Clinical trial NCT05227443: Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases
Official title: Effects of Different Exercise Training Programs on the Functional Performance in Fibrosing Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Interstitial Lung Disease
Fibrosis Lung
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study has 2 groups of patients subjected to 2 different modalities of aerobic exercise training and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum oxygen consumption
timeFrame: 6 weeks
measure: Quality of life evaluation
timeFrame: 6 weeks
Secondary outcomes:
measure: Dyspnea
timeFrame: 6 weeks
measure: Resting oxygen saturation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of medicine, Alexandria University
Study officials:
References: