Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Bahçelievler Public Hospital
-
-
Eyüp
-
Istanbul, Eyüp, Turkey (Türkiye)
- Bezmialem Vakıf University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with asthma
- Acceptance of persons to participate in the study
- Being in the 18-65 age range
Exclusion Criteria:
- Presence of an orthopedic, neurological, systemic disease that prevents the exercise
- Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
- Exercising 3 or more days a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention group
A home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist.
|
Patients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist.
The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking).
All of these exercises will be equipped with equipment that the patients can easily provide at home.
In addition, patients will be provided with a pedometer and exercise diary.
|
|
Active Comparator: Control group
A training session about the disease and the correct inhaler use, booklets that include physical activity recommendations.
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The control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on physical activity recommendations.
Patients will be given a pedometer and diary.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnoea
Time Frame: 8 weeks
|
Change of Medical Research Council Scale results from baseline to 8 weeks.
The Medical Research Council Scale (MRCS) is a five-item scale based on various physical activities that produce dyspnea.
Here, patients are asked to mark the level of activity that causes dyspnea in themselves.
On the scale, 0 describes the best 4 dyspnea and the worst.
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8 weeks
|
|
Functional Capacity
Time Frame: 8 weeks
|
Change of Six-Minute Walking Test Distance from baseline to 8 weeks.The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes.
The distance that normal individuals should take in this period is 400-700 meters.
In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing.
Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
|
8 weeks
|
|
Peak Expiratory Flow
Time Frame: 8 weeks
|
Change of Expiratory Flow (PEF) from baseline to 8 weeks.
|
8 weeks
|
|
Forced Expiratory Volume in 1 second
Time Frame: 8 weeks
|
Change of Forced Expiratory Volume in 1 second (FEV1) from baseline to 8 weeks.
|
8 weeks
|
|
Control of Asthma
Time Frame: 8 weeks
|
Change of Asthma Control Test from baseline to 8 weeks.
The Asthma Control Test is a 5-item questionnaire that enables the patient to assess his / her own level of exposure to asthma activities, frequency of day and night asthma symptoms, need for rescue medication, and disease control.
Patients will be asked to answer the asthma control test, which includes scores associated with the answer to each question, and the total score will be 25 if complete control, 20-24 as partial control, and <19 as uncontrolled.
|
8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Extremity Strength and Dynamic Balance
Time Frame: 8 weeks
|
Change of 30 seconds sit and stand test results from baseline to 8 weeks.
|
8 weeks
|
|
Health Related Quality of Life
Time Frame: 8 weeks
|
Change of Saint George Respiratory Questionnaire Results from baseline to 8 weeks.It is a self-answered questionnaire consisting of three categories, evaluating the symptoms, activities and effects of patients on daily life.
It was developed in order to determine the severity of the disease as more comprehensive and sensitive.
Symptoms examined; cough, sputum, wheezing and shortness of breath.
Physical functions, housework and hobbies are questioned to determine activity status.
The survey consists of 76 questions and is completed in 20 minutes.
0 indicates excellent health and 100 indicates worst health.
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8 weeks
|
|
Activity of Daily Living
Time Frame: 8 weeks
|
Change of London Chest Activity of Daily Living Scale results from baseline to 8 weeks.
This questionnaire consisting of 15 items; personal care (4 items-dry, dress up upper body, wear shoes / socks, wash hair), housework (make 6 items-bed, change sheets, window / curtain wash, clean / remove dust, wash dishes, sweep), physical activity (2 items-stairs, leaning) and leisure (3 items-walking in the house, socially go out, talk) consists of four components.
Each item is given a score ranging from 0 to 5. Higher scores indicate higher limitation.
The scale can be evaluated as total score, component score and question score.
The total score can reach up to 75.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ayşe Sena Manzak, PhD Student, Bezmialem Vakif University
- Study Director: Semiramis Özyılmaz, Assoc. Prof., Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- BVUaysesena01
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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