Telephone-linked Home-based Exercise Training in PD

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Structural exercise; Behavioral: Health education

• Registration Number: NCT02898740
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Study Start: 2017-02-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31
• Status Verified: 2019-10
• Results First Submitted: 2019-10-30
• Results First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Results First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Structural exercise	Structured exercise
Health Education	Health education	Health education

Primary Outcome Measures

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

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States