Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

Not Applicable

Completed

• Conditions: Postmenopausal Symptoms; Asthmatic
• Interventions: Other: Inspiratory muscle trainer device; Device: incentive spirometer

• Registration Number: NCT04267666
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Study First Submitted: 2020-01-31
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Strength Training	Inspiratory muscle trainer device	in the form of: Inspiratory threshold muscle trainer in addition to traditional chest physical therapy intervention (Deep breath, cough training)
Incentive Spirometer	incentive spirometer	incentive spirometer, three sessions per week for six weeks

Primary Outcome Measures

Name	Time	Method
MVV (Maximum voluntary ventilation)	6 weeks	is the maximum air, which can be expired in a minute by deepest and fastest breathing, reported as a number in liters (L)
Electronic Spirometer (VIASYS- Health Care Microlab)	6 weeks	It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).
FVC (Forced vital capacity)	6 weeks	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)	6 weeks	is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)

Secondary Outcome Measures

Name	Time	Method
Body mass index	6 weeks	It was used for measuring the weight and height of each patient to calculate the body mass index. BIM=weight (Kg) / height (m2).

Trial Locations

Locations (1)

Ghada Ebrahim Elrefaye; 🇪🇬 Giza, Dokki, Egypt