Clinical trial NCT05180747: BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Timing Trial
Official title: A Randomized Trial of BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Physical Therapy
Time Up and Go
Spaced Physical Therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change between baseline and 6-month Timed Up and Go test (TUG)
timeFrame: Baseline up to 6-month follow up
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) motor score
timeFrame: Baseline up to 6-month follow up
measure: The Mini Balance Evaluation Systems Test (MiniBesTest)
timeFrame: Baseline up to 6-month follow up
measure: 10 meter walk test (10MWT)
timeFrame: Baseline up to 6-month follow up
measure: Non-motor symptoms PD questionnaire (NMS)
timeFrame: Baseline up to 6-month follow up
measure: Parkinson's Disease Questionnaire-39 (PDQ39)
timeFrame: Baseline up to 6-month follow up
measure: Levodopa equivalent daily doses (LEDD)
timeFrame: Baseline up to 6-month follow up
measure: Baseline frequency of utilization of PT
timeFrame: Baseline up to 6-month follow up
measure: Objective gait analysis using Gaitrite
timeFrame: Baseline up to 6-month follow up
measure: Falls diary
timeFrame: Baseline up to 6-month follow up
measure: Godin Leisure Activity Questionnaire
timeFrame: Baseline up to 6-month follow up
measure: Change between 6-week and 6-month Timed Up and Go test (TUG)
timeFrame: 6-week follow up (burst group only) and 6-month follow up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Norman Fixel Institute for Neurological Diseases
state: Florida
Study officials:
affiliation: University of Kansas Medical Center
name: Ka Loong Kelvin Au, MD
role: PRINCIPAL_INVESTIGATOR
References: