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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05201742
Other study ID # GSITESC/24/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2017
Est. completion date May 10, 2018

Study information

Verified date January 2022
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients suffering from parkinsonism have respiratory function abnormalities. This study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.


Description:

The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 10, 2018
Est. primary completion date January 18, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria: - Patients diagnosed as having Parkinsonism Disease by the Neuro physician. - Duration of Parkinson's Disease = 5 years. - Patients with the age of 65 to 80 years. - Hoen and Yahr classification within 1 to 3. - Both males and females were included. - Patients who were able to comprehend the commands. - Patients who were willing to participate. Exclusion Criteria: - Patients having any cardiovascular and pulmonary disorders. - History of smoking currently or in the past. - Psychological Impairment. - Insufficient verbal/intellectual understanding. - Patients with unstable vital parameters. - Those unable to perform pulmonary function tests (PFT) because of anatomical abnormalities or clinical signs of dementia.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory muscle training
Threshold inspiratory muscle training was performed for 6 weeks with device.
Incentive Spirometry
Incentive spirometry was performed for 6 weeks with device.

Locations

Country Name City State
Saudi Arabia King Saud University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum inspiratory pressure (MIP) Maximum inspiratory pressure was measured. 6 weeks
Primary 6-minute walk distance (6 MWD) Distance walked by the patients in 6 minutes was measured. 6 weeks
Primary Forced vital capacity (FVC) Forced vital capacity was measured. 6 weeks
Primary Forced expiratory volume in 1 second (FEV1) Forced expiratory volume in 1 second was measured 6 weeks
Primary Peak Expiratory Flow Rate (PEFR) Peak Expiratory Flow Rate was measured 6 weeks
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