Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Exercise therapy, Accidental falls
Brief summary
This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.
Detailed description
Background/Rationale. Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD include resting tremor, rigidity, bradykinesia, and postural instability/gait disturbance. In addition, people with PD fall frequently, with 60% falling annually and two-thirds of these falling recurrently. Identifying interventions that successfully improve postural control and reduce fall rate is critical to reduce disability, improve quality of life, and potentially increase survival in patients with PD. Recent randomized, controlled trials (RCT) have examined the effects of exercise and physical therapy interventions on reducing falls in patients with PD; however, with mixed results. Objectives. There is a limited availability of effective treatment options to reduce falls in PD. In this context, some studies suggest that highly challenging exercise approaches may lead to better outcomes. The investigators propose investigating the effects of two theoretically driven, progressive, highly challenging exercise programs: 1) a structured exercise program at the VA and 2) a structured exercise program at home. There will also be a control group in which health education is provided. Methods. The investigators propose to conduct an RCT evaluating effects on fall rate. A total of 162 VA patients with mild-to-moderate PD will be randomly assigned to one of the three 3-month interventions: in-person exercise at the VA, remotely-delivered exercise, or health education. Outcomes will be compared between each intervention group and the control group. Fall rates will be compared between groups with the use of negative binomial regression models.
Interventions
BEHAVIORALFacility-based structured exercise
Structured exercise program in a facility with instruction and encouragement
BEHAVIORALHome-based structured exercise
Structured exercise program in the home with instruction and encouragement
BEHAVIORALHealth education
Provision of general information about a variety of 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 89 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of idiopathic PD * At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia) * Response to dopaminergic medication
Exclusion criteria
* Angina pectoris * History of myocardial infarction (MI) within 6 months * History of ventricular dysrhythmia requiring current therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Falls Over 3 Month Period | Baseline to 3 months | Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Falls Over 6 Month Period | Baseline to 6 months | Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-person Exercise Group facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement | 51 |
| Remote Exercise Group home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement | 58 |
| Control Group health education
Health education: Provision of general information about a variety of topics | 53 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 3-month Follow-up | Death | 1 | 1 | 0 |
| 6-month Follow-up | Death | 1 | 1 | 1 |
| 6-month Follow-up | Lost to Follow-up | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | In-person Exercise Group | Remote Exercise Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 7 | 76.2 years STANDARD_DEVIATION 7.2 | 73.2 years STANDARD_DEVIATION 7.7 | 74.4 years STANDARD_DEVIATION 7.4 |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Non-Hispanic | 51 Participants | 58 Participants | 51 Participants | 160 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 51 Participants | 57 Participants | 52 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 51 | 2 / 58 | 1 / 53 |
| other Total, other adverse events | 0 / 51 | 0 / 58 | 0 / 53 |
| serious Total, serious adverse events | 0 / 51 | 0 / 58 | 0 / 53 |
Outcome results
Primary
Number of Falls Over 3 Month Period
Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Exercise Group | Number of Falls Over 3 Month Period | 1.1 number of falls | Standard Deviation 2.7 |
| Remote Exercise Group | Number of Falls Over 3 Month Period | 1.6 number of falls | Standard Deviation 3 |
| Control Group | Number of Falls Over 3 Month Period | 9.7 number of falls | Standard Deviation 48.4 |
p-value: <0.0595% CI: [0.05, 0.32]negative binomial regression
p-value: <0.0595% CI: [0.1, 0.61]negative binomial regression
p-value: <0.0595% CI: [0.19, 1.38]negative binomial regression
Secondary
Number of Falls Over 6 Month Period
Total number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-person Exercise Group | Number of Falls Over 6 Month Period | 2.08 number of falls | Standard Deviation 3.46 |
| Remote Exercise Group | Number of Falls Over 6 Month Period | 3.02 number of falls | Standard Deviation 6.32 |
| Control Group | Number of Falls Over 6 Month Period | 11.36 number of falls | Standard Deviation 49.55 |
p-value: <0.0595% CI: [0.07, 0.33]negative binomial regression
p-value: <0.0595% CI: [0.11, 0.58]negative binomial regression
p-value: <0.0595% CI: [0.25, 1.38]negative binomial regression