Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2017-02-01
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telemedicine Intervention to Improve Cognitive Function
NCT02248649
Telemedicine Intervention to Improve Physical Function
NCT01639469
Exercise Study For People With Parkinson's Disease
NCT00387218
Effect of Exercise in Parkinsonism
NCT02598973
The Effect of Exercise on Individuals With Parkinson's Disease
NCT00591344
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise
Structured exercise
Structural exercise
Exercise instruction and encouragement
Health Education
Health education
Health education
Provision of general information about a variety of health topics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Structural exercise
Exercise instruction and encouragement
Health education
Provision of general information about a variety of health topics
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 2 of 3 cardial signs of PD
* Response to dopaminergic medication
* Depression
Exclusion Criteria
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David W Sparrow, DSc
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2362-P
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.