This study aims to evaluate exercise capacity and identify causes of Post-Exertional Symptom Exacerbation (PESE) in individuals with Long COVID. The investigators will compare the effectiveness of the Two-Day 6-Minute Incremental Step Test (6MIST) and the Cardiopulmonary Exercise Test (CPET) in detecting PESE. Additionally, the investigators will assess metabolism, mitochondrial function, autonomic symptoms, psychological factors, and physical activity. Participants will complete both the Two-Day 6MIST and the Two-Day CPET, with a one-month gap between them. Each test is performed on two consecutive days to assess the delayed symptom response. The subjective symptoms of PESE will also be measured through questionnaires. To explore potential causes of PESE, the investigators will measure metabolism using indirect calorimetry, bioelectrical impedance analysis and food diaries, mitochondrial dysfunction with NIRS technology, autonomic symptoms using the COMPASS-31 questionnaire, psychological factors with questionnaires and physical activity levels using an activity tracker. This study will determine if the Two-Day Step Test (6MIST) is a feasible alternative to the two-day CPET for measuring PESE and will help uncover underlying mechanisms contributing to symptom exacerbation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
25
This is a portable mask, which is connected to the SplendoHealth app. The Polar sens 10 heartrate monitor and TrainRed NIRS device are also connected to this app. The three devices (mask, heartrate monitor and NIRS) are measuring respiratory gases, heart rate and muscle tissue oxygenation simultanuously and at the end of the 6 min step test, you get an individual cardiorespiratory fitness report.
Golden standard for measuring PEM: the double cardio-pulmonary exercise test on a bike.
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel
Brussels, Jette, Belgium
Difference in oxygen uptake at peak (VO2 peak) between day 1 and day 2 measured with the CPET compared to measured with the Calibre device
The goal is to show that the Calibre device is a feasible alternative to the CPET.
Time frame: From day 1 and day 2 of experimental session 1 to day 1 and day 2 of experimental session 2, one month apart (±10 days)
Difference in Rate of Perceived Exertion (RPE) measured with the CPET compared to measured with the Calibre device
Rate of Perceived Exertion is measured with the Borg RPE Scale which is a subjective measurement instrument. The scores range from 6 to 20, in which 6 is equal to no exertion at all and 20 is maximal exertion.
Time frame: RPE will be measured during two experimental sessions, each with two days, one month apart. On day 1, RPE is recorded 15 minutes (±15 min) before and after the test. On day 2, RPE is measured 24 hours (±120 min) after test 1 and before test 2.]
Resting Energy Expenditure (kcal/kg/day), measured through Indirect Calorimetry (IC)
Measuring Resting Energy Expenditure as part of the Directed Acyclic Graph (DAG).
Time frame: Baseline (measured once, during the first study visit)
Total Energy Expenditure (TEE) in kcal/kg/day, measured through Indirect Calorimetry (IC)
Measuring Total Energy Expenditure as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Phase angle (degrees), measured through Bioelectrical Impedance Analysis (BIA)
Measuring Phase Angle as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Muscle mass (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)
Measuring muscle mass as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Fat mass index (kg/m2), measured through Bioelectrical Impedance Analysis (BIA)
Measuring fat mass index as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Fat-free mass index (kg/m²), measured through Bioelectrical Impedance Analysis (BIA)
Measuring fat free mass index as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Fat to fat-free mass ratio, measured through bioelectrical impedance analysis (BIA)
Measuring fat-free mass ratio as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Hydration (%), measured through Bioelectrical Impedance Analysis (BIA)
Measuring hydration as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Ratio of calorie and protein intake to individual need, measured through food diaries
Adequacy of feeding: the ratio between intake of calories and proteins and the individual need. Record of all food and drinks consumed over a 3-day period as part of the DAG.
Time frame: Between day 1 of study visit and day 1 of experimental session
Mean daily intake of calories, fats, proteins, and carbohydrates, measured through food diaries
Mean daily intake: calories, fats, proteins, carbohydrates Record of all food and drinks consumed over a 3-day period.
Time frame: Between day 1 of study visit and day 1 of experimental session
Oxygen availability as the partial pressure of oxygen (mitoPO2) (mmHg), measured through Near-infrared spectroscopy (NIRS)
Measuring oxygen availability as the partial pressure of oxygen as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) consists of 17 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater kinesiophobia. Measuring kinesiophobia as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Ability to bounce back after stressful events with the Brief Resilience Scale (BRS) Questionnaire
The Brief Resilience Scale (BRS) consists of 6 statements, each scored from 1 to 4, with 1 being 'strongly disagree' and 4 being 'strongly agree.' Higher scores indicate greater resilience. Measuring resilience as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Coping style with the Ways of Coping (WAYS) Questionnaire
Sixty-six statements about a stressful situation that participants experienced in the past week, for which they need to give a score ranging from 0 to 3, with 0 being "does not apply" or "not used," and 3 being "used a great deal". Measuring coping style as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Autonomic symptoms, measured with the COMPASS-31 questionnaire
Measuring autonomic symptoms as part of the DAG.
Time frame: Baseline (measured once during the first study visit)
Level of Physical Activity (PA) and sedentary behavior assessed by accelerometry (activity tracker)
Using an actigraph, with a frequenncy of 60 Hertz, that participants wear at their hip on their dominant side. Measuring physical activity as part of the DAG.
Time frame: During 7 days before the first experimental session
Change from Day 1 to Day 2 in Oxygen Uptake at First Ventilatory Threshold (VO₂ in ml/min/kg) during experimental session 1 or 2 (CPET)
Time frame: From Day 1 to Day 2 during experimental session 1 or 2 (CPET)
Change from Day 1 to Day 2 in Oxygen uptake at peak (VO2 in ml/min/kg) during experimental session 1 and 2 (CPET & 6MIST))
Time frame: From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)
Change from Day 1 to Day 2 in Workload (Watts) at first ventilatory threshold during experimental session 1 or 2 (CPET)
Time frame: From Day 1 to Day 2 during experimental session 1 or 2 (CPET)
Change from Day 1 to Day 2 in Workload (Watts) at peak during experimental session 1 or 2 (CPET)
Time frame: From Day 1 to Day 2 during experimental session 1 or 2 (CPET)
Change from Day 1 to Day 2 in Heart Rate (bpm) peak during experimental sessions 1 and 2 (CPET & 6MIST))
Time frame: From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST)
Change from Day 1 to Day 2 in Ventilation (VE) (Tidal Volume (TV) and Respiration Rate (RR)) during experimental sessions 1 and 2 (CPET 1 6MIST)
Time frame: From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST
Change from Day 1 to Day 2 in VE/VO2 slope during experimental sessions 1 and 2 (CPET and 6 MIST)
Time frame: From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST
Change from Day 1 to Day 2 in VO2/HR slope (= O2 pulse) during experimental sessions 1 and 2 (CPET and 6 MIST)
Time frame: From Day 1 to Day 2 during experimental sessions 1 and 2 (CPET & 6MIST
Change from Day 1 to Day 2 in Respiratory Exchange Ratio (RER) = VCO2/VO2 during experimental sessions 1 or 2 (CPET)
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Time frame: From Day 1 to Day 2 during experimental session 1 or 2 (CPET)
Change from Day 1 to Day 2 in Cardiorespiratory Optimal Point (COP) = VO2/VE during experimental session 1 or 2 (CPET)
Time frame: From Day 1 to Day 2 during experimental session 1 or 2 (CPET)