Incentive Spirometer and Inspiratory Muscle Trainer

Sponsor

King Saud University (Other)

Overall Status

Completed

CT.gov ID

NCT05201742

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Inspiratory muscle training Other: Incentive Spirometry	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism

Actual Study Start Date :

Feb 6, 2017

Actual Primary Completion Date :

Jan 18, 2018

Actual Study Completion Date :

May 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inspiratory muscle trainer Inspiratory muscle trainer group - Inspiratory muscle training was performed.	Other: Inspiratory muscle training Threshold inspiratory muscle training was performed for 6 weeks with device.
Active Comparator: Incentive spirometer Incentive spirometer group - Incentive spirometry was performed.	Other: Incentive Spirometry Incentive spirometry was performed for 6 weeks with device.

Arm

Intervention/Treatment

Active Comparator: Inspiratory muscle trainer

Inspiratory muscle trainer group - Inspiratory muscle training was performed.

Other: Inspiratory muscle training

Threshold inspiratory muscle training was performed for 6 weeks with device.

Active Comparator: Incentive spirometer

Incentive spirometer group - Incentive spirometry was performed.

Other: Incentive Spirometry

Incentive spirometry was performed for 6 weeks with device.

Outcome Measures

Primary Outcome Measures

Maximum inspiratory pressure (MIP) [6 weeks]
Maximum inspiratory pressure was measured.
6-minute walk distance (6 MWD) [6 weeks]
Distance walked by the patients in 6 minutes was measured.
Forced vital capacity (FVC) [6 weeks]
Forced vital capacity was measured.
Forced expiratory volume in 1 second (FEV1) [6 weeks]
Forced expiratory volume in 1 second was measured
Peak Expiratory Flow Rate (PEFR) [6 weeks]
Peak Expiratory Flow Rate was measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.