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Telephone-linked Home-based Exercise Training in PD

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ClinicalTrials.gov Identifier: NCT02898740
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Structural exercise Behavioral: Health education Phase 3

Detailed Description:

Background/Rationale:

Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.

Objective:

The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.

Methods:

The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Telephone-linked Home-based Exercise Training in PD
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Structured exercise
Behavioral: Structural exercise
Exercise instruction and encouragement

Active Comparator: Arm 2
Health education
Behavioral: Health education
Provision of general information about a variety of health topics




Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ]
    The Ham-D is the most widely used and accepted measure for evaluating depression severity.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Angina pectoris
  • History of myocardial infarction within 6 months
  • History of ventricular dysrhythmia requiring current therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898740


Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02898740     History of Changes
Other Study ID Numbers: E2362-P
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Parkinson's disease
exercise therapy
quality of life

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