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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04291027
Other study ID # 711
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 28, 2020
Est. completion date March 10, 2020

Study information

Verified date March 2021
Source Ithaca College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date March 10, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Ithaca College Ithaca New York

Sponsors (2)

Lead Sponsor Collaborator
Ithaca College Parkinson's Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mini-BESTest Score The Mini-BESTest examines postural control. A higher scores means less balance impairment. Prior to intervention, after 12 week intervention
Primary 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. Prior to intervention, after 12 week intervention
Primary Change in Gait Speed 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 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. Prior to intervention, after 12 week intervention
Secondary 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. Prior to intervention, after 12 week intervention
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