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Incentive Spirometer and Inspiratory Muscle Trainer

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Inspiratory muscle training
Incentive Spirometry
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Incentive spirometer, Inspiratory muscle trainer, Pulmonary functions

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inspiratory muscle trainer

Incentive spirometer

Arm Description

Inspiratory muscle trainer group - Inspiratory muscle training was performed.

Incentive spirometer group - Incentive spirometry was performed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 9, 2022
Last Updated
January 27, 2022
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05201742
Brief Title
Incentive Spirometer and Inspiratory Muscle Trainer
Official Title
A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Incentive spirometer, Inspiratory muscle trainer, Pulmonary functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle trainer
Arm Type
Active Comparator
Arm Description
Inspiratory muscle trainer group - Inspiratory muscle training was performed.
Arm Title
Incentive spirometer
Arm Type
Active Comparator
Arm Description
Incentive spirometer group - Incentive spirometry was performed.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Threshold inspiratory muscle training was performed for 6 weeks with device.
Intervention Type
Other
Intervention Name(s)
Incentive Spirometry
Intervention Description
Incentive spirometry was performed for 6 weeks with device.
Primary Outcome Measure Information:
Title
Maximum inspiratory pressure (MIP)
Description
Maximum inspiratory pressure was measured.
Time Frame
6 weeks
Title
6-minute walk distance (6 MWD)
Description
Distance walked by the patients in 6 minutes was measured.
Time Frame
6 weeks
Title
Forced vital capacity (FVC)
Description
Forced vital capacity was measured.
Time Frame
6 weeks
Title
Forced expiratory volume in 1 second (FEV1)
Description
Forced expiratory volume in 1 second was measured
Time Frame
6 weeks
Title
Peak Expiratory Flow Rate (PEFR)
Description
Peak Expiratory Flow Rate was measured
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, M.P.Th
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Incentive Spirometer and Inspiratory Muscle Trainer

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