Comparative Effects of Papworth Technique Versus Pranayama in Asthmatic Patients

July 22, 2024 updated by: Riphah International University

Asthma is a chronic and heterogeneous disease characterized by reversible airway obstruction, airway inflammation and bronchial damage causing dyspnea, wheezing, chest tightness, coughing and impaired quality of life. Papworth technique and Pranayama modify the pattern of breathing to reduce the hyperventilation resulting in normalization of CO2 levels, reduction of bronchospasm and resulting breathlessness

.These techniques also change the emotional stresses, improve the immunity system and improve the strength /endurance of respiratory muscles. After taking the consent form from the participants, data will be collected from Gulab Devi Chest Hospital. Non-Probability Convenience Sampling will be applied on asthmatic patients according to inclusion criteria. Patients will be allocated through simple random sampling into group A and B to collect data. Group A will be treated by Papworth technique. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Group B will be treated by Pranayama. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Papworth Technique and Pranayama are used and are assessed to see their effectiveness in asthmatic patients by using four questionnaires on dyspnea, fatigue, anxiety, depression and quality of life. These four standardized questionnaires are Borg Dyspnea Scale (BDS), Modified Fatigue Impact Scale (MFIS), Hospital Anxiety Depression Scale (HADS) and Asthma Quality of life. Pulse oximeter will be used to check the oxygen saturation. The study duration will be completed within time duration of 7 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Gulab Devi Chest Hospital Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both genders(male and female)
  • Age 20-40 years
  • Patients with adverse mood effects
  • Mild to moderate chronic asthma

Exclusion Criteria:

  • Acute severe asthma
  • Chronic chest infections like TB
  • Chest deformity
  • Bronchiectasis
  • Cardiac Disease
  • Substance abusers
  • Chronic Obstructive Pulmonary Disease
  • Neurological Disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Papworth Technique
The Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times
Other: Papworth Technique
The Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times
Active Comparator: Pranayama
Pranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced.
Other: Pranayama
Pranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulse Oximeter
Time Frame: baseline and fourth week
oxygen saturation
baseline and fourth week
Hospital Anxiety Depression Scale
Time Frame: baseline and fourth week
It is a self- assessment scale. It is a reliable instrument for detecting the anxiety and depression in patients with asthma. The anxiety and depressive subscales are also valid measures of severity of emotional stresses. The HADS is a self-report rating scale consists of 14 items on a 4 point Likert Scale range from 0-3.It measures anxiety and depression, 7 items for each subscale. The total score is the sum of 14 items and for each subscale is the sum of respective seven items, ranging from 0-21
baseline and fourth week
Asthma Quality of life
Time Frame: baseline and fourth week
It has 32 questions that contains four sub domains, these are symptoms 11 items, activity limitations 12, emotional function 5, environmental stimuli 4 items. This is marked on a 7 point Likert scale that is changing from 1 to 7 where higher scores indicate better quality of life,1 indicates severely impaired patients with asthma while 7 indicates no impairments. Asthma quality of life has strong measurement properties and is valid for measuring health related quality of life in asthma.
baseline and fourth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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