Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Multidimensional Exercise Program

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14850
      • Sarah Fishel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Individual Exercise Instruction; The participant will receive individual exercise instruction.	Other: Multidimensional Exercise Program; 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.
Experimental: Group Exercise Instruction; The participant will receive the instruction in a group of up to 9 other participants.	Other: Multidimensional Exercise Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Prior to and after the 8 week intervention.
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.	Prior to and after the 8 week intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Prior to and after 8 week intervention.
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.	Prior to and after 8 week intervention.
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.	Prior to and after 8 week intervention.
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.	Prior to and after 8 week intervention.

Collaborators and Investigators

• Sponsor: Ithaca College
• Collaborators: Parkinson's Foundation
• Investigators: Principal Investigator: Sarah Fishel, Faculty

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No