Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients
Primary Purpose
Asthma
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Diaphragm strengthening and accessory muscles stretchings
Diaphragm strengthening
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria: Age group of 40-65 years Both male and females Phase-2 asthma patients Patients hemodynamically stable Exclusion Criteria: Patients having pulmonary tumors Patients of Having cough and sputum Patients having TB and emphysema Patients with pneumonia, pneumonectomy or other lungs surgical procedures
Sites / Locations
- Gulab Devi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diaphragm strengthening and accessory muscles stretchings
Diaphragm strengthening
Arm Description
Outcomes
Primary Outcome Measures
Modified Borg scale of exertion
The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT)
6 MWT
The 6MWT was used to detect participants' functional capacity by measuring the distance they traveled during the walk test. For the 6MWT assessment, the participants were encouraged to walk as far as they could during 6 min over a flat 100-feet surface, and for consistency, the researchers used constant verbal cues and positive feedback to encourage the participants to complete the task
Secondary Outcome Measures
Quality of life questionnaire
HRQOL is one of several variables commonly studied in the field of medical outcomes research. It encompasses a wide range of human experience, including functioning and subjective responses to illness. Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes.
To make useful inferences regarding absolute scores or change scores over time, it is important to determine what meaning different numerical values have. When no such thresholds have been established, one can roughly approximate the smallest difference that is important to the patient as one-third to one-half of a standard deviation
Full Information
NCT ID
NCT05915793
First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05915793
Brief Title
Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients
Official Title
Combined Effects of Diaphragm Strengthening and Accessory Muscles Stretchings in Asthma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 29, 2023 (Anticipated)
Study Completion Date
August 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Asthma is a multifactorial and chronic inflammatory disease in older patients affecting many people worldwide with high cost of pharmacological treatment and physiotherapy interventions. It is characterized by a variety of symptoms including airway inflammation, bronchial hyper-responsiveness, and transient and reversible airway obstruction. Typical clinical features include wheezing, coughing, resting and/or exertional dyspnea, and chest tightness. Lung hyperinflation affects ability to inspire and increases the work of breathing.
Long and short acting corticosteroids and leukotriene are considered effective pharmacological interventions while inspiratory muscle training, incentive spirometry, purse lip breathing, and diaphragm strengthening are considered effective physiotherapy interventions for asthma patients. To find the combined effects of diaphragm strengthening and accessory muscle stretching on chest expansion, pulmonary function, dyspnea and exercise capacity in asthmatic patients. A randomized controlled trial will be conducted at Gulab Davi teaching Hospital Lahore through convenient sampling technique on 40 patients which will be allocated through concealed opaque envelop into Group A and Group Pretreatment values of pulmonary function and chest expansion will be recorded. And patient's perception of exertion through Modified Borg's rating of perceived exertion (RPE) and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with diaphragm strengthening and Group B will be treated with diaphragm strengthening and accessory muscles stretching. Treatment evaluation will be done after 4 weeks. 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 use within a group or between two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diaphragm strengthening and accessory muscles stretchings
Arm Type
Experimental
Arm Title
Diaphragm strengthening
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Diaphragm strengthening and accessory muscles stretchings
Intervention Description
Diaphragm strengthening and accessory muscles stretchings
Intervention Type
Other
Intervention Name(s)
Diaphragm strengthening
Intervention Description
Diaphragm strengthening
Primary Outcome Measure Information:
Title
Modified Borg scale of exertion
Description
The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT)
Time Frame
6 weeks
Title
6 MWT
Description
The 6MWT was used to detect participants' functional capacity by measuring the distance they traveled during the walk test. For the 6MWT assessment, the participants were encouraged to walk as far as they could during 6 min over a flat 100-feet surface, and for consistency, the researchers used constant verbal cues and positive feedback to encourage the participants to complete the task
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
HRQOL is one of several variables commonly studied in the field of medical outcomes research. It encompasses a wide range of human experience, including functioning and subjective responses to illness. Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes.
To make useful inferences regarding absolute scores or change scores over time, it is important to determine what meaning different numerical values have. When no such thresholds have been established, one can roughly approximate the smallest difference that is important to the patient as one-third to one-half of a standard deviation
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age group of 40-65 years
Both male and females
Phase-2 asthma patients
Patients hemodynamically stable
Exclusion Criteria:
Patients having pulmonary tumors
Patients of Having cough and sputum
Patients having TB and emphysema
Patients with pneumonia, pneumonectomy or other lungs surgical procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ameena Amjad, tDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulab Devi Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameena Amjad, tDPT
Phone
03234184526
Email
ameena.uhs@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21876968
Citation
Gomieiro LT, Nascimento A, Tanno LK, Agondi R, Kalil J, Giavina-Bianchi P. Respiratory exercise program for elderly individuals with asthma. Clinics (Sao Paulo). 2011;66(7):1163-9. doi: 10.1590/s1807-59322011000700007.
Results Reference
background
PubMed Identifier
9643741
Citation
Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
Results Reference
background
PubMed Identifier
14635557
Citation
Bradshaw D, Groenewald P, Laubscher R, Nannan N, Nojilana B, Norman R, Pieterse D, Schneider M, Bourne DE, Timaeus IM, Dorrington R, Johnson L. Initial burden of disease estimates for South Africa, 2000. S Afr Med J. 2003 Sep;93(9):682-8.
Results Reference
background
PubMed Identifier
28822787
Citation
GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16. Erratum In: Lancet Respir Med. 2017 Oct;5(10 ):e30.
Results Reference
background
PubMed Identifier
25299857
Citation
Asher I, Pearce N. Global burden of asthma among children. Int J Tuberc Lung Dis. 2014 Nov;18(11):1269-78. doi: 10.5588/ijtld.14.0170.
Results Reference
background
PubMed Identifier
25519785
Citation
Burney P, Jarvis D, Perez-Padilla R. The global burden of chronic respiratory disease in adults. Int J Tuberc Lung Dis. 2015 Jan;19(1):10-20. doi: 10.5588/ijtld.14.0446.
Results Reference
background
PubMed Identifier
19191144
Citation
Hasnain SM, Khan M, Saleem A, Waqar MA. Prevalence of asthma and allergic rhinitis among school children of Karachi, Pakistan, 2007. J Asthma. 2009 Feb;46(1):86-90. doi: 10.1080/02770900802513023.
Results Reference
background
PubMed Identifier
3353893
Citation
Arm JP, Horton CE, Mencia-Huerta JM, House F, Eiser NM, Clark TJ, Spur BW, Lee TH. Effect of dietary supplementation with fish oil lipids on mild asthma. Thorax. 1988 Feb;43(2):84-92. doi: 10.1136/thx.43.2.84.
Results Reference
background
PubMed Identifier
8993724
Citation
Weiler JM. Exercise-induced asthma: a practical guide to definitions, diagnosis, prevalence, and treatment. Allergy Asthma Proc. 1996 Nov-Dec;17(6):315-25. doi: 10.2500/108854196778606437.
Results Reference
background
PubMed Identifier
10906907
Citation
Boulet LP, Becker A, Berube D, Beveridge R, Ernst P. Canadian Asthma Consensus Report, 1999. Canadian Asthma Consensus Group. CMAJ. 1999 Nov 30;161(11 Suppl):S1-61.
Results Reference
background
PubMed Identifier
18982161
Citation
Barnes PJ. The cytokine network in asthma and chronic obstructive pulmonary disease. J Clin Invest. 2008 Nov;118(11):3546-56. doi: 10.1172/JCI36130.
Results Reference
background
PubMed Identifier
18274560
Citation
Barnes PJ. Immunology of asthma and chronic obstructive pulmonary disease. Nat Rev Immunol. 2008 Mar;8(3):183-92. doi: 10.1038/nri2254. Epub 2008 Feb 15.
Results Reference
background
PubMed Identifier
17321575
Citation
Hallstrand TS, Debley JS, Farin FM, Henderson WR Jr. Role of MUC5AC in the pathogenesis of exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2007 May;119(5):1092-8. doi: 10.1016/j.jaci.2007.01.005. Epub 2007 Feb 26. Erratum In: J Allergy Clin Immunol. 2007 Nov;120(5):1102.
Results Reference
background
PubMed Identifier
7480127
Citation
Reid WD, Dechman G. Considerations when testing and training the respiratory muscles. Phys Ther. 1995 Nov;75(11):971-82. doi: 10.1093/ptj/75.11.971.
Results Reference
background
PubMed Identifier
19910609
Citation
Deesomchok A, Fisher T, Webb KA, Ora J, Lam YM, Lougheed MD, O'Donnell DE. Effects of obesity on perceptual and mechanical responses to bronchoconstriction in asthma. Am J Respir Crit Care Med. 2010 Jan 15;181(2):125-33. doi: 10.1164/rccm.200906-0934OC. Epub 2009 Nov 12.
Results Reference
background
PubMed Identifier
22765281
Citation
Illi SK, Held U, Frank I, Spengler CM. Effect of respiratory muscle training on exercise performance in healthy individuals: a systematic review and meta-analysis. Sports Med. 2012 Aug 1;42(8):707-24. doi: 10.1007/BF03262290.
Results Reference
background
PubMed Identifier
21502887
Citation
Turner LA, Mickleborough TD, McConnell AK, Stager JM, Tecklenburg-Lund S, Lindley MR. Effect of inspiratory muscle training on exercise tolerance in asthmatic individuals. Med Sci Sports Exerc. 2011 Nov;43(11):2031-8. doi: 10.1249/MSS.0b013e31821f4090.
Results Reference
background
PubMed Identifier
11083702
Citation
Hallstrand TS, Bates PW, Schoene RB. Aerobic conditioning in mild asthma decreases the hyperpnea of exercise and improves exercise and ventilatory capacity. Chest. 2000 Nov;118(5):1460-9. doi: 10.1378/chest.118.5.1460.
Results Reference
background
PubMed Identifier
15867847
Citation
Lucas SR, Platts-Mills TA. Physical activity and exercise in asthma: relevance to etiology and treatment. J Allergy Clin Immunol. 2005 May;115(5):928-34. doi: 10.1016/j.jaci.2005.01.033. Erratum In: J Allergy Clin Immunol. 2005 Aug;116(2):298.
Results Reference
background
PubMed Identifier
22863207
Citation
Boyd A, Yang CT, Estell K, Ms CT, Gerald LB, Dransfield M, Bamman M, Bonner J, Atkinson TP, Schwiebert LM. Feasibility of exercising adults with asthma: a randomized pilot study. Allergy Asthma Clin Immunol. 2012 Aug 3;8(1):13. doi: 10.1186/1710-1492-8-13.
Results Reference
background
PubMed Identifier
18080608
Citation
Westwood K, Griffin M, Roberts K, Williams M, Yoong K, Digger T. Incentive spirometry decreases respiratory complications following major abdominal surgery. Surgeon. 2007 Dec;5(6):339-42. doi: 10.1016/s1479-666x(07)80086-2.
Results Reference
background
PubMed Identifier
12358330
Citation
Lotters F, van Tol B, Kwakkel G, Gosselink R. Effects of controlled inspiratory muscle training in patients with COPD: a meta-analysis. Eur Respir J. 2002 Sep;20(3):570-6. doi: 10.1183/09031936.02.00237402.
Results Reference
background
PubMed Identifier
33809922
Citation
Chung Y, Huang TY, Liao YH, Kuo YC. 12-Week Inspiratory Muscle Training Improves Respiratory Muscle Strength in Adult Patients with Stable Asthma: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Mar 22;18(6):3267. doi: 10.3390/ijerph18063267.
Results Reference
background
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Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients
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