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Completed

NCT Number: NCT04267666

Inspiratory Muscle Strength Training and Incentive Spirometer on 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.

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Key information

Conditions

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

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Ebrahim Elrefaye

Giza, Dokki, Assistant professor, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Electronic Spirometer (VIASYS- Health Care Microlab)

    Time frame: 6 weeks

    It was used for ventilatory functions measurement Ventilatory,reported as a number in liters (L).

  2. FVC (Forced vital capacity)

    Time frame: 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)

  3. FEV1 (Forced expiratory volume)

    Time frame: 6 weeks

    is the volume of air forcibly exhaled in one second during the FVC test,reported as a number in liters (L)

  4. MVV (Maximum voluntary ventilation)

    Time frame: 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)

Secondary outcomes

  1. Body mass index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: training

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2020
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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