Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Exercise therapy, Mild cognitive impairment
Brief summary
This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.
Detailed description
Background/Rationale: Progressive cognitive impairment leading to dementia is an important component of Parkinson's disease (PD), contributing to significant levels of disability. The number of Veterans who will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely to increase substantially. Given the profound negative health and social consequences associated with the development of dementia, it is critical to identify interventions that effectively slow the decline of cognitive function to prolong the time to onset of dementia. Based on the results of prior studies, physical activity is one of the few nonpharmacological interventions that holds promise in slowing cognitive decline. Objective: The investigators hypothesize that a home-based physical activity intervention to promote walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD (PD-MCI). Methods: The proposed study is a randomized, controlled trial of a home-based walking intervention, evaluating effects on cognitive function. Community-dwelling Veterans with PD-MCI will be randomized to a walking intervention or a health education control intervention. 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, response to dopaminergic medication, and MCI. The interventions will last 18 months.
Interventions
BEHAVIORALStructured physical activity
Walking 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 cardinal signs of PD * Response to dopaminergic medication * Mild cognitive impairment
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 From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6 | Baseline and 6 months | The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12 | Baseline and 12 months | The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline. |
| Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18 | Baseline and 18 month | The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Structured walking program
Structured physical activity: Walking instruction and encouragement | 80 |
| Control Health education attention control
Health education: Provision of general information about a variety of health topics
Provision of general information about a variety of health | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 11 |
| Overall Study | Lost to Follow-up | 14 | 10 |
Baseline characteristics
| Characteristic | Physical Activity | Total | Control |
|---|---|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 8.6 | 74.7 years STANDARD_DEVIATION 8.4 | 74.6 years STANDARD_DEVIATION 8.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 80 Participants | 160 Participants | 80 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 78 Participants | 158 Participants | 80 Participants |
| Years of education | 13.6 years STANDARD_DEVIATION 2.8 | 13.8 years STANDARD_DEVIATION 2.7 | 14.1 years STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 80 | 11 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 7 / 80 | 11 / 80 |
Outcome results
Primary
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.
Time frame: Baseline and 6 months
Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 6 months. 4 participants in Physical Activity group and 6 participants in Control group did not have a score at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6 | -0.24 score on a scale | Standard Error 0.62 |
| Control | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6 | 0.95 score on a scale | Standard Error 0.78 |
p-value: 0.2Mixed Models Analysis
Secondary
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.
Time frame: Baseline and 12 months
Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 12 months. 17 participants in Physical Activity group and 15 participants in Control group did not have a score at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12 | 0.12 units on a scale | Standard Error 0.79 |
| Control | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12 | 2.60 units on a scale | Standard Error 0.91 |
p-value: 0.04Mixed Models Analysis
Secondary
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.
Time frame: Baseline and 18 month
Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 18 months. 21 participants in Physical Activity group and 21 participants in Control group did not have a score at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18 | 0.40 units on a scale | Standard Error 0.99 |
| Control | Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18 | 3.60 units on a scale | Standard Error 1.03 |
p-value: 0.02Mixed Models Analysis