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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06133998
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Riphah International University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

sumera abdul hameed, Ms
Principal Investigator Affiliation Riphah International University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Pakistan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: incentive spirometry 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.

Active Comparator: 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.

Interventions

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.

Device: - 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.

Contact a Trial Team

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International Sites

Ittefaq Hospital, Lahore, Punjab, Pakistan

Status

Recruiting

Address

Ittefaq Hospital

Lahore, Punjab, 042

Site Contact

sumera abdul hameed, MS

sumera.hameed@riphah.edu.pk

03104548492