Group Versus Individuals Telehealth Exercise Programs for People With Parkinson Disease

Sponsor
Ithaca College (Other)
Overall Status
Completed
CT.gov ID
NCT04918342
Collaborator
Parkinson's Foundation (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multidimensional Exercise Program
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be assigned to either exercise individually with a physical therapist or in a group.Participants will be assigned to either exercise individually with a physical therapist or in a group.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease
Actual Study Start Date :
Jun 7, 2021
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Individual Exercise Instruction

The participant will receive individual exercise instruction.

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.

Experimental: Group Exercise Instruction

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

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.

Outcome Measures

Primary Outcome Measures

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

  1. Change in 10 meter walk test [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sarah Fishel Ithaca New York United States 14850

Sponsors and Collaborators

  • Ithaca College
  • Parkinson's Foundation

Investigators

  • Principal Investigator: Sarah Fishel, Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ithaca College
ClinicalTrials.gov Identifier:
NCT04918342
Other Study ID Numbers:
  • 271
First Posted:
Jun 8, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022