Aquatic Group Exercise for People With Parkinson Disease

Sponsor

Ithaca College (Other)

Overall Status

Terminated

CT.gov ID

NCT04291027

Collaborator

Parkinson's Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Days)

13.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Land Based Exercise Other: Aquatic Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 28, 2020

Actual Primary Completion Date :

Mar 10, 2020

Actual Study Completion Date :

Mar 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aquatic Group Exercise	Other: Aquatic 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	Other: Land Based 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.

Arm

Intervention/Treatment

Experimental: Aquatic Group Exercise

Other: Aquatic 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

Other: Land Based 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.

Outcome Measures

Primary Outcome Measures

Change in Mini-BESTest Score [Prior to intervention, after 12 week intervention]
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 [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.
Change in Gait Speed [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.

Secondary Outcome Measures

Change in Parkinson Disease Questionnaire-39 (PDQ-39) [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.
Change in Falls Efficacy Scale-International. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

Ithaca College
Parkinson's Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah Fishel, Assistant Professor, Ithaca College

ClinicalTrials.gov Identifier:

NCT04291027

Other Study ID Numbers:

First Posted:

Mar 2, 2020

Last Update Posted:

Apr 5, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Apr 5, 2021