Aquatic Group Exercise for People With Parkinson Disease

March 31, 2021 updated by: Sarah Fishel, Ithaca College

Comparison of Aquatic and Land-based Group Exercise for Individuals With Parkinson Disease

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Ithaca, New York, United States, 14850
        • Ithaca College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aquatic Group Exercise
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
Active Comparator: Land Based Group Exercise
Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini-BESTest Score
Time Frame: Prior to intervention, after 12 week intervention
The Mini-BESTest examines postural control. A higher scores means less balance impairment.
Prior to intervention, after 12 week intervention
Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III
Time Frame: Prior to intervention, after 12 week intervention
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.
Prior to intervention, after 12 week intervention
Change in Gait Speed
Time Frame: Prior to intervention, after 12 week intervention
The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.
Prior to intervention, after 12 week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
Time Frame: Prior to intervention, after 12 week intervention
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.
Prior to intervention, after 12 week intervention
Change in Falls Efficacy Scale-International.
Time Frame: Prior to intervention, after 12 week intervention
The Falls Efficacy Scale-International measures a person's balance confidence. A higher score is related to worse balance confidence.
Prior to intervention, after 12 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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