Parkinson's Disease
Conditions
Keywords
Parkinson's disease, exercise therapy, quality of life
Brief summary
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
Detailed 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.
Interventions
BEHAVIORALStructural exercise
Exercise instruction and encouragement
BEHAVIORALHealth education
Provision of general information about a variety of health topics
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months | Baseline and 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Structural exercise: Exercise instruction and encouragement | 21 |
| Health Education Health education: Provision of general information about a variety of health topics | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Exercise | Health Education | Total |
|---|---|---|---|
| Age, Continuous | 70.7 years | 69.3 years | 70.0 years |
| Baseline HAM-D score | 10.7 years | 9.8 years | 10.3 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
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).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise | Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months | -1.4 units on a scale |
| Health Education | Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months | 2.0 units on a scale |
p-value: <0.0595% CI: [-6.8, 0]Mixed Models Analysis