Telephone-linked Home-based Exercise Training in PD

VA Office of Research and Development

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Health education; Behavioral: Structural exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02898740

E2362-P

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Exercise

Experimental group

Description:

Structured exercise

Treatment:

Behavioral: Structural exercise

Health Education

Active Comparator group

Description:

Health education

Treatment:

Behavioral: Health education