Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918342
• Other study ID #: 271
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Ithaca College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Sarah Fishel	Ithaca	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ithaca College	Parkinson's Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.