Acute Hemodynamic Responses to Blood Flow Restriction Aerobic Exercise in Interstitial Lung Disease
NCT ID: NCT07315425
Last Updated: 2026-02-03
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-02-28
2028-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Low-intensity Aerobic Exercise Training Group
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).
Low-intensity aerobic exercise training
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).
Blood Flow Restriction (BFR) Low-Intensity Aerobic Exercise Group
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.
Blood flow restriction (BFR) low-intensity aerobic exercise training
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.
Interventions
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Blood flow restriction (BFR) low-intensity aerobic exercise training
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 training
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).
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in the study and provide written informed consent.
Exclusion Criteria
* 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.
* Presence of peripheral neuropathy.
* Resting blood pressure greater than 160/100 mmHg.
* History of deep vein thrombosis, pulmonary embolism, or stroke.
18 Years
75 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Prof. Dr.
Principal Investigators
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Meral Boşnak Güçlü, Prof. Dr.
Role: STUDY_DIRECTOR
Gazi University
Şeyma Mutlu Kayaarslan, PT, MSc
Role: STUDY_CHAIR
Başkent University and Gazi University
Betül Yoleri, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Nilgün Yılmaz Demirci, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Gazi University Faculty of Medicine
Locations
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Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2025 - 1878
Identifier Type: -
Identifier Source: org_study_id
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