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Completed

NCT Number: NCT04918342

Group Versus Individuals Telehealth Exercise Programs for People 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sarah Fishel

Ithaca, New York, 14850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in "Mini-Balance Evaluation Systems Test" Score

    Time frame: Prior 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.

  2. Change in "Five Times Sit to Stand" test time

    Time frame: Prior 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 outcomes

  1. Change in 10 meter walk test

    Time frame: Prior 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.

  2. Change in Six Minute Walk Test Distance

    Time frame: Prior 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.

  3. Change in Parkinson Disease Questionnaire-39 score

    Time frame: Prior 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.

  4. Change in Self Efficacy for Exercise Scale score

    Time frame: Prior 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.

Sponsors and collaborators

Lead sponsor

Ithaca College

Other

Collaborators

  • Parkinson's Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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