Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

NCT04918342 | Completed

• 1 other identifier: 271
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in 10 meter walk test

  Prior to and after 8 week intervention.

• Change in Six Minute Walk Test Distance

  Prior to and after 8 week intervention.

• Change in Parkinson Disease Questionnaire-39 score

  Prior to and after 8 week intervention.

• Change in Self Efficacy for Exercise Scale score

  Prior to and after 8 week intervention.

Study Arms (2)

Individual Exercise Instruction

ACTIVE COMPARATOR

The participant will receive individual exercise instruction.

Other: Multidimensional Exercise Program

Group Exercise Instruction

EXPERIMENTAL

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

Other: Multidimensional Exercise Program

Interventions

Multidimensional Exercise Program 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; Individual Exercise Instruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ithaca College: lead
• Parkinson's Foundation: collaborator

Study Sites (1)

Sarah Fishel

Ithaca, New York, 14850, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sarah Fishel

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: June 7, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (1)