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Telephone-linked Home-based Exercise Training in PD

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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