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

NCT07315425 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-03

No results posted yet for this study

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)

Interventions

OTHER

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.

OTHER

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).

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Meral Boşnak Güçlü, Prof. Dr. · Gazi University

  • Şeyma Mutlu Kayaarslan, PT, MSc · Başkent University and Gazi University

  • Betül Yoleri, PT, MSc · Gazi University

  • Nilgün Yılmaz Demirci, Prof. Dr. · Gazi University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315425 on ClinicalTrials.gov