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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06319690
Other study ID # REC/RCR&AHS/23/0362
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date June 15, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.


Description:

The main objective of the study is to determine the effect of lion's breath technique along with chest percussion therapy in pneumonia patients. This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Participants included will be adults aged 18 years and above diagnosed with pneumonia. Willing to comply with the study protocol. Both male and female will be included. Participants should be in stable health conditions to participate in the Study. Patients with severe or life-threatening pneumonia requiring immediate intensive care and patients with physical or cognitive limitations. Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma. Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions and Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area will be excluded. Group A (Lion's Breath Technique + Chest Percussion Therapy) Daily supervised Lion's Breath Technique sessions will be for 20 minutes for 1 week. Trained physiotherapists administer chest percussion therapy will be to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week. Pre and post data will be gathered. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 15, 2024
Est. primary completion date June 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients in the post-acute phase of pneumonia recovery. - Adults aged 18 years and above diagnosed with pneumonia. - Both male and female will be included. - Participants should be in stable health conditions to participate in the Study. - Willing to comply with the study protocol Exclusion Criteria: - Patients with severe or life-threatening pneumonia requiring immediate intensive care - Patients with physical or cognitive limitations - Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma - Pregnant or breastfeeding women - Individuals with musculoskeletal or neurological conditions - Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lion's Breath Technique
Patients receive training in Lion's Breath Technique, emphasizing deep diaphragmatic breathing and controlled exhalation. Daily supervised Lion's Breath Technique sessions for 20 minutes for 1 week
Chest Percussion Therapy
Trained physiotherapists administer chest percussion therapy to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week.

Locations

Country Name City State
Pakistan Jinnah Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary George respiratory questionnaire The George respiratory questionnaire is Disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total 50 items, 2 parts (3 components). Part 1 : Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
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.
1 Week
Primary Forced vital capacity (FVC) Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry 1 Week
Primary Borg Dyspnea Scale The borg dyspnea scale is a numerical scale that measures the intensity of breathlessness of fatigue. It will be used to assess the baseline and posttest symptoms of patients with respiratory and cardiac condition.
This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal
1 Week
Primary Forced expiratory volume (FEV1) Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. it is measured using Spirometer. 1 Week
Primary FEV1/FVC Ratio The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, measured using Spirometer. 1 Week
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