Comparison of Flutter and PEP Mask on Chest Clearance, Dyspnea in Elderly Asthmatic Patients

NCT05618873 | Unknown

• 1 other identifier: REC/ ALI HASSAN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.

Conditions

Asthma

Keywords

Flutter; PEP Mask; Chest Clearance; Dyspnea

Outcome Measures

Primary Outcomes (3)

• ST. GEORGE'S RESPIRATORY QUESTINAIR

  The SGRQ is designed to measure health impairment in patients with asthma and COPD. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations.

  2weeks

• PULMONARY FUNCTION TEST

  Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. The most basic test is spirometry. Spirometry is used to screen for diseases that affect lung volumes. It also is used to screen for diseases that affect the airways, such as COPD or asthma.

  2weeeks

• SPUTUM DIARY

  The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms)

  2weeks

Study Arms (2)

flutter device therapy

EXPERIMENTAL

The flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees.

Device: Flutter device

Positive Expiratory Pressure Mask

EXPERIMENTAL

The PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask. Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times.

Device: positive expiratory pressure mask

Interventions

Flutter device DEVICE

The flutter was used as follows. Sitting with a straight back and the elbows supported on the table, the patient held the flutter horizontally. The patient inhaled deeply, held their breath for 2 or 3 s and then took the mouthpiece into the mouth and exhaled quietly yet quickly enough to activate the flutter. The patient had to keep their cheeks as stiff as possible. This procedure was repeated 15 times, following which the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times. The patient obtained the maximal vibration sensation by tilting the flutter upwards or downwards by a few degrees.

flutter device therapy

positive expiratory pressure mask DEVICE

The PEP-mask was used as follows. Sitting with a straight back and the elbows supported on the table, the patient pressed the mask against the face with both hands. After a quiet inhalation, a slow active exhalation followed. The exhalation was restricted by a resistance selected to cause a positive expiratory pressure of 8-12 cmH2O. The patient exhaled 15 times through the mask. Thereafter, the patient huffed three times and evacuated sputum by a voluntary cough. This sequence was repeated five times.

Positive Expiratory Pressure Mask

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical Diagnosis Of Asthma
• Both age above 40-60 years of age
• Both gender
• No previous surgery

You may not qualify if:

• Other pulmonary disease
• Neurological problems
• Rib fracture

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allied hospital

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Asthma; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Madiha younas, MS

  riphah internationl university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran amjad, PHD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)