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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Symptoms; Asthmatic
• Intervention / Treatment: Other: Inspiratory muscle trainer device; Device: incentive spirometer

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, Assistant professor
      • Ghada Ebrahim Elrefaye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Inspiratory Muscle Strength Training; 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; 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.
EXPERIMENTAL: Incentive Spirometer; incentive spirometer, three sessions per week for six weeks	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ghada eb elrefaye, professor, Department of Physical Therapy for Women's Health, Cairo University, Egypt.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: asthma; Postmenopausal; Spirometer; Inspiratory
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: CairoU9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No