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Telemedicine Intervention to Improve Physical Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01639469
First received: July 10, 2012
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life in patients with Parkinson's disease.


Condition Intervention Phase
Parkinson's Disease
Behavioral: Structured exercise
Behavioral: Lifestyle exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Telemedicine Intervention to Improve Physical Function in Patients With PD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fall rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Total number of falls over the 1-year follow-up


Estimated Enrollment: 158
Study Start Date: January 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Structured exercise
Structured exercise instruction by smartphone
Behavioral: Structured exercise
Structured exercise includes stretching, strengthening, and balance exercises.
Active Comparator: lifestyle exercise
Lifestyle exercise program taught via smartphone
Behavioral: Lifestyle exercise
Subjects will be taught lifestyle exercises and advised about mobility strategies

Detailed Description:

Background/Rationale:

Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD are motoric, which limit functional mobility leading to difficulty working, caring for family members, managing a household, and overall decreased independence and quality of life (QOL). A wealth of growing data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established.

Objective:

We hypothesize that a one-year in-home exercise program, centered around remote, real-time instruction and supervision, will reduce the rate of falls and improve strength and QOL in patients with PD.

Methods:

The proposed study is a randomized controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. Community-dwelling people with PD will be randomized either to a group who receives structured and remote exercise instruction and supervision in real-time or a group who is taught a lifestyle exercise program. Subjects will be male and female veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, and response to dopaminergic medication. The interventions will last one year.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
  • At least 2 of 3 cardinal signs of PD
  • Response to dopaminergic medication

Exclusion Criteria:

  • Angina pectoris
  • History of myocardial infarction within 6 months
  • History of ventricular dysrhythmia requiring current therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639469

Contacts
Contact: David W Sparrow, DSc (857) 364-6400 ext 46400 David.Sparrow@va.gov

Locations
United States, Massachusetts
VA Boston Health Care System Recruiting
Boston, Massachusetts, United States, 02130
Contact: David W Sparrow, DSc    (857) 364-6400 ext 46400    David.Sparrow@va.gov   
Principal Investigator: David William Sparrow, DSc         
Sponsors and Collaborators
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01639469     History of Changes
Other Study ID Numbers: IIR 11-342
Study First Received: July 10, 2012
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Parkinson Disease
Quality of Life
Exercise Therapy

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

ClinicalTrials.gov processed this record on November 25, 2014