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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04918342
Enrollment
20
Registered
2021-06-08
Start date
2021-06-07
Completion date
2022-08-01
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

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.

Sponsors

Parkinson's Foundation
CollaboratorOTHER
Ithaca College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants will be assigned to either exercise individually with a physical therapist or in a group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Mini-Balance Evaluation Systems Test ScorePrior to and after the 8 week intervention.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 timePrior to and after the 8 week intervention.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

MeasureTime frameDescription
Change in 10 meter walk testPrior to and after 8 week intervention.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 DistancePrior to and after 8 week intervention.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 scorePrior to and after 8 week intervention.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 scorePrior to and after 8 week intervention.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026