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Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women (training)

Primary Purpose

Asthmatic, Postmenopausal Symptoms

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
incentive spirometer
Inspiratory muscle trainer device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthmatic focused on measuring Inspiratory, Spirometer, Postmenopausal, asthma

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Forty postmenopausal women suffering from asthma
  • Their ages were ranged from 50 to 60 years,
  • their body mass index (BMI) don't exceed 30kg/m2.
  • All participants were asthmatic patient
  • clinically and medically stable cases

Exclusion Criteria:

  • participant who had chest infection,
  • malignant diseases,
  • Patients with chest trauma.

Sites / Locations

  • Ghada Ebrahim Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inspiratory Muscle Strength Training

Incentive Spirometer

Arm Description

in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)

incentive spirometer, three sessions per week for six weeks

Outcomes

Primary Outcome Measures

Electronic Spirometer (VIASYS- Health Care Microlab)
It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).
FVC (Forced vital capacity)
is one of the most useful tests to assess the overall ability to move air in and out of the lungs (ventilation). This is the maximum amount of air that can be forcefully and rapidly exhaled after a deep breath (maximal inspiration),reported as a number in liters (L)
FEV1 (Forced expiratory volume)
is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)
MVV (Maximum voluntary ventilation)
is the maximum air, which can be expired in a minute by deepest and fastest breathing, reported as a number in liters (L)

Secondary Outcome Measures

Body mass index
It was used for measuring the weight and height of each patient to calculate the body mass index. BIM=weight (Kg) / height (m2).

Full Information

First Posted
January 31, 2020
Last Updated
February 10, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04267666
Brief Title
Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women
Acronym
training
Official Title
Comparative Study of Inspiratory Muscle Strength Training and Incentive Spirometer on Ventilatory Function in Postmenopausal Asthmatic Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Objective: To compare the effectiveness of inspiratory muscle training (IMT) and incentive spirometer on ventilatory functions in post-menopausal asthmatic women. Participants and methods: A total of forty postmenopausal women suffering from asthma, their ages ranged from 50 to 60 years old, and their body mass index of the patient don't exceed 30kg/m2. They were recruited from patient chest clinic in Kasr -El- Ainy Teaching Hospital, Cairo University, Egypt.
Detailed Description
They signed a consent form, confidentiality was assured. They assigned into two groups (A) who received inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) while patients in group (B): received traditional chest physical therapy intervention and incentive spirometer, three sessions per week for six weeks. Patients in both groups were assessed before treatment (pre-training) then after treatment (post-training) (after 6 weeks) to measure lung functions using electronic spirometer. The training program was carried in the duration from January 2019 to July 2019.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic, Postmenopausal Symptoms
Keywords
Inspiratory, Spirometer, Postmenopausal, asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
inspiratory muscle training in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
Masking
Outcomes Assessor
Masking Description
Participants were assigned randomly used sealed envelope into two groups (A&B) equally in number.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Strength Training
Arm Type
Experimental
Arm Description
in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
Arm Title
Incentive Spirometer
Arm Type
Experimental
Arm Description
incentive spirometer, three sessions per week for six weeks
Intervention Type
Device
Intervention Name(s)
incentive spirometer
Intervention Description
Patient had to produce a high inspiratory pressure. The ball serves as visible feedback of the inspiratory flow and indicates the obtained flow on a calibrated scale on the transparent cylinder of the spirometer. If the patient flows greater than 300 milliliters per second, the float ball in first chamber will rise. As patient flow increases to 600 milliliters per second the second ball float will rise. If the patient flow exceeds 900 milliliters per second all three will be suspended. Patient should encourage holding the balls up for a few seconds
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle trainer device
Intervention Description
The threshold trainer is a small plastic handheld device supplied by respironics. It includes a mouthpiece and a calibrated spring loaded valve. The valve controls a constant inspiratory pressure training load and the patient must generate the inspiratory pressure in order for the inspiratory valve to be opened and allow inhalation of air.
Primary Outcome Measure Information:
Title
Electronic Spirometer (VIASYS- Health Care Microlab)
Description
It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).
Time Frame
6 weeks
Title
FVC (Forced vital capacity)
Description
is one of the most useful tests to assess the overall ability to move air in and out of the lungs (ventilation). This is the maximum amount of air that can be forcefully and rapidly exhaled after a deep breath (maximal inspiration),reported as a number in liters (L)
Time Frame
6 weeks
Title
FEV1 (Forced expiratory volume)
Description
is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)
Time Frame
6 weeks
Title
MVV (Maximum voluntary ventilation)
Description
is the maximum air, which can be expired in a minute by deepest and fastest breathing, reported as a number in liters (L)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body mass index
Description
It was used for measuring the weight and height of each patient to calculate the body mass index. BIM=weight (Kg) / height (m2).
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Forty postmenopausal women suffering from asthma Their ages were ranged from 50 to 60 years, their body mass index (BMI) don't exceed 30kg/m2. All participants were asthmatic patient clinically and medically stable cases Exclusion Criteria: participant who had chest infection, malignant diseases, Patients with chest trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
Department of Physical Therapy for Women's Health, Cairo University, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghada Ebrahim Elrefaye
City
Giza
State/Province
Dokki
ZIP/Postal Code
Assistant professor
Country
Egypt

12. IPD Sharing Statement

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Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

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