Effects of Upper Extremity Aerobic Exercise Training in Patients With Interstitial Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2025-06-01

Brief Summary

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Severe dyspnea, cough, fatigue, restrictive type ventilation disorder, decreased pulmonary function, impaired gas exchange, decreased cardiovascular function and exercise intolerance are frequently encountered findings in patients with interstitial lung disease. It was demonstrated exercise training has beneficial effects in patients with interstitial lung disease. However, no study investigated the effects of upper extremity aerobic exercise training on outcomes in patients with interstitial lung disease.

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Detailed Description

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Interstitial lung diseases (ILD) are a heterogeneous group of diseases that cause significant mortality and morbidity worldwide. As a result of the chronic inflammatory process in this disease, structural and mechanical pulmonary disorders develop, which are considered the main causes of deterioration in cardiopulmonary functions. Interstitial lung patients have a decrease in both static and dynamic lung volumes and carbon monoxide diffusing capacity (DLCO). As a result of this pathological mechanism, effort dyspnea and an increase in exercise intolerance occur. Therefore, individuals with ILD tend to avoid activities that increase shortness of breath, resulting in decreased physical activity levels and an increased sedentary lifestyle. Individuals whose functional exercise capacities are also limited due to this vicious circle become more dependent in their daily living activities. In addition, peripheral muscle dysfunction is another important factor that causes exercise intolerance in individuals with all chronic lung diseases, including ILD. One of the most important mechanisms triggering peripheral muscle dysfunction in ILD is hypoxia which develops with desaturation. Hypoxia, which causes an increase in oxidative stress, is one of the factors that can cause muscle dysfunction. It has been reported that upper extremity exercise capacity and functional performance are low in individuals with advanced ILD, and it has been stated that upper extremity exercise training may be beneficial in these patients.

However, the effects of upper extremity aerobic exercise training have not been investigated in the literature in patients with ILD. In this context, the primary aim of our study is to investigate the effects of upper extremity interval aerobic exercise training applied to patients with ILD on oxygen consumption, muscle oxygenation, and physical activity level. The secondary aim of the study is to determine the effects of this training on upper extremity functional exercise capacity, respiratory functions, pulmonary diffusion capacity, respiratory and peripheral muscle strength, inspiratory muscle endurance, dyspnea, fatigue, quality of life, sleep quality, anxiety, and depression. For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 21 patients with a diagnosis of ILD will be included in the training and control groups.

The training group will be given upper extremity interval aerobic exercise training with arm ergometer for 30-45 minutes 3 days a week for 6 weeks, and the control group will not be given any training during the study. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

All assessments will be completed in two days, before and after six weeks of training.

Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times.

Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.

Study Groups

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Training Group

The training group will receive upper extremity high-intensity interval aerobic exercise training on an arm ergometer accompanied by a physiotherapist for 6 weeks.

Group Type EXPERIMENTAL

Upper extremity high-intensity interval aerobic exercise training

Intervention Type OTHER

High-intensity interval aerobic exercise training will be given to the training group on an arm ergometer 3 days in a week and 30-45 minutes a day for 6 weeks with the assistance of a physiotherapist. The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate. The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate.

In case of desaturation (\<90%) during the training in the patients in the training group, O2 support with a nasal cannula will be given to the patient.

Control Group

The control group will not be given any training for 6 weeks during the study period.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

The control group will not be given any training during the 6-week period. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

Interventions

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Upper extremity high-intensity interval aerobic exercise training

High-intensity interval aerobic exercise training will be given to the training group on an arm ergometer 3 days in a week and 30-45 minutes a day for 6 weeks with the assistance of a physiotherapist. The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate. The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate.

In case of desaturation (\<90%) during the training in the patients in the training group, O2 support with a nasal cannula will be given to the patient.

Intervention Type OTHER

Control Group

The control group will not be given any training during the 6-week period. After the study, the treatment applied to the training group will also be applied to the control group in order to ensure that the patients in the control group are not ethically deprived of rehabilitation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with ILD according to ATS/ERS criteria,
* Aged between 18-75 years,
* No pulmonary infection during the last month,
* Patients who volunteer to participate in the study

Exclusion Criteria

Patients with,

* Body mass index \>35 kg/m2,
* An acute pulmonary exacerbation within the last 4 weeks, have an acute upper or lower respiratory tract infection,
* Presence of obstructive pulmonary disease,
* Serious neurological, neuromuscular, orthopedic, or other diseases affecting physical functions,
* Participated in a planned exercise program within the last three months,
* Cognitive impairment that causes them to have difficulty understanding and following exercise test instructions,
* Contraindications for exercise testing and/or exercise training according to the American College of Sports Medicine
* Cancer, renal or hepatic diseases,
* Aortic stenosis, complex arrhythmia, with aortic aneurysm,
* Uncontrolled hypertension, diabetes mellitus, heart failure, arrhythmia and serious cardiovascular disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Meral Boşnak Güçlü

Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR