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Clinical Trials/NCT04291027
NCT04291027TerminatedNot Applicable

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

Ithaca College1 site in 1 country5 target enrollmentStarted: February 28, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
Change in Mini-BESTest Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Aquatic Group Exercise

Experimental

Intervention: Aquatic Exercise (Other)

Land Based Group Exercise

Active Comparator

Intervention: Land Based Exercise (Other)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Change in Parkinson Disease Questionnaire-39 (PDQ-39)(Prior to intervention, after 12 week intervention)
  • Change in Falls Efficacy Scale-International.(Prior to intervention, after 12 week intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Fishel

Assistant Professor

Ithaca College

Study Sites (1)

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