Acute Hemodynamic Responses to Blood Flow Restriction Aerobic Exercise in Interstitial Lung Disease

NCT07315425 | Not Yet Recruiting

• 1 other identifier: 2025 - 1878
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Interstitial Lung Disease (ILD)

Keywords

Blood Flow Restriction; Interstitial Lung Disease; Muscle Oxygenation; Aerobic Exercise

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  Baseline (Day 1)

• Respiratory Muscle Strength

  Baseline (Day 1), Days 2 and 3

• Respiratory Muscle Endurance

  Baseline (Day 1)

• Peripheral Muscle Strength

  Baseline (Day 1), Days 2 and 3

Study Arms (2)

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).

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.

Other: Blood flow restriction (BFR) low-intensity aerobic exercise training

Interventions

Blood flow restriction (BFR) low-intensity aerobic exercise training OTHER

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.

Blood Flow Restriction (BFR) Low-Intensity Aerobic Exercise Group

Low-intensity aerobic exercise training OTHER

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).

Low-intensity Aerobic Exercise Training Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Presence of peripheral neuropathy.
• Resting blood pressure greater than 160/100 mmHg.
• History of deep vein thrombosis, pulmonary embolism, or stroke.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meral Boşnak Güçlü, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Şeyma Mutlu Kayaarslan, PT, MSc

  Başkent University and Gazi University

  STUDY CHAIR

• Betül Yoleri, PT, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün Yılmaz Demirci, Prof. Dr.

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral Boşnak Güçlü, Prof. Dr.

CONTACT

03122162647; meralbosnak@gazi.edu.tr

Şeyma Mutlu Kayaarslan, Pt. MsC

CONTACT

seyma.mutlu04@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is designed as triple-blind. Patients will not know their group assignment. All patients' assessments and training sessions will be conducted at different places and times. Evaluations and interventions will be performed by different physiotherapists. Patient groups will be coded before statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

TU (1)