Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

Postmenopausal Symptoms Clinical Trial

— training  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267666
• Other study ID #: CairoU9
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthmatic
• Postmenopausal Symptoms
• Respiratory Aspiration

Intervention

Device:
• incentive spirometer
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

Other:
• Inspiratory muscle trainer device
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.

Locations

Country	Name	City	State
Egypt	Ghada Ebrahim Elrefaye	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronic Spirometer (VIASYS- Health Care Microlab)	It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).	6 weeks
Primary	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
Primary	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
Primary	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	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