- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06762236
Combined Effects of Inspiratory Muscles Training With Pilate Training in Asthma Patients
Combined Effects of Inspiratory Muscles Training With Pilate Training on Dyspnea Cardiorespiratory Fitness Quality of Life in Asthma Patients
Asthma is a chronic (long-term) condition that affects the airways in the lungs. The airways are tubes that carry air in and out of your lungs. In asthma the airways can become inflamed and narrowed at times. This makes it harder for air to flow out of your airways when you breathe out. When symptoms get worse, it is called an asthma attack. There is no permeant cure for asthma, but medical treatment and physiotherapy treatment can help to manage it. There is many physiotherapy protocols can be used for asthma patients like aerobic exercises, breathing exercise etc. The objective of our study is determine the combine effects of inspiratory muscle training with Pilate training on dyspnea, cardiorespiratory fitness and quality of life in asthma patients.
The randomized control trial will used as study design as study design for this this purpose simple random sampling technique will be used to allocate the sample in two group The sample size will be calculated by the G-power analysis. This study will conduct in Jinnah Hospital, Lahore Group A will receive both inspiratory training and Pilate training and group B receive only Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly. This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds. Base line treatment is diaphragmatic breathing exercise .The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front. Pre and post measurement will be done using Juniper asthma quality of life, 6 mint walk test, Borges dyspnea scale and fatigue severity scale to measure the outcomes. Data will be analyzed SPSS version 25. T-test and Regression analysis will be used.
Key words: asthma patient, cardiorespiratory fitness, dyspnea, quality of life, Pilate training, inspiratory muscle training
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 05307
- Gulab Devi hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
- Medically cleared for cardiac rehabilitation.
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.
Exclusion criteria
- Status Asthmatics
- Patient with cardiac disease
- Age range from 30 to 50 (15)
- Both Male and Female
- FEV1 value range from 64% to less than 50%
- Medically cleared for cardiac rehabilitation.
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks.
|
.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks.
|
|
Placebo Comparator: Controlied Group
Inspiratory training, incentive spirometer the participants were instructed to hold the breath for 2-3 seconds then exhale slowly.
This process was repeated 10 times or about 10-15minutes with rest in between 30 seconds.
Base line treatment is diaphragmatic breathing exercise
|
.The session will repeated three times per week for 6 weeks with 40-minute sessions In Pilates we include 5 Pilate exercise, The Hundred (Rhythmic Breathing), Single Leg Stretch (Rhythmic Breathing), side kick, Toe Taps (Set Breathing Pattern) ,leg pull front for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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SF 36
Time Frame: 8 weeks
|
A disease-specific health-related quality of life instrument developed by E. Juniper in1999and colleagues that taps both physical and emotional impact of disease.
The instrument should not be confused with the measure developed by Marks and colleagues, which carries the same name.
Asthma Quality of Life Questionnaire (AQLQ or AQLQ-J) developed by Juniper and colleagues is a 32 questions instrument to measure the functional problems that are most troublesome to adults.
Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) Scaling of items 7-point Likert scale Scoring All items are weighted equally.
Mean score is calculated across all items within each domain.
Overall score is the mean across all items
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8 weeks
|
|
6MWT
Time Frame: 8 weeks
|
The 6MWT is a sub-maximal exercise test used to examine person aerobic capacity and endurance.
This test initially developed to make an assessment of patient with cardiopulmonary issues.
It is used to check the functional capacity of the individual and it provides useful information regarding all the body systems during physical activity, including cardiovascular and pulmonary system.
It can used for all age group range 2 to above 64 years The test is easy to perfume , with standardized limited instructions and encouragement being given as person walk as far as possible over 6 minutes through a flat corridor.
The final distance is recorded in meters6
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sumera Hameed, Mphill, Riphah International University
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
- Dureshawar Alamgir
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
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