Parkinson's Disease
Conditions
Keywords
Parkinson Disease, Quality of Life, Exercise Therapy
Brief summary
This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life 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 are motoric, which limit functional mobility leading to difficulty working, caring for family members, managing a household, and overall decreased independence and quality of life (QOL). A wealth of growing data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established. Objective: The investigators hypothesize that a one-year in-home exercise program, centered around remote, real-time instruction and supervision, will reduce the rate of falls and improve strength and QOL in patients with PD. Methods: The proposed study is a randomized controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. Community-dwelling people with PD will be randomized either to a group who receives structured and remote exercise instruction and supervision in real-time or a group who is taught a lifestyle exercise program. Subjects will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, and response to dopaminergic medication. The interventions will last one year.
Interventions
BEHAVIORALStructured exercise
Structured exercise includes stretching, strengthening, and balance exercises.
BEHAVIORALLifestyle exercise
Subjects will be taught lifestyle exercises and advised about mobility strategies
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 cardinal signs of PD * Response to dopaminergic medication
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 |
|---|---|---|
| Total Falls During the 1-year Follow-up | up to 1 year | Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Structured Exercise Structured exercise instruction by smartphone
Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises. | 89 |
| Lifestyle Exercise Lifestyle exercise program taught via smartphone
Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies | 80 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Structured Exercise | Lifestyle Exercise | Total |
|---|---|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 9.4 | 72.7 years STANDARD_DEVIATION 9.8 | 72.1 years STANDARD_DEVIATION 9.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 87 Participants | 78 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 89 | 2 / 80 |
| other Total, other adverse events | 0 / 89 | 0 / 80 |
| serious Total, serious adverse events | 4 / 89 | 2 / 80 |
Outcome results
Primary
Total Falls During the 1-year Follow-up
Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.
Time frame: up to 1 year
Population: 2 participants not analyzed were excluded due to early loss to follow-up and had no fall data collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Structured Exercise | Total Falls During the 1-year Follow-up | 1026 Total count of falls |
| Lifestyle Exercise | Total Falls During the 1-year Follow-up | 1861 Total count of falls |
Comparison: Testing to see if there is a significant difference in fall rates over 12months between the two groups.p-value: <0.00195% CI: [0.22, 0.68]Negative Binomial Regression