Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

NCT ID: NCT04267666

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-30

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.

Conditions

Asthmatic; Postmenopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inspiratory Muscle Strength Training

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

Group Type: EXPERIMENTAL

Inspiratory muscle trainer device

Intervention Type: OTHER

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.

Incentive Spirometer

incentive spirometer, three sessions per week for six weeks

Group Type: EXPERIMENTAL

incentive spirometer

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Ebrahim El Refaye

assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy for Women's Health, Cairo University, Egypt.

Locations

Ghada Ebrahim Elrefaye

Giza, Dokki, Egypt

Countries

Egypt

Other Identifiers

CairoU9

Identifier Type: -

Identifier Source: org_study_id