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This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Structured exercise |
|
| Health Education | Active Comparator | Health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structural exercise | Behavioral | Exercise instruction and encouragement |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Structural exercise: Exercise instruction and encouragement |
| FG001 | Health Education | Health education: Provision of general information about a variety of health topics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Structural exercise: Exercise instruction and encouragement |
| BG001 | Health Education | Health education: Provision of general information about a variety of health topics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Full Range | units on a scale | Baseline and 6 months |
|
Baseline to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Structural exercise: Exercise instruction and encouragement | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6400 | david.sparrow@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2018 | Oct 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Health education |
| Behavioral |
Provision of general information about a variety of health topics |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline HAM-D score | 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. | Mean | Full Range | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Health Education | Health education: Provision of general information about a variety of health topics | 0 | 19 | 0 | 19 | 0 | 19 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |