Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

NCT ID: NCT04918342

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2022-08-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individual Exercise Instruction

The participant will receive individual exercise instruction.

Group Type: ACTIVE_COMPARATOR

Multidimensional Exercise Program

Intervention Type: OTHER

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.

Group Exercise Instruction

The participant will receive the instruction in a group of up to 9 other participants.

Group Type: EXPERIMENTAL

Multidimensional Exercise Program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ithaca College

OTHER

Sponsor Role: lead

Parkinson's Foundation

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Fishel

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

Sarah Fishel

Ithaca, New York, United States

Countries

United States

Other Identifiers

271

Identifier Type: -

Identifier Source: org_study_id