Telephone-linked Home-based Exercise Training in PD
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|ClinicalTrials.gov Identifier: NCT02898740|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: Structural exercise Behavioral: Health education||Phase 3|
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.
The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Telephone-linked Home-based Exercise Training in PD|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Arm 1
Behavioral: Structural exercise
Exercise instruction and encouragement
Active Comparator: Arm 2
Behavioral: Health education
Provision of general information about a variety of health topics
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ]The Ham-D is the most widely used and accepted measure for evaluating depression severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898740
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||David William Sparrow, DSc||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|