- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915845
Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient
Effects of Laura Mitchell's Relaxation Versus Papworth Exercise on Dyspnea, Fatigue, and Sleep Quality in Ashmatic Patient
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lar, Punjab, Pakistan, 61000
- Recruiting
- Laeeque Rafiq Hospital
-
Contact:
- Ameena Amjad, tDPT
- Phone Number: 03234184526
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group of 20-45 years
- Both male and females
- patients diagnosed with asthma according to GINA guidelines, who had not smoked for at least one year
Exclusion Criteria:
- Patients with the history of acute asthmatic attack in last one month.
- Hemodynamically unstable.
- Cough and active hemoptysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laura Mitchell's Relaxation technique
|
This technique was used to eliminate muscular tension.
Patients were taught to contract muscles opposite to the strained muscle groups, eventually to 'cease' shrunken them, and then to roster the position adaptation of the body structure.
Patient was comfortably positioned.
|
Active Comparator: Papworth exercise
|
The Papworth Method integrates five components, the principal one being specific breathing training: • Breathing training, including teaching of appropriate minute and tidal volume and the development of a pattern of breathing suitable to current metabolic activity. Elimination of dysfunctional breathing, including hyperinflation and hyperventilation patterns is discussed. A specific Papworth method diaphragmatic breathing technique is taught to replace the use of inappropriate accessory muscles of respiration. When relaxed, is placed on calm slow nasal expiration. Patients are encouraged to "nose-breathe" rather than "mouth-breathe" and eradication or reduction of habits such as yawning, sighing, etc. is taught and practiced. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulse Oximeter
Time Frame: 6 weeks
|
Pulse oximetry, measuring SpO2 as a proxy for SaO2 using a non-invasive and simple device, is frequently used to detect low blood oxygen levels.
Pulse oximetry has been widely used in non-clinical settings, to detect hypoxemia and inform decisions to escalate care
|
6 weeks
|
COPD and Asthma fatigue scale
Time Frame: 6 weeks
|
The 21-item COPD and Asthma fatigue scale incorporated items on fatigue associated with respiratory disease and breathing problems.
The response options were 1 = never to 5 = very often.
COPD and Asthma fatigue scale raw scores were linearly transformed to a 0-100 total scale score, with higher scores indicating greater fatigue
|
6 weeks
|
Dyspnea 12 scale
Time Frame: 6 weeks
|
D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3).
It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items
|
6 weeks
|
Pittsburgh sleep quality index
Time Frame: 6 weeks
|
Pittsburgh sleep quality index (PSQI) is an effective instrument used to measure the quality and pattern of sleep.
The PSQI was originally designed for use in clinical populations as a simple and valid assessment of both sleep quality and disturbance that might affect sleep quality
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ameena Amjad, tDPT, Riphah International University
Publications and helpful links
General Publications
- Lu Y, Li P, Li N, Wang Z, Li J, Liu X, Wu W. Effects of Home-Based Breathing Exercises in Subjects With COPD. Respir Care. 2020 Mar;65(3):377-387. doi: 10.4187/respcare.07121. Epub 2019 Nov 12.
- Holloway EA, West RJ. Integrated breathing and relaxation training (the Papworth method) for adults with asthma in primary care: a randomised controlled trial. Thorax. 2007 Dec;62(12):1039-42. doi: 10.1136/thx.2006.076430. Epub 2007 Jun 15.
- Bruurs ML, van der Giessen LJ, Moed H. The effectiveness of physiotherapy in patients with asthma: a systematic review of the literature. Respir Med. 2013 Apr;107(4):483-94. doi: 10.1016/j.rmed.2012.12.017. Epub 2013 Jan 18.
- Santino TA, Chaves GS, Freitas DA, Fregonezi GA, Mendonca KM. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD001277. doi: 10.1002/14651858.CD001277.pub4.
- Toskala E, Kennedy DW. Asthma risk factors. Int Forum Allergy Rhinol. 2015 Sep;5 Suppl 1(Suppl 1):S11-6. doi: 10.1002/alr.21557.
- Janson C, Accordini S, Cazzoletti L, Cerveri I, Chanoine S, Corsico A, Ferreira DS, Garcia-Aymerich J, Gislason D, Nielsen R, Johannessen A, Jogi R, Malinovschi A, Martinez-Moratalla Rovira J, Marcon A, Pin I, Quint J, Siroux V, Almar E, Bellisario V, Franklin KA, Gullon JA, Holm M, Heinrich J, Nowak D, Sanchez-Ramos JL, Weyler JJ, Jarvis D. Pharmacological treatment of asthma in a cohort of adults during a 20-year period: results from the European Community Respiratory Health Survey I, II and III. ERJ Open Res. 2019 Feb 1;5(1):00073-2018. doi: 10.1183/23120541.00073-2018. eCollection 2019 Feb.
- Akgun Sahin Z, Dayapoglu N. Effect of progressive relaxation exercises on fatigue and sleep quality in patients with chronic obstructive lung disease (COPD). Complement Ther Clin Pract. 2015 Nov;21(4):277-81. doi: 10.1016/j.ctcp.2015.10.002. Epub 2015 Oct 19. Erratum In: Complement Ther Clin Pract. 2018 May;31:389.
- Pourdowlat G, Hejrati R, Lookzadeh S. The effectiveness of relaxation training in the quality of life and anxiety of patients with asthma. Adv Respir Med. 2019;87(3):146-151. doi: 10.5603/ARM.2019.0024.
- Climaco DCS, Lustosa TC, Silva MVFP, Lins-Filho OL, Rodrigues VK, Oliveira-Neto LAP, Feitosa ADM, Queiroga FJP Jr, Cabral MM, Pedrosa RP. Sleep quality in COPD patients: correlation with disease severity and health status. J Bras Pneumol. 2022 Apr 29;48(3):e20210340. doi: 10.36416/1806-3756/e20210340. eCollection 2022.
- Ebadi Z, Goertz YMJ, Van Herck M, Janssen DJA, Spruit MA, Burtin C, Thong MSY, Muris J, Otker J, Looijmans M, Vlasblom C, Bastiaansen J, Prins J, Wouters EFM, Vercoulen JH, Peters JB. The prevalence and related factors of fatigue in patients with COPD: a systematic review. Eur Respir Rev. 2021 Apr 13;30(160):200298. doi: 10.1183/16000617.0298-2020. Print 2021 Jun 30.
- James MD, Milne KM, Phillips DB, Neder JA, O'Donnell DE. Dyspnea and Exercise Limitation in Mild COPD: The Value of CPET. Front Med (Lausanne). 2020 Aug 13;7:442. doi: 10.3389/fmed.2020.00442. eCollection 2020.
- Setyowati A, Chung MH. Validity and reliability of the Indonesian version of the Pittsburgh Sleep Quality Index in adolescents. Int J Nurs Pract. 2021 Oct;27(5):e12856. doi: 10.1111/ijn.12856. Epub 2020 Jul 7.
- Shi C, Goodall M, Dumville J, Hill J, Norman G, Hamer O, Clegg A, Watkins CL, Georgiou G, Hodkinson A, Lightbody CE, Dark P, Cullum N. The accuracy of pulse oximetry in measuring oxygen saturation by levels of skin pigmentation: a systematic review and meta-analysis. BMC Med. 2022 Aug 16;20(1):267. doi: 10.1186/s12916-022-02452-8.
- Yorke J, Swigris J, Russell AM, Moosavi SH, Ng Man Kwong G, Longshaw M, Jones PW. Dyspnea-12 is a valid and reliable measure of breathlessness in patients with interstitial lung disease. Chest. 2011 Jan;139(1):159-64. doi: 10.1378/chest.10-0693. Epub 2010 Jul 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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