High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

Study Overview
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Brief Summary
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Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.

Detailed Description
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12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols. Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.

Official Title
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High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

Conditions
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COPD

Intervention / Treatment
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* Other: High intensity interval training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18-80 years Moderate to severe COPD(GOLD stage II to III) Exclusion Criteria: Known ischaemic heart disease Known heart failure Previous or current coronavirus disease 2019 (COVID-19) Dementia or other severe neurological disease Known vascular Symptoms of disease within 2 weeks prior to the study Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4*4 followed by 10*1 or 10*1 followed by 4*4<br>Following baseline measurements, participants are allocated to the random sequence, by which they will complete the two HIIT protocols ⟨http://www.randomization.com⟩ and based on this, patients are randomized to a specific testing sequence. | Other: High intensity interval training<br>* Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise feasibility: Relative dose intensity (RDI) of exercise | RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100 Evaluated with a Red-Amber-Green system: Green: If ≥85% of the training is completed Amber: If 50-85% of the training is completed Red: If ≤ 50% of the training is completed | 1 week | 
| Exercise feasibility: Exercise sessions requiring dose modifications | Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise. | 1 week | 
| Exercise tolerability: Subjective rating of the exercise session | Tolerability is measured with a 10-point Likert scale, where the participants evaluate the two HIIT protocols. They will anser two quesitens: How tolerable was todays traning? How much did you enjoy todays training? Where 1 means not at all, and 10 means alot. The Likert scale is scored as: Red: 1-2 Amber: 3-4 Green: +5 | 1 week | 
| Exercise feasibility: Exercise sessions attendance rate | Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100 | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIIT, COPD