- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291027
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
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 711 (Ct Surgery Network Research Group)
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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