AsthmaticNCT05915845
Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient
A study testing Laura Mitchell's Relaxation technique and Papworth exercise in people with Asthmatic, run by Riphah International University at 1 site in Pakistan.
Trial summary
Asthma is a lung disease that is characterized by airway obstruction that is reversible either spontaneously or with treatment, airway inflammation, and increase airway responsiveness to a variety of stimuli. A wide variety of pharmacological interventions are available nowadays. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Asthmatic
- What is being tested?
- Laura Mitchell's Relaxation technique and Papworth exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with the history of acute asthmatic attack in last one month.
- Hemodynamically unstable.
- Cough and active hemoptysis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Laeeque Rafiq Hospital
Lar, Punjab Province, 61000
Ameena Amjad, tDPT, 03234184526
About this study
Official title: Effects of Laura Mitchell's Relaxation Versus Papworth Exercise on Dyspnea, Fatigue, and Sleep Quality in Ashmatic Patient
Asthma is a lung disease that is characterized by airway obstruction that is reversible either spontaneously or with treatment, airway inflammation, and increase airway responsiveness to a variety of stimuli. A wide variety of pharmacological interventions are available nowadays. Apart from that, different Physical therapy techniques increase cardiorespiratory fitness and inspiratory pressure and limit symptoms and restrict medication use. Physical therapy techniques that can be beneficial for an asthmatic patient include Breathing exercises (BE), Inspiratory muscle training (IMT), physical therapy training (PhT), and airway clearance (AC). Laura Mitchell's Relaxation technique and Papworth exercise are advised as an effective nonpharmacological intervention leading to the improvement of symptoms in asthmatic patients. In this study the effects of Laura Mitchell's relaxation technique and Papworth exercise on dyspnea, fatigue, and sleep quality in asthmatic patients will be compared. A randomized clinical trial will be conducted at Laeeque Rafiq Hospital, Lar. Convenient sampling technique will be applied on-patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A \& group B. Group A will be treated with Laura Mitchell's Relaxation technique and Group B will be treated with Papworth exercise. Treatment evaluation will be done after 2 weeks of intervention through Pulse Oximeter, Asthma fatigue scale, Dyspnea 12 scale and Pittsburgh sleep quality index. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Asthmatic
- Being tested
- Laura Mitchell's Relaxation technique, Papworth exercise
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laura Mitchell's Relaxation techniqueOther
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.
Papworth exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laura Mitchell's Relaxation technique | Experimental | Not described Receives: Other: Laura Mitchell's Relaxation technique |
| Papworth exercise | Active comparator | Not described Receives: Other: Papworth exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter
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
Measured: 6 weeks
COPD and Asthma fatigue scale
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
Measured: 6 weeks
Dyspnea 12 scale
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
Measured: 6 weeks
Pittsburgh sleep quality index
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Feb 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AsthmaticStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameena Amjad, tDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915845
- Sponsor's protocol ID
- REC/RCR & AHS/23/0314
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26335830Janson 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.
PubMed 30723731Bruurs 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.
PubMed 23333065Akgun 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.
PubMed 26573455Santino 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.
PubMed 32212422Pourdowlat 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.
PubMed 31282555Climaco 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.
PubMed 35508063Ebadi 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.
PubMed 33853886James 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.
PubMed 32903547Lu 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.
PubMed 31719191Setyowati 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.
PubMed 32632973Shi 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.
PubMed 35971142Yorke 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.
PubMed 20595454Holloway 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.
PubMed 17573445
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laura Mitchell's Relaxation Versus Papworth Exercise on Dyspnea, Fatigue, and Sleep Quality in Ashmatic Patient
- ClinicalTrials.gov ID
- NCT05915845
- Acronym / sponsor ID
- REC/RCR & AHS/23/0314
- Conditions
- Asthmatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a lung disease that is characterized by airway obstruction that is reversible either spontaneously or with treatment, airway inflammation, and increase airway responsiveness to a variety of stimuli. A wide variety of pharmacological interventions are available nowadays. Apart from that, different Physical therapy techniques increase cardiorespiratory fitness and inspiratory pressure and limit symptoms and restrict medication use. Physical therapy techniques that can be beneficial for an asthmatic patient include Breathing exercises (BE), Inspiratory muscle training (IMT), physical therapy training (PhT), and airway clearance (AC). Laura Mitchell's Relaxation technique and Papworth exercise are advised as an effective nonpharmacological intervention leading to the improvement of symptoms in asthmatic patients. In this study the effects of Laura Mitchell's relaxation technique and Papworth exercise on dyspnea, fatigue, and sleep quality in asthmatic patients will be compared. A randomized clinical trial will be conducted at Laeeque Rafiq Hospital, Lar. Convenient sampling technique will be applied on-patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A \& group B. Group A will be treated with Laura Mitchell's Relaxation technique and Group B will be treated with Papworth exercise. Treatment evaluation will be done after 2 weeks of intervention through Pulse Oximeter, Asthma fatigue scale, Dyspnea 12 scale and Pittsburgh sleep quality index. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laura Mitchell's Relaxation technique | Experimental | Other: Laura Mitchell's Relaxation technique |
| Papworth exercise | Active comparator | Other: Papworth exercise |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with the history of acute asthmatic attack in last one month.
- Hemodynamically unstable.
- Cough and active hemoptysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laura Mitchell's Relaxation techniqueThis 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. | Other | Laura Mitchell's Relaxation technique |
| Papworth exerciseThe 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. | Other | Papworth exercise |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 26335830Toskala E, Kennedy DW. Asthma risk factors. Int Forum Allergy Rhinol. 2015 Sep;5 Suppl 1(Suppl 1):S11-6. doi: 10.1002/alr.21557.
- Background: PubMed 30723731Janson 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.
- Background: PubMed 23333065Bruurs 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.
- Background: PubMed 26573455Akgun 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.
- Background: PubMed 32212422Santino 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.
- Background: PubMed 31282555Pourdowlat 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.
- Background: PubMed 35508063Climaco 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.
- Background: PubMed 33853886Ebadi 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.
- Background: PubMed 32903547James 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.
- Background: PubMed 31719191Lu 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.
- Background: PubMed 32632973Setyowati 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.
- Background: PubMed 35971142Shi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameena Amjad, tDPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laura Mitchell's Relaxation technique and Papworth exercise in people with Asthmatic, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915845, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.