Telephone-linked Home-based Exercise Training in PD

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

Detailed Description
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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.

Official Title
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Telephone-linked Home-based Exercise Training in PD

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Structural exercise
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Structured exercise | Behavioral: Structural exercise<br>* Exercise instruction and encouragement<br>|
| Active Comparator: Health Education<br>Health education | Behavioral: Health education<br>* Provision of general information about a variety of health topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 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). | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, exercise therapy, quality of life