Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases (ET-fILD)

February 6, 2022 updated by: Hanaa Shafiek, Alexandria University

Effects of Different Exercise Training Programs on the Functional Performance in 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
The control group did not receive exercise training and the participants were informed to complete their medications provided by the treating physician.
Active Comparator: Lower limb (LL) exercise training
All the participants in this modality of training were subjected to only lower limbs aerobic exercise training.
Procedure: 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.
Other Names:
  • Lower limbs (LL) training
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum oxygen consumption
Time Frame: 6 weeks
Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 6 weeks
mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
6 weeks
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 (%).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0201313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are planning to share IPD but until now we did not decided as we need to talk with all the researchers conducted the trial before it is available for the public. For the time being, the data is available on request from the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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