Continuous Versus High Intensity Interval Exercise in Chronic Obstructive Pulmonary Disease

NCT07707271 | Recruiting

• 1 other identifier: 8-31.04.2026 / ΔΔ5394
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is characterized by exercise intolerance, which is a prognostic factor of disease severity and mortality and is usually attributed to ventilatory limitations. Emerging evidence indicates that cerebral oxygenation may also be an important contributor, being impaired both at rest and during exercise in COPD patients. Furthermore, abnormal systemic hemodynamic responses and autonomic nervous system (ANS) dysfunction have been observed, which may further impair cerebral oxygenation. The type of exercise training applied in pulmonary rehabilitation (continuous versus interval) appears to influence these mechanisms differently, yet evidence on their impact on cerebral oxygenation in COPD remains scarce. The aim of this study is to compare, for the first time, the acute changes in cerebral oxygenation, CPET parameters, systemic hemodynamic responses, and autonomic responses in patients with COPD who undergo a high-intensity interval aerobic exercise (HIIE) protocol versus a moderate-intensity continuous aerobic exercise (MICE) protocol. These findings will have important clinical implications, as they may guide the choice of the most appropriate exercise modality in pulmonary rehabilitation.

Conditions

COPD

Outcome Measures

Primary Outcomes (63)

• Differences between MICE and HIIE protocol in brain HbO2 (changes from the baseline) during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain HbO2 (changes from the baseline) during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain HbO2 (changes from the baseline) during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain HHb (changes from the baseline) during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain HHb (changes from the baseline) during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain HHb (changes from the baseline) during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain tHb (changes from the baseline) during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain tHb (changes from the baseline) during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain tHb (changes from the baseline) during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain Hbdiff (changes from the baseline) during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain Hbdiff (changes from the baseline) during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in brain Hbdiff (changes from the baseline) during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2 during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2 during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2 during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in Vt during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in Vt during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in Vt during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RR during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RR during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RR during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RER during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RER during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in RER during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in PETCO2 during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in PETCO2 during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in PETCO2 during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE/ VCO2 during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE/ VCO2 during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VE/ VCO2 during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2/HR during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2/HR during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in VO2/HR during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SpO2 during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SpO2 during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SpO2 during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SBP during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SBP during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SBP during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in DBP during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in DBP during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in DBP during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in MAP during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in MAP during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in MAP during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in HR during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in HR during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in HR during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SV during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SV during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SV during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in CO during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in CO during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in CO during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SVR during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SVR during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in SVR during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in EJT during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in EJT during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in EJT during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

Secondary Outcomes (6)

• Differences between MICE and HIIE protocol in heart rate variability (RMSSD and SD) during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in heart rate variability (RMSSD and SD) during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in heart rate variability (RMSSD and SD) during recovery

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in BRS during rest

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

• Differences between MICE and HIIE protocol in BRS during exercise

  The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.

Study Arms (2)

COPD Group A

EXPERIMENTAL

This group will perform moderate intensity continuous exercise in the 3rd visit and high intensity interval exercise in the 4th visit.

Other: Moderate intensity continuous aerobic exercise (MICE); Other: High-intensity interval aerobic exercise (HIIE)

COPD Group B

EXPERIMENTAL

This group will perform high intensity interval exercise in the 3rd visit and moderate intensity continuous exercise in the 4th visit.

Other: Moderate intensity continuous aerobic exercise (MICE); Other: High-intensity interval aerobic exercise (HIIE)

Interventions

Moderate intensity continuous aerobic exercise (MICE) OTHER

Patients will perform a moderate-intensity continuous aerobic exercise (MICE) protocol on a cycle ergometer that includes 20 minutes of cycling at 50%WRpeak.

COPD Group A; COPD Group B

High-intensity interval aerobic exercise (HIIE) OTHER

Patients will perform a high-intensity interval aerobic exercise (HIIE) protocol on a cycle ergometer that consists of 12 sets of 60 seconds work at 85% WRpeak followed by 60 seconds of rest.

COPD Group A; COPD Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD based on smoking history (pack/years) or exposure to other risk factors and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio \<0.7
• Resting arterial oxygen partial pressure at room air \>60 mmHg, according to recent (within a week) arterial blood gases assessment
• Disease being stable and treated optimal, based on current GOLD guidelines.
• Provision of informed written signed consent prior to study entry

You may not qualify if:

• Recent respiratory infection or exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), within the past 3 months
• Changes in COPD medication with the past month
• History of asthma and/or reversible airway obstruction (post bronchodilation FEV1/ FVC \>0.7)
• Pulmonary hypertension
• Congestive heart failure (Left Ventricle Ejection Fraction \<50% in recent echocardiography)
• Severe peripheral artery disease
• Chronic Kidney disease with eGFR \< 30 ml/min (KDIGO stages 3b, 4 ,5)
• Active acute or chronic infectious diseases
• Active malignant disease or hematologic disorder under treatment
• History of neuromuscular disorder
• History of severe intellectual disability or mental disorder
• Any contradiction to moderate-high intensity exercise or cardiopulmonary exercise testing according to ATS/ACCP guidelines, such as: myocardial infarction within the past 6 months, unstable angina, syncope, symptomatic severe aortic stenosis, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, severe untreated arterial hypertension at rest (\> 200 mm Hg systolic, \> 120 mm Hg diastolic blood pressure), orthopedic impairment that compromises exercise performance.

Sponsors & Collaborators

• George Papanicolaou Hospital: lead

Study Sites (1)

George Papanikolaou General Hoapital of Thessaloniki

Thessaloniki, Exohi, 57010, Greece

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

GR (1)