A Randomized Trial of BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University of Florida
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change between baseline and 6-month Timed Up and Go test (TUG)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Many patients with Parkinson's Disease (PD) will encounter difficulties with balance, posture, and gait for which physical therapy (PT) has been shown to be beneficial. The purpose of this study is to randomize patients between standard "burst" PT versus "spaced" PT to inform on the optimal frequency of PT for PD patients. Burst PT in this study was defined as 2 PT visits per week for 6 weeks (12 sessions) and spaced PT, as 1 PT visit every other week for 6 months (12 sessions).
Detailed Description
Parkinson's Disease (PD) is a progressive neurodegenerative disorder with a negative impact on quality of life.1 Many patients with PD will encounter difficulties with balance, posture, transfer, gait and physical capacity due to the motor symptoms of the disease.2 For these symptoms, physical therapy (PT) has been shown to be beneficial and clinically useful for the motor symptoms and thus is routinely prescribed alongside medical management. However, despite increasing evidence of the positive effects of physical therapy for patients with PD, there is no standard approach for organizing physiotherapy in the context of multidisciplinary care. Administration of physical therapy as a "burst" of frequent sessions delivered over 4-6 weeks is the most commonly employed strategy in PD patients and is driven largely by the payer system. Burst therapy has been useful in post-stroke and post traumatic brain injury rehabilitation, however, the investigators of this study hypothesize that this approach will be suboptimal in PD when compared to therapy which is "spaced" over a longer period of time. The purpose of this study is to randomize patients between typical "burst" PT versus "spaced" PT to inform on the optimal frequency of PT for PD patients. Burst PT in this study was defined as 2 PT visits per week for 6 weeks (12 sessions) and spaced PT, as 1 PT visit every other week for 6 months (12 sessions). 30 PD patients were recruited as part of a pilot trial to assess the effectiveness of burst vs. spaced physical therapy (the BUS PT trial). Baseline measures were collected on all patients, including the timed up and go test (TUG), the baseline frequency of utilization of PT, falls, fractures, hospitalizations, the 10 meter walk test (10MWT), the Mini Balance Evaluation Systems Test (miniBESTest), objective gait analysis using Gaitrite, the Parkinson's Disease Questionnaire-39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS) "ON" and "OFF" motor scores, the quantitation of the levodopa equivalent daily doses (LEDD), and the Godin Leisure Activity Questionnaire to assess baseline exercise levels. The investigators hypothesized that "spaced" PT is beneficial for maintenance of physical function in PD. Prior collective evidence suggests that long-term continuous exercise in PD patients is associated with positive outcomes, however a spaced PT approach has not been employed. This study will provide useful data that will directly impact payer systems, reimbursements and access to care for PD patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 30-90 years
- •Parkinson's disease as measured by Hoehn \& Yahr stage 2-3
- •Idiopathic Parkinson's Disease patients diagnosed by a Movement Disorder Neurologist
- •Stable dopaminergic medication for 1 month prior to the study and during the study (6 month intervention)
- •Requires ongoing physical therapy as assessed by a physical therapist
Exclusion Criteria
- •Comorbidities including orthopedic injuries or cardiopulmonary disease that would potentially interfere with physical therapy and assessments
- •Severe cognitive impairments (MMSE \<21)
- •Unable to participate in all therapy sessions
Outcomes
Primary Outcomes
Change between baseline and 6-month Timed Up and Go test (TUG)
Time Frame: Baseline up to 6-month follow up
The TUG test is a validated and reliable tool to assess balance and mobility in Parkinson's disease. It has been used as an outcome measure in many trials involving PT and exercise in PD and is frequently included in standard PT visits. Patients wear their regular footwear and can use a walking aid, if needed. Patient starts the test sitting back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. Once examiner says go. the patient has to get up from the chair, walk until the line on the floor, come back and sit down on the chair. Timing begins when examiner says "go" and stops after patients sits back down. An older adult that takes 12 or more seconds to complete the task is at risk for falling.
Secondary Outcomes
- Unified Parkinson's Disease Rating Scale (UPDRS) motor score(Baseline up to 6-month follow up)
- 10 meter walk test (10MWT)(Baseline up to 6-month follow up)
- The Mini Balance Evaluation Systems Test (MiniBesTest)(Baseline up to 6-month follow up)
- Levodopa equivalent daily doses (LEDD)(Baseline up to 6-month follow up)
- Godin Leisure Activity Questionnaire(Baseline up to 6-month follow up)
- Non-motor symptoms PD questionnaire (NMS)(Baseline up to 6-month follow up)
- Objective gait analysis using Gaitrite(Baseline up to 6-month follow up)
- Parkinson's Disease Questionnaire-39 (PDQ39)(Baseline up to 6-month follow up)
- Baseline frequency of utilization of PT(Baseline up to 6-month follow up)
- Falls diary(Baseline up to 6-month follow up)
- Change between 6-week and 6-month Timed Up and Go test (TUG)(6-week follow up (burst group only) and 6-month follow up)