NCT06319690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

March 4, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

Breathing exercisesLion's Breath TechniquePulmonary rehabilitation

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental Group (Lion breath)

EXPERIMENTAL

Lion's Breath Technique + Chest Percussion Therapy

Other: Lion's Breath TechniqueOther: Chest Percussion Therapy

Control Group (Routine treatment)

ACTIVE COMPARATOR

Chest Percussion Therapy only

Other: Chest Percussion Therapy

Interventions

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

Experimental Group (Lion breath)

Trained physiotherapists administer chest percussion therapy to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week.

Control Group (Routine treatment)Experimental Group (Lion breath)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Muhammad Faizan Hamid, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 20, 2024

Study Start

March 1, 2024

Primary Completion

June 5, 2024

Study Completion

June 15, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations