About this trial
Interstitial lung diseases (ILD)impaired gas exchange and reduced lung elasticity lead to marked reductions in exercise capacity and decreased oxygen consumption due to circulatory limitations. Blood flow restriction (BFR) exercise involves applying external pressure to partially restrict venous return without entirely blocking arterial inflow. This controlled compression induces temporary hypoxic and metabolic stress, triggering high-intensity-like responses that stimulate growth hormone release, increase protein synthesis, and promote muscle hypertrophy. However, the most crucial advantage of blood flow restriction during exercise is its ability to increase muscle mass during aerobic training. IIn individuals with ILD, BFR may offer a safe and practical way to improve muscle mass and exercise capacity with minimal additional strain on the cardiovascular and musculoskeletal systems.Our study aimed to compare the acute effects of low-intensity blood flow restriction aerobic exercise training and low-intensity aerobic exercise training on hemodynamic responses and muscle oxygenation in patients with ILD. Method: 30 patients with a diagnosis of ILD being followed up will be included in the study. Our study was a randomized, crossover, triple-blind, prospective study. Assessments will be performed at the beginning of the study. On the first day, demographic data and clinical findings of the individuals will be collected. Patients will be asked questions, and their responses will be recorded in their medical records. Respiratory function, respiratory muscle strength and endurance, and peripheral muscle strength will be evaluated. 48 hours from the first day, patients' maximal exercise capacity will be assessed with a cardiopulmonary exercise test (CPET), and muscle oxygenation during CPET will be assessed with a Moxy® monitor. Respiratory muscle fatigue will be assessed with an oral pressure monitor before and after the exercise test. The assessments will be completed over two days. One week after the evaluations, patients will be randomly assigned to two groups. One group will receive low-intensity aerobic exercise training, and the other will receive low-intensity aerobic exercise training with blood flow restriction. Muscle oxygenation will be assessed during both exercise sessions, and respiratory muscle fatigue will be measured before and after each session. All participants will receive both exercise sessions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of interstitial lung disease according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) diagnostic criteria.
Willingness to participate in the study and provide written informed consent.
Disqualifiers
Presence of any acute infection at the time of the study.
Orthopedic or neurological conditions that may affect exercise capacity.
Contraindications to exercise testing according to the American College of Sports Medicine (ACSM) guidelines.
History of COVID-19 infection within the last three months.
Trial design
Crossover
Treatments tested in this trial
Blood flow restriction (BFR) low-intensity aerobic exercise training
Other interventionParticipants will perform a treadmill-based aerobic exercise session at 30-39% of heart rate reserve (HRR) or 30-39% of peak VO₂. The session will consist of 5 minutes of warm-up, 20 minutes of training at target intensity, and 5 minutes of cool-down (total duration: 30 minutes). Before the loading phase begins, a pneumatic external compression device will be placed around both thighs. Blood flow restriction will be applied only during the 20-minute loading phase and will not be used during warm-up or cool-down.
Low-intensity aerobic exercise training
Other interventionParticipants will perform a single supervised aerobic exercise session on a treadmill under physiotherapist supervision. Exercise intensity will be set at 30-39% of heart rate reserve (HRR) or 30-39% of peak VO₂. The protocol will consist of 5 minutes of warm-up, 20 minutes of training at target intensity, and 5 minutes of cool-down (total duration: 30 minutes).
Treatment groups
Trial outcomes
Primary outcomes
Hemodynamic Responses
The primary outcome of the study will be the acute hemodynamic responses to low-intensity aerobic exercise with and without blood flow restriction in individuals with interstitial lung disease. Heart rate, respiratory rate, systolic and diastolic blood pressure, and peripheral oxygen saturation will be recorded. Maximum heart rate, perceived dyspnea, and fatigue levels reached during the exercise workload will also be documented. Hemodynamic responses will be assessed during two exercise sessions (Session 1 and Session 2), which are separated by a 7-day washout period. Measurements will be obtained before exercise (pre-exercise), during exercise, immediately after exercise, and at the first minute of recovery.
Hemodynamic Responses (Heart Rate)
Heart rate will be measured in beats per minute using a heart rate monitor before exercise, immediately after exercise, and at the first minute of recovery.
Hemodynamic Responses (Systolic Blood Pressure)
Systolic blood pressure will be measured in mmHg using a sphygmomanometer before exercise, immediately after exercise, and at the first minute of recovery.
Hemodynamic Responses (Diastolic Blood Pressure)
Diastolic blood pressure will be measured in mmHg using a sphygmomanometer before exercise, immediately post-exercise, and at the first minute of recovery.
Secondary outcomes
Muscle Oxygenation
Muscle oxygenation will be evaluated using the Moxy® muscle oxygen monitor during both cardiopulmonary exercise testing and exercise training sessions. Local muscle oxygen saturation (SmO₂) and total hemoglobin (THb) values will be recorded at rest, immediately after exercise, and at the first minute of recovery.
Maximal Exercise Capacity
Maximal exercise capacity will be evaluated with cardiopulmonary exercise testing (CPET). Breath-by-breath parameters including VO₂ (oxygen consumption, ml/min), VO₂/kg (oxygen consumption per kilogram per minute, ml/min/kg), METs (metabolic equivalents), V̇E (minute ventilation, L/min), V̇CO₂ (carbon dioxide production, ml/min), EqO₂ (ventilatory equivalent for oxygen), EqCO₂ (ventilatory equivalent for carbon dioxide), RER (respiratory exchange ratio), HR (heart rate, beats/min), HRR (heart rate reserve), VO₂/HR (oxygen pulse, ml), RR (respiratory rate, breaths/min), and SpO₂ (oxygen saturation, %) treadmill speed and gradient, and oxygen saturation will be continuously monitored.
Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using a portable mouth pressure device in accordance with American Thoracic Society and European Respiratory Society guidelines.Respiratory muscle fatigue assessments will be performed before and after exercise testing and repeated before and after each exercise intervention. Baseline assessments represent pre-exercise measurements. Day 2 and Day 3 correspond to the first and second exercise sessions, respectively.
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed using incremental threshold loading with a Powerbreathe® device.
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