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

NCT05227443 | Completed DMC

• 1 other identifier: 0201313
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Interstitial Lung Disease; Fibrosis Lung

Outcome Measures

Primary Outcomes (2)

• Maximum oxygen consumption

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

  6 weeks

• Quality of life evaluation

  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.

  6 weeks

Secondary Outcomes (2)

• Dyspnea

  6 weeks

• Resting oxygen saturation

  6 weeks

Study Arms (3)

Control

NO INTERVENTION

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

Lower limb (LL) exercise training

ACTIVE COMPARATOR

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

Procedure: Exercise aerobic training

Upper, lower and breathing (ULB) exercise training

ACTIVE COMPARATOR

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

Procedure: Upper, lower and breathing (ULB) exercise

Interventions

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.

Also known as: Lower limbs (LL) training

Lower limb (LL) exercise 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.

Upper, lower and breathing (ULB) exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine, Alexandria University

Alexandria, 21526, Egypt

Location

MeSH Terms

Conditions

Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis

Interventions

Respiration; Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: The current study has 2 groups of patients subjected to 2 different modalities of aerobic exercise training and a control group.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 7, 2022
• Study Start: January 16, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

EG (1)