Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

Effects of Incentive Spirometry With and Without Aerobic Exercises on Dyspnea, Exercise Capacity and Quality of Life in Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133998
• Other study ID #: REC/RCR & AHS/23/0349
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2023
• Source: Riphah International University
• Contact: imran amjad, phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of Incentive spirometry with and without Aerobic exercises on dyspnea, exercise capacity and quality of life in interstitial lung disease

Description:

Interstitial lung disease is the large group of diseases most of which cause progressive scarring of lung tissue. The scarring associated with interstitial lung disease eventually affects participants ability to breathe and get enough oxygen into participants bloodstream. This is occurring by the long term work in dusty places or factories Randomized control trials will be conducted in DHQ hospital Layyah through the convent sampling techniques on patients which will be allocated through convenience sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After the conventional treatment Group A will be treated with aerobic exercise and Group B will be treated without the aerobic exercise. In group A check the effect of spirometry with aerobic exercise (walking, jogging, running and cycling) and group B check the effect of spirometry without the aerobic exercise and dyspnea by using the 6 mint walk test, Borage scale, PFT, chest expansions and quality of life questionnaire. investigators apply the aerobic exercise by using the spirometer on the interstitial lung diseases patient and check the effectiveness of dyspnea, exercise capacity and quality of life of the patient. Data will be collect by the questioner and Data will be analyzed using SPSS software version 21. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 10, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients18 to 55 years of age (21)
• Both gender(M/F)
• Diagnosed as ILD ( sarcoidosis,acute interstitial pneumonia etc.)on clinical, radiological, and histopathological basis
• All included patients were clinically stable without exacerbations in the past 1 month.

Exclusion Criteria:

• Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, COPD, asthma, bronchiectasis, lung carcinoma, and pneumothorax
• connective tissue disease-associated ILD
• Patients having other co morbid diseases preventing from exercise training, for example, disability due to orthopedic, neurological, and acute cardiac causes
• Physically and mentally unwell to attend the hospital for training
• Already completed or participated in a PR program in the past 1 year

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Device:
• incentive spirometer with aerobic exercises
Group A: Aerobic exercise (running, jugging, cycling, walking) will be given to the group A for the checking the effect of incentive spirometer In sitting position, for the relaxation of body, patient will take a deep breath. In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. This schedule will be following supervised exercise training for a minimum 60 minutes 3 days a week in moderate patient,75 minutes in moderate to vigorous patients and 150 minutes in healthy patients We will check the dyspnea of the patient by the borage scale We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test We will check the quality of life by the questionnaire.
• incentive spirometry without aerobic exercises
Group B: In group B we will check the effects of incentive spirometer without the aerobic exercise. In aerobic exercise following treatment protocol will be involve In sitting position, for the relaxation of body, patient will take a deep breath. In sitting position, patient will sit on the chair, placed both feet on the floor while bending knee at 90 degree and use the incentive spirometer for the deep breath and check the volume of lung. We will check the dyspnea of the patient by the borage scale We will check the exercise capacity by the endurance training of respiratory muscles and use the 6 mint walk test We will check the quality of life by the questionnaire. We will check the chest expansion by measuring tap.

Locations

Country	Name	City	State
Pakistan	Ittefaq Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Bilyy A, El-Nakhal T, Kadlec J, Bartosik W, Tornout FV, Kouritas V. Preoperative training education with incentive spirometry may reduce postoperative pulmonary complications. Asian Cardiovasc Thorac Ann. 2020 Nov;28(9):592-597. doi: 10.1177/0218492320957158. Epub 2020 Sep 11. — View Citation

Ho SC, Chiang LL, Cheng HF, Lin HC, Sheng DF, Kuo HP, Lin HC. The effect of incentive spirometry on chest expansion and breathing work in patients with chronic obstructive airway diseases: comparison of two methods. Chang Gung Med J. 2000 Feb;23(2):73-9. — View Citation

Larson M, Kim MJ. Respiratory muscle training with the incentive spirometer resistive breathing device. Heart Lung. 1984 Jul;13(4):341-5. — View Citation

Rondinel TZ, Correa IF, Hoscheidt LM, Bueno MH, Da Silva LM, Reppold CT, Dal Lago P. Incentive spirometry combined with expiratory positive airway pressure improves asthma control and quality of life in asthma: a randomised controlled trial. J Asthma. 2015 Mar;52(2):220-6. doi: 10.3109/02770903.2014.956890. Epub 2014 Sep 2. — View Citation

Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC (force vital capacity)	Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the values of FVC (force vital capacity) in liters and in predicted % form . Normal value of FVC is 4.75 to 5.5 in male and 3.25 to3.75 in female.	6 weeks
Primary	The value of FEV1	Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. Spirometry the most common type of lung function test. It measures how much and how quickly you can move air in and out of your lungs. Measure the value of FEV1 in liters and in predicted% form. Normal FEV1 in male is3.5to 4.5 and in female is 2.5 to 3.25.	6 weeks
Primary	Borg scale	This scale use for the measurement of dyspnea (shortness of breath) Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is used in monitoring progress and mode of exercise in cardiac patients as well as in other patient populations undergoing rehabilitation and endurance training. According to the Borg scale maximum value is 9-10which shows the severe pain level in patient and the moderate pain value is 3-4 the minimum pain is values 1-2 .	6 weeks
Primary	6mint walk test	This test is performing for the measurement of aerobic capacity and endurance. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity	6 weeks
Primary	Quality of life questioner	This questioner is use for measure of physical, psychological and emotional wellbeing life. The QOLQ is a validated and reliable questionnaire that measures an individual's physical, psychological, and social well-being. It consists of a set of questions that cover various aspects of quality of life, such as physical health, emotional well-being, social support, and overall satisfaction with life	6 weeks
Primary	chest expansion	In this test we use the measuring tape for the measurement of chest mobility. Chest expansion, defined as the difference in thoracic girth after maximum inspiration and maximum expiration, is one indicator of chest wall mobility. As it is measured using a measuring tape, it is a simple, inexpensive, and noninvasive tool for assessing chest mobility.	6 weeks