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Aquatic Group Exercise for People With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Land Based Exercise
Aquatic Exercise
Sponsored by
Ithaca College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease.
  • stable dose of levadopa medication for 30 days prior to study initiation
  • able to walk 20 feet without physical assistance
  • a referral from a physician to participate in physical therapy

Exclusion Criteria:

individuals with:

  • uncontrolled cardiovascular or pulmonary conditions
  • deep vein thrombosis in the last 6 months
  • the use of breathing tube or feeding tube
  • those with an extreme fear of exercising in the water
  • an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease
  • a musculoskeletal condition that would impact their ability to participate in the exercise group
  • cognitive impairment (a score of less than 24/30 on the Mini Mental Status Examination)

Sites / Locations

  • Ithaca College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aquatic Group Exercise

Land Based Group Exercise

Arm Description

Outcomes

Primary Outcome Measures

Change in Mini-BESTest Score
The Mini-BESTest examines postural control. A higher scores means less balance impairment.
Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
The Movement Disorders Society-Unified Parkinson Disease Rating Scale examines motor function for people with Parkinson disease. A higher score indicates higher motor impairment related to Parkinson disease.
Change in Gait Speed
The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.

Secondary Outcome Measures

Change in Parkinson Disease Questionnaire-39 (PDQ-39)
The Parkinson disease questionnaire-39 measures quality of life for people with Parkinson disease. A higher score means more quality of life limitations related to Parkinson disease.
Change in Falls Efficacy Scale-International.
The Falls Efficacy Scale-International measures a person's balance confidence. A higher score is related to worse balance confidence.

Full Information

First Posted
February 26, 2020
Last Updated
March 31, 2021
Sponsor
Ithaca College
Collaborators
Parkinson's Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04291027
Brief Title
Aquatic Group Exercise for People With Parkinson Disease
Official Title
Comparison of Aquatic and Land-based Group Exercise for Individuals With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The study needed to be stopped due to the COVID-19 pandemic.
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ithaca College
Collaborators
Parkinson's Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Participants will be randomized to participate in a land based or aquatic based group exercise program 2 times per week for 12 weeks. Prior to and after participation, balance, walking, quality of life, and balance confidence will be measured by a blinded examiner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Group Exercise
Arm Type
Experimental
Arm Title
Land Based Group Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Land Based Exercise
Intervention Description
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
Intervention Type
Other
Intervention Name(s)
Aquatic Exercise
Intervention Description
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
Primary Outcome Measure Information:
Title
Change in Mini-BESTest Score
Description
The Mini-BESTest examines postural control. A higher scores means less balance impairment.
Time Frame
Prior to intervention, after 12 week intervention
Title
Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
Description
The Movement Disorders Society-Unified Parkinson Disease Rating Scale examines motor function for people with Parkinson disease. A higher score indicates higher motor impairment related to Parkinson disease.
Time Frame
Prior to intervention, after 12 week intervention
Title
Change in Gait Speed
Description
The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.
Time Frame
Prior to intervention, after 12 week intervention
Secondary Outcome Measure Information:
Title
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
Description
The Parkinson disease questionnaire-39 measures quality of life for people with Parkinson disease. A higher score means more quality of life limitations related to Parkinson disease.
Time Frame
Prior to intervention, after 12 week intervention
Title
Change in Falls Efficacy Scale-International.
Description
The Falls Efficacy Scale-International measures a person's balance confidence. A higher score is related to worse balance confidence.
Time Frame
Prior to intervention, after 12 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease. stable dose of levadopa medication for 30 days prior to study initiation able to walk 20 feet without physical assistance a referral from a physician to participate in physical therapy Exclusion Criteria: individuals with: uncontrolled cardiovascular or pulmonary conditions deep vein thrombosis in the last 6 months the use of breathing tube or feeding tube those with an extreme fear of exercising in the water an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease a musculoskeletal condition that would impact their ability to participate in the exercise group cognitive impairment (a score of less than 24/30 on the Mini Mental Status Examination)
Facility Information:
Facility Name
Ithaca College
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Aquatic Group Exercise for People With Parkinson Disease

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