Interstitial Lung Disease (ILD)NCT07315425
Acute Hemodynamic Responses to Blood Flow Restriction Aerobic Exercise in Interstitial Lung Disease
A study testing Blood flow restriction (BFR) low-intensity aerobic exercise training and Low-intensity aerobic exercise training in people with Interstitial Lung Disease (ILD), run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- Blood flow restriction (BFR) low-intensity aerobic exercise training and Low-intensity aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Receiving treatments outside standard medical therapy.
- Presence of peripheral arterial disease.
Show all 9Show fewer
- Presence of peripheral neuropathy.
- Resting blood pressure greater than 160/100 mmHg.
- History of deep vein thrombosis, pulmonary embolism, or stroke.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
About this study
Official title: Investigation of the Acute Effects of Blood Flow Restriction Aerobic Exercise on Hemodynamic Responses and Muscle Oxygen in Patients With Interstitial Lung Disease
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.
Read the detailed description
Interstitial lung diseases (ILD) constitute a group of disorders that diffusely affect the lungs, causing varying degrees of inflammation, fibrosis, and structural alterations in the lung parenchyma. These diseases may present with either acute or chronic progression and can involve not only the interstitium but also the alveoli, small airways, vascular structures, and pleura. The etiology of ILD is diverse and may be related to identifiable causes such as environmental or occupational exposures, medications, and radiation. Connective tissue diseases-including rheumatoid arthritis, systemic sclerosis, and systemic lupus erythematosus-along with several systemic disorders, may also lead to pulmonary damage and involvement. Systemic diseases can affect the lungs through infections, vasculitis, or inflammatory mechanisms. Globally, approximately two million individuals are affected by ILD, and in Türkiye, the incidence has been reported as 25.8 per 100,000. The most frequently encountered ILD subtypes include sarcoidosis, idiopathic pulmonary fibrosis, and hypersensitivity pneumonitis .
Dyspnea is one of the most common and disabling symptoms in individuals with ILD, substantially reducing quality of life. Respiratory irregularities observed at rest become more pronounced during exercise. Chronic cough is another prevalent symptom in ILD that negatively impacts daily functioning, social interactions, and psychological well-being, and may also indicate disease progression. Impaired gas exchange and reduced lung elasticity lead to a significant decrease in exercise capacity in ILD, resulting in limitations in daily activities. Assessment of exercise capacity is essential for monitoring disease severity and evaluating treatment effectiveness.
In individuals with ILD, progressive circulatory limitations reduce oxygen consumption. Fibrotic changes in the pulmonary vascular bed restrict blood flow, compromising oxygen delivery during exertion and leading to a marked reduction in VO₂ capacity. Pulmonary hypertension and decreased cardiac output further exacerbate this mechanism. During exercise, the oxygen pulse shows limited increase and may plateau or even decrease in some patients. Consequently, heart rate rises disproportionately compared with healthy individuals, increasing peripheral hypoxia and exercise-induced desaturation. Monitoring muscle oxygenation is important for determining how exercise interventions can be optimized to reduce dyspnea and improve exercise capacity.
Blood flow restriction (BFR) exercise was first introduced in 1966; however, it gained more attention in the mid-1980s due to its potential to induce strength gains at low exercise intensities, thereby reducing orthopedic injury risk. The technique relies on applying controlled external pressure to restrict venous return without completely occluding arterial inflow. This results in a temporary hypoxic and metabolically stressful environment distal to the cuff. Accumulation of lactic acid within the ischemic and hypoxic muscle environment leads to a decrease in intramuscular pH. These metabolic stress responses, which are typically observed during high-intensity exercise, stimulate growth hormone release. Growth hormone-mediated IGF-1 secretion enhances protein synthesis within muscle cells, ultimately promoting muscle hypertrophy. A key advantage of restricting blood flow during aerobic exercise is the potential to increase muscle mass even during low-intensity training .
In recent years, the applicability of BFR exercise has been demonstrated across various populations, including older adults, individuals with obesity, and those with cardiovascular conditions. However, most studies have been conducted in athletes and healthy individuals, and research in clinical populations remains limited. For individuals with ILD, BFR training may offer a safe and practical method to enhance both muscle mass and exercise capacity while imposing minimal stress on the cardiovascular and musculoskeletal systems.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- Blood flow restriction (BFR) low-intensity aerobic exercise training, Low-intensity aerobic exercise training
- Keywords
- Blood Flow Restriction, Interstitial Lung Disease, Muscle Oxygenation, Aerobic Exercise
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR) low-intensity aerobic exercise trainingOther
Participants 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 trainingOther
Participants 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).
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity Aerobic Exercise Training Group | Active comparator | Participants will perform the treadmill protocol (5-minute warm-up, 20-minute loading, 5-minute cool-down; intensity 30-39% HRR or 30-39% peak VO₂). Receives: Other: Low-intensity aerobic exercise training |
| Blood Flow Restriction (BFR) Low-Intensity Aerobic Exercise Group | Experimental | Participants will perform the treadmill protocol (5-minute warm-up, 20-minute loading, 5-minute cool-down; intensity 30-39% HRR or 30-39% peak VO₂) with the addition of blood flow restriction. Receives: Other: Blood flow restriction (BFR) low-intensity aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Hemodynamic Responses (Peripheral Oxygen Saturation (SpO₂))
Oxygen saturation will be recorded using a portable pulse oximeter (SpO₂, %) at baseline, immediately after exercise, and during the first minute of recovery.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Hemodynamic Responses (Respiratory Rate)
Respiratory rate (breaths per minute) will be counted manually or with a monitor before exercise, immediately post-exercise, and at the first minute of recovery.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Hemodynamic Responses (Dyspnea)
Subjective perception of breathlessness will be assessed using the Modified Borg Scale (0-10) before exercise, at peak exercise, immediately after exercise, and at the first minute of recovery. Modified Borg Scale: The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Hemodynamic Responses (Fatigue (Whole-body and Leg))
Perceived overall fatigue and leg fatigue will be assessed using the Modified Borg Scale (0-10) at the same time points as dyspnea. Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Hemodynamic Responses (Maximum Heart Rate)
The highest heart rate reached during the exercise session will be documented.
Measured: During the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Secondary outcomes (10)
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.
Measured: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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.
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1), Days 2 and 3
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed using incremental threshold loading with a Powerbreathe® device.
Measured: Baseline (Day 1)
Peripheral Muscle Strength
Quadriceps and shoulder abductor strength will be assessed using a handheld dynamometer. Three measurements will be taken, and the highest value will be recorded. Baseline assessments represent pre-exercise measurements. Day 2 and Day 3 correspond to the first and second exercise sessions, respectively.
Measured: Baseline (Day 1), Days 2 and 3
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. With the device, forced vital capacity (FVC) will be evaluated.
Measured: Baseline (Day 1)
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Measured: Baseline (Day 1)
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, FEV1 / FVC will be evaluated.
Measured: Baseline (Day 1)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Measured: Baseline (Day 1)
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, peak flow rate (PEF) will be evaluated.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral Boşnak Güçlü, Prof. Dr., Study director, Gazi UniversityŞeyma Mutlu Kayaarslan, PT, MSc, Study chair, Başkent University and Gazi UniversityBetül Yoleri, PT, MSc, Principal investigator, Gazi UniversityNilgün Yılmaz Demirci, Prof. Dr., Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315425
- Sponsor's protocol ID
- 2025 - 1878
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freitas EDS, Karabulut M, Bemben MG. The Evolution of Blood Flow Restricted Exercise. Front Physiol. 2021 Dec 2;12:747759. doi: 10.3389/fphys.2021.747759. eCollection 2021.
PubMed 34925056Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
PubMed 31156448Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.
PubMed 23513249Dipla K, Boutou AK, Markopoulou A, Pitsiou G, Papadopoulos S, Chatzikosti A, Stanopoulos I, Zafeiridis A. Exertional Desaturation in Idiopathic Pulmonary Fibrosis: The Role of Oxygen Supplementation in Modifying Cerebral-Skeletal Muscle Oxygenation and Systemic Hemodynamics. Respiration. 2021;100(6):463-475. doi: 10.1159/000514320. Epub 2021 Mar 30.
PubMed 33784706Degani-Costa LH, Levarge B, Digumarthy SR, Eisman AS, Harris RS, Lewis GD. Pulmonary vascular response patterns during exercise in interstitial lung disease. Eur Respir J. 2015 Sep;46(3):738-49. doi: 10.1183/09031936.00191014. Epub 2015 May 14.
PubMed 25976688Hansen JE, Wasserman K. Pathophysiology of activity limitation in patients with interstitial lung disease. Chest. 1996 Jun;109(6):1566-76. doi: 10.1378/chest.109.6.1566.
PubMed 8769513Kozu R, Shingai K, Hanada M, Oikawa M, Nagura H, Ito H, Kitagawa C, Tanaka T. Respiratory Impairment, Limited Activity, and Pulmonary Rehabilitation in Patients with Interstitial Lung Disease. Phys Ther Res. 2021 Apr 1;24(1):9-16. doi: 10.1298/ptr.R0012. eCollection 2021.
PubMed 33981523Bonini M, Fiorenzano G. Exertional dyspnoea in interstitial lung diseases: the clinical utility of cardiopulmonary exercise testing. Eur Respir Rev. 2017 Feb 21;26(143):160099. doi: 10.1183/16000617.0099-2016. Print 2017 Jan.
PubMed 28223398Garner J, George PM, Renzoni E. Cough in interstitial lung disease. Pulm Pharmacol Ther. 2015 Dec;35:122-8. doi: 10.1016/j.pupt.2015.10.009. Epub 2015 Nov 3.
PubMed 26545874Datta D, Normandin E, ZuWallack R. Cardiopulmonary exercise testing in the assessment of exertional dyspnea. Ann Thorac Med. 2015 Apr-Jun;10(2):77-86. doi: 10.4103/1817-1737.151438.
PubMed 25829957Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066Demedts M, Wells AU, Anto JM, Costabel U, Hubbard R, Cullinan P, Slabbynck H, Rizzato G, Poletti V, Verbeken EK, Thomeer MJ, Kokkarinen J, Dalphin JC, Taylor AN. Interstitial lung diseases: an epidemiological overview. Eur Respir J Suppl. 2001 Sep;32:2s-16s.
PubMed 11816822Tomlinson OW, Markham L, Wollerton RL, Knight BA, Duckworth A, Gibbons MA, Scotton CJ, Williams CA. Validity and repeatability of cardiopulmonary exercise testing in interstitial lung disease. BMC Pulm Med. 2022 Dec 22;22(1):485. doi: 10.1186/s12890-022-02289-0.
PubMed 36550475Molgat-Seon Y, Schaeffer MR, Ryerson CJ, Guenette JA. Exercise Pathophysiology in Interstitial Lung Disease. Clin Chest Med. 2019 Jun;40(2):405-420. doi: 10.1016/j.ccm.2019.02.011.
PubMed 31078218Gaunaurd IA, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Cahalin LP, Cardenas DD, Jackson RM. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. 2014 Dec;59(12):1872-9. doi: 10.4187/respcare.03180. Epub 2014 Sep 2.
PubMed 25185149
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Blood Flow Restriction Aerobic Exercise on Hemodynamic Responses and Muscle Oxygen in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07315425
- Acronym / sponsor ID
- 2025 - 1878
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- Blood Flow Restriction, Interstitial Lung Disease, Muscle Oxygenation, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interstitial lung diseases (ILD) constitute a group of disorders that diffusely affect the lungs, causing varying degrees of inflammation, fibrosis, and structural alterations in the lung parenchyma. These diseases may present with either acute or chronic progression and can involve not only the interstitium but also the alveoli, small airways, vascular structures, and pleura. The etiology of ILD is diverse and may be related to identifiable causes such as environmental or occupational exposures, medications, and radiation. Connective tissue diseases-including rheumatoid arthritis, systemic sclerosis, and systemic lupus erythematosus-along with several systemic disorders, may also lead to pulmonary damage and involvement. Systemic diseases can affect the lungs through infections, vasculitis, or inflammatory mechanisms. Globally, approximately two million individuals are affected by ILD, and in Türkiye, the incidence has been reported as 25.8 per 100,000. The most frequently encountered ILD subtypes include sarcoidosis, idiopathic pulmonary fibrosis, and hypersensitivity pneumonitis .
Dyspnea is one of the most common and disabling symptoms in individuals with ILD, substantially reducing quality of life. Respiratory irregularities observed at rest become more pronounced during exercise. Chronic cough is another prevalent symptom in ILD that negatively impacts daily functioning, social interactions, and psychological well-being, and may also indicate disease progression. Impaired gas exchange and reduced lung elasticity lead to a significant decrease in exercise capacity in ILD, resulting in limitations in daily activities. Assessment of exercise capacity is essential for monitoring disease severity and evaluating treatment effectiveness.
In individuals with ILD, progressive circulatory limitations reduce oxygen consumption. Fibrotic changes in the pulmonary vascular bed restrict blood flow, compromising oxygen delivery during exertion and leading to a marked reduction in VO₂ capacity. Pulmonary hypertension and decreased cardiac output further exacerbate this mechanism. During exercise, the oxygen pulse shows limited increase and may plateau or even decrease in some patients. Consequently, heart rate rises disproportionately compared with healthy individuals, increasing peripheral hypoxia and exercise-induced desaturation. Monitoring muscle oxygenation is important for determining how exercise interventions can be optimized to reduce dyspnea and improve exercise capacity.
Blood flow restriction (BFR) exercise was first introduced in 1966; however, it gained more attention in the mid-1980s due to its potential to induce strength gains at low exercise intensities, thereby reducing orthopedic injury risk. The technique relies on applying controlled external pressure to restrict venous return without completely occluding arterial inflow. This results in a temporary hypoxic and metabolically stressful environment distal to the cuff. Accumulation of lactic acid within the ischemic and hypoxic muscle environment leads to a decrease in intramuscular pH. These metabolic stress responses, which are typically observed during high-intensity exercise, stimulate growth hormone release. Growth hormone-mediated IGF-1 secretion enhances protein synthesis within muscle cells, ultimately promoting muscle hypertrophy. A key advantage of restricting blood flow during aerobic exercise is the potential to increase muscle mass even during low-intensity training .
In recent years, the applicability of BFR exercise has been demonstrated across various populations, including older adults, individuals with obesity, and those with cardiovascular conditions. However, most studies have been conducted in athletes and healthy individuals, and research in clinical populations remains limited. For individuals with ILD, BFR training may offer a safe and practical method to enhance both muscle mass and exercise capacity while imposing minimal stress on the cardiovascular and musculoskeletal systems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity Aerobic Exercise Training Group | Active comparator | Other: Low-intensity aerobic exercise trainingParticipants will perform the treadmill protocol (5-minute warm-up, 20-minute loading, 5-minute cool-down; intensity 30-39% HRR or 30-39% peak VO₂). |
| Blood Flow Restriction (BFR) Low-Intensity Aerobic Exercise Group | Experimental | Other: Blood flow restriction (BFR) low-intensity aerobic exercise trainingParticipants will perform the treadmill protocol (5-minute warm-up, 20-minute loading, 5-minute cool-down; intensity 30-39% HRR or 30-39% peak VO₂) with the addition of blood flow restriction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Receiving treatments outside standard medical therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction (BFR) low-intensity aerobic exercise trainingParticipants 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. | Other | Blood Flow Restriction (BFR) Low-Intensity Aerobic Exercise Group |
| Low-intensity aerobic exercise trainingParticipants 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). | Other | Low-intensity Aerobic Exercise Training Group |
Primary outcome
Hemodynamic Responses
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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)
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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)
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
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)
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Diastolic blood pressure will be measured in mmHg using a sphygmomanometer before exercise, immediately post-exercise, and at the first minute of recovery.
Hemodynamic Responses (Peripheral Oxygen Saturation (SpO₂))
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Oxygen saturation will be recorded using a portable pulse oximeter (SpO₂, %) at baseline, immediately after exercise, and during the first minute of recovery.
Hemodynamic Responses (Respiratory Rate)
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Respiratory rate (breaths per minute) will be counted manually or with a monitor before exercise, immediately post-exercise, and at the first minute of recovery.
Hemodynamic Responses (Dyspnea)
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Subjective perception of breathlessness will be assessed using the Modified Borg Scale (0-10) before exercise, at peak exercise, immediately after exercise, and at the first minute of recovery. Modified Borg Scale: The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Hemodynamic Responses (Fatigue (Whole-body and Leg))
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Perceived overall fatigue and leg fatigue will be assessed using the Modified Borg Scale (0-10) at the same time points as dyspnea. Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means.
Hemodynamic Responses (Maximum Heart Rate)
Time frame: During the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
The highest heart rate reached during the exercise session will be documented.
10 secondary outcomes
Muscle Oxygenation
Time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.
Maximal Exercise Capacity
Time frame: Baseline (Day 1)
Respiratory Muscle Strength
Time frame: Baseline (Day 1), Days 2 and 3
Respiratory Muscle Endurance
Time frame: Baseline (Day 1)
Peripheral Muscle Strength
Time frame: Baseline (Day 1), Days 2 and 3
Pulmonary function (Forced vital capacity (FVC))
Time frame: Baseline (Day 1)
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: Baseline (Day 1)
Pulmonary function (FEV1 / FVC)
Time frame: Baseline (Day 1)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: Baseline (Day 1)
Pulmonary function (Peak flow rate (PEF))
Time frame: Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 34925056Freitas EDS, Karabulut M, Bemben MG. The Evolution of Blood Flow Restricted Exercise. Front Physiol. 2021 Dec 2;12:747759. doi: 10.3389/fphys.2021.747759. eCollection 2021.
- Background: PubMed 31156448Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
- Background: PubMed 23513249Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.
- Background: PubMed 33784706Dipla K, Boutou AK, Markopoulou A, Pitsiou G, Papadopoulos S, Chatzikosti A, Stanopoulos I, Zafeiridis A. Exertional Desaturation in Idiopathic Pulmonary Fibrosis: The Role of Oxygen Supplementation in Modifying Cerebral-Skeletal Muscle Oxygenation and Systemic Hemodynamics. Respiration. 2021;100(6):463-475. doi: 10.1159/000514320. Epub 2021 Mar 30.
- Background: PubMed 25976688Degani-Costa LH, Levarge B, Digumarthy SR, Eisman AS, Harris RS, Lewis GD. Pulmonary vascular response patterns during exercise in interstitial lung disease. Eur Respir J. 2015 Sep;46(3):738-49. doi: 10.1183/09031936.00191014. Epub 2015 May 14.
- Background: PubMed 8769513Hansen JE, Wasserman K. Pathophysiology of activity limitation in patients with interstitial lung disease. Chest. 1996 Jun;109(6):1566-76. doi: 10.1378/chest.109.6.1566.
- Background: PubMed 33981523Kozu R, Shingai K, Hanada M, Oikawa M, Nagura H, Ito H, Kitagawa C, Tanaka T. Respiratory Impairment, Limited Activity, and Pulmonary Rehabilitation in Patients with Interstitial Lung Disease. Phys Ther Res. 2021 Apr 1;24(1):9-16. doi: 10.1298/ptr.R0012. eCollection 2021.
- Background: PubMed 28223398Bonini M, Fiorenzano G. Exertional dyspnoea in interstitial lung diseases: the clinical utility of cardiopulmonary exercise testing. Eur Respir Rev. 2017 Feb 21;26(143):160099. doi: 10.1183/16000617.0099-2016. Print 2017 Jan.
- Background: PubMed 26545874Garner J, George PM, Renzoni E. Cough in interstitial lung disease. Pulm Pharmacol Ther. 2015 Dec;35:122-8. doi: 10.1016/j.pupt.2015.10.009. Epub 2015 Nov 3.
- Background: PubMed 25829957Datta D, Normandin E, ZuWallack R. Cardiopulmonary exercise testing in the assessment of exertional dyspnea. Ann Thorac Med. 2015 Apr-Jun;10(2):77-86. doi: 10.4103/1817-1737.151438.
- Background: PubMed 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Background: PubMed 11816822Demedts M, Wells AU, Anto JM, Costabel U, Hubbard R, Cullinan P, Slabbynck H, Rizzato G, Poletti V, Verbeken EK, Thomeer MJ, Kokkarinen J, Dalphin JC, Taylor AN. Interstitial lung diseases: an epidemiological overview. Eur Respir J Suppl. 2001 Sep;32:2s-16s.
Related trials for Interstitial Lung Disease (ILD)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Boşnak Güçlü, Prof. Dr. study director
Gazi University
Şeyma Mutlu Kayaarslan, PT, MSc study chair
Başkent University and Gazi University
Betül Yoleri, PT, MSc principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) low-intensity aerobic exercise training and Low-intensity aerobic exercise training in people with Interstitial Lung Disease (ILD), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Responses (time frame: Pre-exercise and during the exercise test on Day 1, and pre-exercise and during the first and second exercise sessions on Days 2 and 3.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315425, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.