NCT06460597

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

asthma,Anxiety,Papworth Technique

Outcome Measures

Primary Outcomes (3)

  • Pulse Oximeter

    oxygen saturation

    baseline and fourth week

  • Hospital Anxiety Depression Scale

    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

    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

Study Arms (2)

Papworth Technique

EXPERIMENTAL

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

Pranayama

ACTIVE COMPARATOR

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

Interventions

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

Papworth Technique

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.

Pranayama

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Chest Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • Sockrider M, Fussner L. What Is Asthma? Am J Respir Crit Care Med. 2020 Nov 1;202(9):P25-P26. doi: 10.1164/rccm.2029P25. No abstract available.

    PMID: 33124914BACKGROUND
  • Gans MD, Gavrilova T. Understanding the immunology of asthma: Pathophysiology, biomarkers, and treatments for asthma endotypes. Paediatr Respir Rev. 2020 Nov;36:118-127. doi: 10.1016/j.prrv.2019.08.002. Epub 2019 Oct 9.

    PMID: 31678040BACKGROUND
  • Miller RL, Grayson MH, Strothman K. Advances in asthma: New understandings of asthma's natural history, risk factors, underlying mechanisms, and clinical management. J Allergy Clin Immunol. 2021 Dec;148(6):1430-1441. doi: 10.1016/j.jaci.2021.10.001. Epub 2021 Oct 14.

    PMID: 34655640BACKGROUND

MeSH Terms

Conditions

AsthmaAnxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental Disorders

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

June 11, 2024

First Posted

June 14, 2024

Study Start

January 15, 2024

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations