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NCT Number: NCT05227443

Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases

The current study recruited patients with fibrosing interstitial lung diseases (f-ILD) whatever was the underlying pathology. The investigators aimed to compare the effects of aerobic exercises for lower limbs (LL) versus upper limbs, lower limbs, and breathing exercises (ULB) on the peak exercise measurements that was measured using cardiopulmonary exercise testing (CPET), dyspnea and health related quality of life assessment in this group of patients.

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Key information

Conditions

Lung Diseases Fibrosis Fibrosis Lung Interstitial Lung Disease Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Alexandria University

Alexandria, 21526, Egypt

About this study

The investigators conducted a case-control study with a follow up after 6 weeks (short term). All the participants on recruited were evaluated clinically. A high resolution computed tomography (HRCT) scan of the chest was performed to confirm the diagnosis of f-ILD as well as a spirometry. All the patients were subjected to cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), evaluation of dyspnea using mMRC dyspnea scale, and evaluation of health related quality of life using St. George's Respiratory Questionnaire (SGRQ). The control group were followed up by telephone calls. The intervention groups (LL and ULB) were subjected randomly to aerobic exercise training for 6 weeks. After termination of all the session, the patients were re-evaluated clinically and objectively using CPET, 6-MWT, mMRC and SGRQ. Also, we evaluated the outcome of the patients (control and intervention groups) as those who died or reported exacerbation of the underlying disease were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged ≥ 18 years.
  • Fibrosis interstitial lung diseases (f-ILDs) diagnosed based on HRCT radiological features.
  • Restrictive or mixed pattern in forced spirometry test

Exclusion criteria

  • Motor disabilities
  • Cardiovascular diseases (as acute heart failure, unstable angina or recent myocardial infarction)
  • Cognitive impairments
  • History of cerebrovascular accident
  • Active cancer
  • Life expectancy less than 3 months.

Treatment and study plan

Exercise aerobic training

Procedure

It is a procedure that is in the form of exercise training as a part of rehabilitation. The patients were subjected to 3 supervised sessions of exercise training / week for a total duration of 6 weeks. The form of training was aerobic intensity exercise that lasts for 15 minutes of continuous exercise. In this intervention, the investigators provide only lower limbs training exercises.

Other names: Lower limbs (LL) training

Upper, lower and breathing (ULB) exercise

Procedure

It is a procedure that is in the form of exercise training as a part of rehabilitation. The patients were subjected to 3 supervised sessions of exercise training / week for a total duration of 6 weeks. The form of training was aerobic intensity exercise that lasts for 15 minutes of continuous exercise. In this intervention, the investigators provide lower and upper limbs training exercises as well as breathing exercises.

Primary outcomes

  1. Maximum oxygen consumption

    Time frame: 6 weeks

    Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.

  2. Quality of life evaluation

    Time frame: 6 weeks

    St. George's Respiratory Questionnaire (SGRQ) was used to assess the health related quality of life. SGRS constitutes 50 items and the score ranging from 0 to 100, with higher scores indicating more limitations.

Secondary outcomes

  1. Dyspnea

    Time frame: 6 weeks

    mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.

  2. Resting oxygen saturation

    Time frame: 6 weeks

    Pulse oximeter was used to assess the change in oxygen saturation (SaO2) at rest after termination of exercise sessions. SaO2 is presented as percentage (%).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases

Acronym: ET-fILD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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