Experimental: Tango
40 individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Behavioral: Tango
Active Comparator: Stretching
40 individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Behavioral: Stretching

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768832

Contacts
Contact: Martha Hessler 314-286-1478 hesslerm@wusm.wustl.edu
Contact: Gammon M Earhart, PhD, PT 314-286-1425 earhartg@wusm.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63108
Contact: Martha Hessler    314-286-1478    hesslerm@wusm.wustl.edu   
Contact: Ryan P Duncan, PT, DPT    314-286-1478    duncanr@wusm.wustl.edu   
Principal Investigator: Gammon M Earhart, PhD, PT         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Gammon M Earhart, PhD, PT Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01768832     History of Changes
Other Study ID Numbers: 1R01NS077959-01A1
Study First Received: January 8, 2013
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Parkinson disease
walking
fMRI
exercise
dance
treadmill

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 17, 2014