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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04228887
Date of registration: 05/08/2019
Prospective Registration: No
Primary sponsor: Bezmialem Vakif University
Public title: Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
Scientific title: Effects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's Disease
Date of first enrolment: May 4, 2018
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT04228887
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Turkey
Contacts
Name:     Hülya N Gürses, Prof
Address: 
Telephone:
Email:
Affiliation:  Bezmialem Vakif University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with Parkinson'S Disease

- Ages between 60 and 85 years

- Grades 1 to 3 according to Modified Hoehn-Yahr Scale

Exclusion Criteria:

- Lung surgery or diagnosed lung disease history

- Dementia

- Having a orthopedic disorder which may affect balance and/or mobility

- Severe dyskinesia and cognition problems



Age minimum: 60 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Diagnostic Test: Respiratory Muscle Strength
Device: Balance Training
Device: Inspiratory Muscle Training
Primary Outcome(s)
Postural Control and Balance [Time Frame: Change from baselines to final evaluation at 8th weeks]
Parkinson's Status- Unified Parkinson's Disease Rating Scale [Time Frame: Change from baselines to final evaluation at 8th weeks]
Respiratory Function- Peak Expiratory Flow [Time Frame: Change from baselines to final evaluation at 8th weeks]
Respiratory Function- Forced Vital Capasity (FVC) [Time Frame: Change from baselines to final evaluation at 8th weeks]
Inspiratory Muscle Strength [Time Frame: Change from baselines to final evaluation at 8th weeks]
Respiratory Function- Forced Expiratory Volume in 1 second [Time Frame: Change from baselines to final evaluation at 8th weeks]
Secondary Outcome(s)
Quality of Life Parameter-Nottingham Health Profile [Time Frame: Change from baselines to final evaluation at 8th weeks]
Activities of Daily Living-Barthel [Time Frame: Change from baselines to final evaluation at 8th weeks]
Mobility Status- Rivermead mobility index [Time Frame: Change from baselines to final evaluation at 8th weeks]
Secondary ID(s)
BezmialemVU27
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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