Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

NCT04267666 | Completed

• 1 other identifier: CairoU9
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthmatic; Postmenopausal Symptoms

Keywords

Inspiratory; Spirometer; Postmenopausal; asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Body mass index

  6 weeks

Study Arms (2)

Inspiratory Muscle Strength Training

EXPERIMENTAL

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

Incentive Spirometer

EXPERIMENTAL

incentive spirometer, three sessions per week for six weeks

Device: incentive spirometer

Interventions

incentive spirometer 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

Incentive Spirometer

Inspiratory muscle trainer device 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.

Inspiratory Muscle Strength Training

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• participant who had chest infection,
• malignant diseases,
• Patients with chest trauma.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ghada Ebrahim Elrefaye

Giza, Dokki, Assistant professor, Egypt

Location

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ghada eb elrefaye, professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants were assigned randomly used sealed envelope into two groups (A\&B) equally in number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

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

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 13, 2020
• Study Start: July 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

EG (1)