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Clinical Trials/NCT02898740
NCT02898740
Completed
N/A

Telephone-linked Home-based Exercise Training in PD

VA Office of Research and Development1 site in 1 country40 target enrollmentFebruary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
VA Office of Research and Development
Enrollment
40
Locations
1
Primary Endpoint
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months

Time Frame: Baseline and 6 months

The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).

Study Sites (1)

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