Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multidimensional Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
Sites / Locations
- Sarah Fishel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Individual Exercise Instruction
Group Exercise Instruction
Arm Description
The participant will receive individual exercise instruction.
The participant will receive the instruction in a group of up to 9 other participants.
Outcomes
Primary Outcome Measures
Change in "Mini-Balance Evaluation Systems Test" Score
This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.
Change in "Five Times Sit to Stand" test time
For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.
Secondary Outcome Measures
Change in 10 meter walk test
This outcome measure examines gait speed at comfortable and fast speeds. This will be performed using the Gait Rite mat which will collect information about gait characteristics, including step length, step width, and gait symmetry as well. A faster time is associated with better balance and walking ability.
Change in Six Minute Walk Test Distance
This outcome examines gait endurance by measuring the distance walked over 6 minutes on a level surface. A greater number of meters on the test is associated with better walking endurance.
Change in Parkinson Disease Questionnaire-39 score
This is a self report quality of life measure designed for individuals with Parkinson disease. There are 8 subsections which can be reported individually and the score can be calculated as a summary score out of 100%. A lower percentage is associated with lower disability related to Parkinson disease.
Change in Self Efficacy for Exercise Scale score
This measures a person's confidence that they will exercise in a variety of situations.The score ranges from 0 to 90 with a higher score associated with a higher self efficacy for exercise behavior.
Full Information
NCT ID
NCT04918342
First Posted
June 1, 2021
Last Updated
August 2, 2022
Sponsor
Ithaca College
Collaborators
Parkinson's Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04918342
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ithaca College
Collaborators
Parkinson's Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either exercise individually with a physical therapist or in a group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual Exercise Instruction
Arm Type
Active Comparator
Arm Description
The participant will receive individual exercise instruction.
Arm Title
Group Exercise Instruction
Arm Type
Experimental
Arm Description
The participant will receive the instruction in a group of up to 9 other participants.
Intervention Type
Other
Intervention Name(s)
Multidimensional Exercise Program
Intervention Description
The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.
Primary Outcome Measure Information:
Title
Change in "Mini-Balance Evaluation Systems Test" Score
Description
This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.
Time Frame
Prior to and after the 8 week intervention.
Title
Change in "Five Times Sit to Stand" test time
Description
For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.
Time Frame
Prior to and after the 8 week intervention.
Secondary Outcome Measure Information:
Title
Change in 10 meter walk test
Description
This outcome measure examines gait speed at comfortable and fast speeds. This will be performed using the Gait Rite mat which will collect information about gait characteristics, including step length, step width, and gait symmetry as well. A faster time is associated with better balance and walking ability.
Time Frame
Prior to and after 8 week intervention.
Title
Change in Six Minute Walk Test Distance
Description
This outcome examines gait endurance by measuring the distance walked over 6 minutes on a level surface. A greater number of meters on the test is associated with better walking endurance.
Time Frame
Prior to and after 8 week intervention.
Title
Change in Parkinson Disease Questionnaire-39 score
Description
This is a self report quality of life measure designed for individuals with Parkinson disease. There are 8 subsections which can be reported individually and the score can be calculated as a summary score out of 100%. A lower percentage is associated with lower disability related to Parkinson disease.
Time Frame
Prior to and after 8 week intervention.
Title
Change in Self Efficacy for Exercise Scale score
Description
This measures a person's confidence that they will exercise in a variety of situations.The score ranges from 0 to 90 with a higher score associated with a higher self efficacy for exercise behavior.
Time Frame
Prior to and after 8 week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Fishel
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah Fishel
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
12. IPD Sharing Statement
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Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease
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