Table 2 Schedule of enrolment, interventions and assessments
Visit | 1 | 2 | 3 |
|---|---|---|---|
Timeline | Day 1 | 3 months (+6weeks) | E-linkage |
Trial Activity Setting | Enrolment Hospitalised, non-hospitalised COVID-19 | Outcome evaluation CRF | 1 and 10 years |
Screening – inclusion/exclusion criteria including DASI questionnaire | √ | ||
Written informed consent | √ | ||
General health status check | √ | ||
Medical history/clinical status2 | √ | √ | |
Vital signs (heart rate, rhythm, BP, height, weight, waist circumference, oxygen saturation, at baseline and during follow-up) | √ | √ | |
Cardiovascular risk factors, risk score | √ | √ | |
Routine blood samples as per standard of care | √ | √ | |
Spirometry | √ | √ | |
Handgrip strength | √ | √ | |
Short Physical Performance Battery (SPPB) | √ | √ | |
Accelerometer (Glasgow only) | √ | √ | |
PROMS including EQ5D, PHQ, Illness perception (Brief IPQ), Duke Activity Status Index (DASI), International Physical Activity Questionnaire (IPAQ-SF) short-form, Fatigue questionnaires | √ | √ | |
Frailty 1) Fried 5-criteria phenotype, 2) Clinical Frailty Scale | √ | √ | |
Training - Hospital, CRF, on-line, telephone | |||
Randomisation | √ | ||
Training (resistance exercise) | √ | ||
Incremental shuttle walk test (ISWT) | √ | √ | |
Exercise dose (log, level, adherence) | √ | √ | |
Episodes of care (primary, secondary, physiotherapy, rehabilitation) | √ | √ | |
Research blood sample | √ | ||
Gluteal Biopsy (optional vascular biology sub-study) | √ | ||
Data collection – clinical endpoints (collected via hospital Portal/Trakcare systems) and e-record linkage | √ |