Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study of Inspiratory Muscle Strength Training and Incentive Spirometer on Ventilatory Function in Postmenopausal Asthmatic Women

Conditions
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Asthmatic, Postmenopausal Symptoms

Intervention / Treatment
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* Device: incentive spirometer
* Other: Inspiratory muscle trainer device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Strength Training<br>in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training) | Other: Inspiratory muscle trainer device<br>* 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.<br>|
| Experimental: Incentive Spirometer<br>incentive spirometer, three sessions per week for six weeks | Device: incentive spirometer<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic Spirometer (VIASYS- Health Care Microlab) | It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L). | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory, Spirometer, Postmenopausal, asthma