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Highly Challenging Balance Program to Reduce Fall Rate in PD
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease | Behavioral: Facility-based structured exercise Behavioral: Home-based structured exercise Behavioral: Health education | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 162 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | Highly Challenging Balance Program to Reduce Fall Rate in PD |
| Actual Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | February 28, 2023 |
| Estimated Study Completion Date : | July 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: In-person exercise group
facility-based structured exercise program
|
Behavioral: Facility-based structured exercise
Structured exercise program in a facility with instruction and encouragement
|
|
Experimental: Remote exercise group
home-based structured exercise program
|
Behavioral: Home-based structured exercise
Structured exercise program in the home with instruction and encouragement
|
|
Active Comparator: Control group
health education
|
Behavioral: Health education
Provision of general information about a variety of topics
|
- Falls [ Time Frame: 3 months ]Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
- Falls [ Time Frame: 6 months ]Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
| Ages Eligible for Study: | 40 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
| Contact: David W Sparrow, DSc | (857) 364-6400 ext 46400 | David.Sparrow@va.gov |
| United States, Massachusetts | |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: David W Sparrow, DSc (857) 364-6400 ext 46400 David.Sparrow@va.gov | |
| Principal Investigator: David William Sparrow, DSc | |
| Principal Investigator: | David William Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||||
| First Posted Date ICMJE | June 4, 2019 | ||||||
| Last Update Posted Date | February 15, 2021 | ||||||
| Actual Study Start Date ICMJE | October 1, 2019 | ||||||
| Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Falls [ Time Frame: 3 months ] Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
Falls [ Time Frame: 6 months ] Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Highly Challenging Balance Program to Reduce Fall Rate in PD | ||||||
| Official Title ICMJE | Highly Challenging Balance Program to Reduce Fall Rate in PD | ||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Other |
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| Condition ICMJE | Parkinson's Disease | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
162 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | July 31, 2023 | ||||||
| Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 89 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03972969 | ||||||
| Other Study ID Numbers ICMJE | E3055-R | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||
| Verification Date | February 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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