Continuous Versus High Intensity Interval Exercise in Chronic Obstructive Pulmonary Disease

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGeorge Papanicolaou Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Moderate intensity continuous aerobic exercise (MICE)

    Other intervention

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

  • High-intensity interval aerobic exercise (HIIE)

    Other intervention

    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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: COPD Group AExperimental treatment 2 interventions
Group B: COPD Group BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

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

Time frame
The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.
3

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

Time frame
The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.
4

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

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

Secondary outcomes

1

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

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

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

Time frame
The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.
3

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

Time frame
The MICE and HIIE protocols will be conducted within 2 weeks from enrollment and will be separated by one week.
4

Differences between MICE and HIIE protocol in BRS during rest

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

Other outcomes

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