Table 3.
Tabulated summary of trial schedule.
| Outcomes | Instrument | T0 | T1 | T2 | T3 |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Exercise capacity | Peak oxygen uptake via cardiopulmonary exercise test on cycle ergometer | X | X | X | X |
| Secondary outcomes | |||||
| Physical activity | ActiGraph GT9X Link | X | X | X | X |
| Health related physical fitness | |||||
| Body morphology/composition | Body mass (body weight scale), height (stadiometer)and waist circumference (stretch-resistant measuring tape). Bioelectrical impedance will be used to assess fat and fat-free mass. | X | X | X | X |
| Handgrip strength | Isometric handgrip grip strength of both hands using a Jamar Hydraulic Hand Dynamometer (Sammons Preston Inc.). | X | X | X | X |
| Quadriceps muscle strength | Three voluntary maximal isometric contractions (6 s) performed at a 60° angle of the knee, with a 60-second rest period between each test, on a dynamometer (Biodex Medical Systems Inc., 840–000 System 4, New York, USA). | X | X | X | X |
| Quadriceps muscle endurance | 25 repetitive maximal isokinetic knee extensions at 180°/s, performed on a dynamometer. Mean torque and percentage decrement score will be used as markers for muscle endurance. | X | X | X | X |
| Cardiovascular health | |||||
| Blood sampling | Glucose homeostasis, blood lipid profile, NT-proBNP | X | X | X | |
| Rest and stress echocardiography | Vivid E95 ultrasound scanner, semi-supine bicycle ergometer (Ergoline) is used for stress echocardiography. | X | X | X | |
| Health related QoL & psychosocial wellbeing | EQ-5D-5l Questionnaire | X | X | X | X |
| SF-36 Questionnaire | X | X | X | X | |
| Exercise Self-Efficacy Scale | X | X | X | X | |
| Exercise Barriers Questionnaire | X | X | X | X | |
| Social Support Questionnaire | X | X | X | ||
| Implementation potential | User experience Questionnaire | X | |||
| Adherence to exercise program | X | ||||
| Patient Debriefs: Self-reported and objective measures (exercise log, heart rate measurements) | X | ||||
| Evaluation towards cost-effectiveness | Productivity Cost Questionnaire | X | X | X | X |
| Medical Consumption Questionnaire | X | X | X | X | |
| Quality of life via EQ-5D-5l questionnaire | X | X | X | X | |
| Safety monitoring | Adverse events reporting by patients | X——————––X | |||
| Other outcomes | |||||
| Sociodemographic characteristics | General Questionnaire | X | X | X | X |
| Substudy: muscle metabolism | Device for muscle oxygenation measurements (PortaMon) | X | X | ||
| Substudy: vasoreactivity/vasomotor function | Flow mediated slowing via Vicorder | X | X | ||
T0, baseline; T1, measurement at 4 months; T2, measurements at 1 year; T3 measurements at 2 years; NIRS, near infrared spectroscopy; FMS, flow mediated slowing.