Table 2.
Tools, parameters and timing of the study measurements
| Assessment tool | Parameter | Assessment periods |
| Differential changes in blood parameters (sample taken from the antecubital vein) | ||
| Electrochemiluminescence immunoassay | 25(OH)D (nmol/L). | 0M, 3M, 6M, 12M |
| Photometry—NM-BAPTA | Calcium (mmol/L). | 0M, 3M, 6M, 12M |
| Potentiometry with ion-selective electrodes | Ionised calcium (mmol/L). | 0M, 3M, 6M, 12M |
| Chemiluminescence immunoassay (CLIA) | Parathyroid hormone (ng/L). | 0M, 3M, 6M, 12M |
| Photometry—molybdate ultraviolet | Phosphate (mmol/L). | 0M, 3M, 6M, 12M |
| Photometry—particle-enhanced turbidimetric immunoassay | Cystatin C (mg/L). | 0M, 3M, 6M, 12M |
| Estimated from cystatin C following CKD-EPI and Grubb | Estimated glomerular filtration rate (mL/min). | 0M, 3M, 6M, 12M |
| CLIA | Testosterone (ng/dL). | 0M, 3M, 6M, 12M |
| Differential changes in personal characteristics | ||
| Body mass index | From weight and height (kg/m²). | 0M, 3M, 6M, 12M |
| Sun exposure based on Hanwell et al 47 | Time spent outdoors (min) with level of exposed skin.* | 0M, 3M, 6M, 12M |
| Physical activity | Sport per week (hours and frequency). | 0M, 3M, 6M, 12M |
| Medication and supplements | Sort and dosage (supplements only). | 0M, 3M, 6M, 12M |
| Further illnesses | Incidence since last measurement. | 0M, 3M, 6M, 12M |
| Skin phototype on the posterior forearm based on Fitzpatrick48 | Six categories ranging from light to very dark skin types. | Screening |
| SCI characteristics | Time since SCI (years), neurological level of injury,49 the degree of impairment following the American Spinal Injury Association Impairment Scale.49 | Screening |
| Differential changes in bone mineral density | ||
| X-ray densitometry, Lunar iDXA Serie with enCORE V.17 Software | T-scores for the forearm (radius), hip (femoral neck) and knee (distal femur and proximal tibia). | 0M, 12M |
| Differential changes in functional independence | ||
| Spinal Cord Independence Measure III50 | Self-care subscore (0–20), respiration and sphincter management subscore (0–40), indoor mobility subscore (0–10), outdoor mobility subscore (0–30), total score (0–100). | 0M, 3M, 6M, 12M |
| Differential changes in urinary tract infections | ||
| Exact questions of the first-wave questionnaire of the Swiss Spinal Cord Injury (SwiSCI) survey27 51 | Incidence since the last measurement, medical care required. | 0M, 3M, 6M, 12M |
| Differential changes in pressure injuries | ||
| Exact questions of the first-wave questionnaire of the SwiSCI survey27 51 | Localisation and grade following the European and United States National Pressure Ulcer Advisory panels classification.52 | 0M, 3M, 6M, 12M |
| Differential changes in pain | ||
| Exact questions of the first-wave and second-wave questionnaire of the SwisSCI survey,27 51 based on the International SCI Pain Basic Data Set53 as well as the SCI Secondary Conditions Scale54 | The occurrence, kind, location and influence of pain during the last week as well as chronic pain (>3 months). | 0M, 3M, 6M, 12M |
| Differential changes in strength | ||
| Jamar Smart Hand Dynamometer (Patterson Medical, Warrenville, Illinois) | Three measurements of the left and right hand (mean kg). | 0M, 3M, 6M, 12M |
| Differential changes in mood | ||
| Hospital Anxiety and Depression Scale55 | Total score (14–56). | 0M, 3M, 6M, 12M |
| Differential changes in fatigue | ||
| Fatigue Severity Scale56 | Total score (9–63). | 0M, 3M, 6M, 12M |
| Differential changes in falls | ||
| Occurrence | Incidence since last measurement, reason daily activity, sport or accident) and medical care required. | 0M, 3M, 6M, 12M |
| Safety of the investigational medical products | ||
| Serious adverse events | The occurrence of life-threatening medical complications, the requirement of hospitalisation. | Any time |
| Side effects, tolerability and adherence | Number of and reason for missed intake, side effects. | 0M, 3M, 6M, 12M |
Assessment periods are referenced to the date of the first visit (0M) and include screening (screening; max 30 days before 0M), 3-month follow-up (3M; 90±7 days), 6-month follow-up (6M; 180±7 days) and 12-month follow-up (12M; 365±7 days). Serious adverse events are continuously evaluated.
*Level of exposed skin: (1) hands and face, (2) hands, face and arms, (3) hands, face and legs, (4) entire body (bathing suit).
CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; NM-BAPTA, 5-nitro-5′-methyl-(1,2-bis(o-aminophenoxy)ethane-N, N, N′, N′-tetraacetic acid); SCI, spinal cord injury.