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

NCT ID: NCT05227443

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2021-07-30

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.

Conditions

Lung Diseases; Interstitial Lung Disease; Fibrosis Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lower limb (LL) exercise training

All the participants in this modality of training were subjected to only lower limbs aerobic exercise training.

Group Type: ACTIVE_COMPARATOR

Exercise aerobic training

Intervention Type: 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.

Upper, lower and breathing (ULB) exercise training

All the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training.

Group Type: ACTIVE_COMPARATOR

Upper, lower and breathing (ULB) exercise

Intervention Type: 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.

Interventions

Exercise aerobic training

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.

Intervention Type: PROCEDURE

Upper, lower and breathing (ULB) exercise

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.

Intervention Type: PROCEDURE

Other Intervention Names

Lower limbs (LL) training

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Hanaa Shafiek

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0201313

Identifier Type: -

Identifier Source: org_study_id