Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient
Primary Purpose
Asthmatic
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Laura Mitchell's Relaxation technique
Papworth exercise
Sponsored by
About this trial
This is an interventional treatment trial for Asthmatic
Eligibility Criteria
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
Sites / Locations
- Laeeque Rafiq HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laura Mitchell's Relaxation technique
Papworth exercise
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05915845
First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05915845
Brief Title
Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient
Official Title
Effects of Laura Mitchell's Relaxation Versus Papworth Exercise on Dyspnea, Fatigue, and Sleep Quality in Ashmatic Patient
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 30, 2023 (Anticipated)
Study Completion Date
August 30, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laura Mitchell's Relaxation technique
Arm Type
Experimental
Arm Title
Papworth exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Laura Mitchell's Relaxation technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Papworth exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulse Oximeter
Description
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
Time Frame
6 weeks
Title
COPD and Asthma fatigue scale
Description
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
Time Frame
6 weeks
Title
Dyspnea 12 scale
Description
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
Time Frame
6 weeks
Title
Pittsburgh sleep quality index
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Laeeque Rafiq Hospital
City
Lar
State/Province
Punjab
ZIP/Postal Code
61000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameena Amjad, tDPT
Phone
03234184526
12. IPD Sharing Statement
Plan to Share IPD
No
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Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient
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