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CompletedNCT04267666trainingUpdated Feb 13, 2020

Inspiratory Muscle Strength Training and Incentive Spirometer on Postmenopausal Asthmatic Women

An interventional study of incentive spirometer and Inspiratory muscle trainer device in Asthmatic and Postmenopausal Symptoms, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthmatic
  • Postmenopausal Symptoms

Keywords

  • Inspiratory
  • Spirometer
  • Postmenopausal
  • asthma
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 40 is close to the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • participant who had chest infection,
  • malignant diseases,
  • Patients with chest trauma.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • Experimental
    Incentive Spirometer

    incentive spirometer, three sessions per week for six weeks

    Device: incentive spirometer

Interventions

  • Deviceincentive 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

  • OtherInspiratory 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.

06

What researchers measure

Primary outcomes

  1. Electronic Spirometer (VIASYS- Health Care Microlab)

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

    Time frame: 6 weeks

  2. 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)

    Time frame: 6 weeks

  3. 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)

    Time frame: 6 weeks

  4. 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)

    Time frame: 6 weeks

Secondary outcomes

  1. 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).

    Time frame: 6 weeks

07

Study locations

1 site
  • Ghada Ebrahim Elrefaye
    Giza, Dokki Assistant professor, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04267666
Lead sponsor
Cairo University
Responsible party
Ghada Ebrahim El Refaye (assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Cairo University) — Principal investigator
First posted
Feb 13, 2020
Start date
Jul 1, 2019
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Feb 13, 2020

Study contacts

ghada eb elrefaye, professor
principal investigator · Department of Physical Therapy for Women's Health, Cairo University, Egypt.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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