Clinical trial NCT04918342: Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease
Official title: Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Ithaca College
Sponsor class: OTHER
Collaborators: name: Parkinson's Foundation
First posted: 2021-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either exercise individually with a physical therapist or in a group.
Primary purpose: TREATMENT

Brief summary: This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

Detailed description: This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

Eligibility criteria: Inclusion Criteria:

* have a diagnosis of idiopathic Parkinson disease
* been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
* be able to walk independently
* have a referral from a physician to participate in the program
* have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform

Exclusion Criteria:

* have any other neurological condition other than Parkinson disease
* have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
* demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
* have any musculoskeletal condition that affected their ability to participate in the exercise group
* score less than 24/30 on the Mini Mental Status Examination during the initial evaluation

Primary outcomes:
measure: Change in "Mini-Balance Evaluation Systems Test" Score
timeFrame: Prior to and after the 8 week intervention.
measure: Change in "Five Times Sit to Stand" test time
timeFrame: Prior to and after the 8 week intervention.
Secondary outcomes:
measure: Change in 10 meter walk test
timeFrame: Prior to and after 8 week intervention.
measure: Change in Six Minute Walk Test Distance
timeFrame: Prior to and after 8 week intervention.
measure: Change in Parkinson Disease Questionnaire-39 score
timeFrame: Prior to and after 8 week intervention.
measure: Change in Self Efficacy for Exercise Scale score
timeFrame: Prior to and after 8 week intervention.
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Sarah Fishel
state: New York
Study officials:
affiliation: Faculty
name: Sarah Fishel
role: PRINCIPAL_INVESTIGATOR
References: