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

NCT06133998 | Unknown

• 1 other identifier: REC/RCR & AHS/23/0349
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interstitial Lung Disease

Keywords

shortness of breath ,cough,fatigue.

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

incentive spirometry with aerobic exercises

EXPERIMENTAL

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.

Device: incentive spirometer with aerobic exercises

incentive spirometry without aerobic exercises

ACTIVE COMPARATOR

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.

Device: incentive spirometry without aerobic exercises

Interventions

incentive spirometer with aerobic exercises DEVICE

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 with aerobic exercises

incentive spirometry without aerobic exercises DEVICE

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.

incentive spirometry without aerobic exercises

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ittefaq Hospital

Lahore, Punjab Province, 042, Pakistan

RECRUITING

Related 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.

  PMID: 32915659 BACKGROUND

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

  PMID: 6564101 BACKGROUND

• 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.

  PMID: 11069801 BACKGROUND

• 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.

  PMID: 10835801 BACKGROUND

• 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.

  PMID: 25144550 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sumera abdul hameed, Ms

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 18, 2023
• Study Start: September 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)