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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06460597
Other study ID # REC/RCR&AHS/23/0382
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date July 15, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact IQBAL TARIQ, PHD
Phone 03338236752
Email iqbal.tariq@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date July 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Pakistan Gulab Devi Chest Hospital Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse Oximeter oxygen saturation baseline and fourth week
Primary 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
Primary 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
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