Background
Cancer and aging
Sarcopenia and cachexia
Exercise training
Pancreatic, biliary tract and lung cancer
Aim
Hypothesis
Methods
Design
Participants
Patient involvement
Randomization
Intervention
Duration of exercise program | 12 weeks (24 sessions) |
Duration of exercise sessions | 60 min (10 min of warm-up, 45 min of PRT and 5 min of stretching) |
Exercise frequency | 2 times a week |
Rest period between exercise sessions | 2–5 days |
Warm-up | Exercises of light to moderate intensity with elements of balance and flexibility training (e.g. walking around in circles with changing directions, walking on toes and heels, floor touch, walking lunges, exercises on balance board) |
Description of PRT exercises | Chest press, abdominal crunch, leg press, leg curl (hamstrings), leg extension (quadriceps), lower back and low row |
No. of repetitions (PRT) | 15 RM (session 1–2), 12 RM (session 3–13), 10 RM (session 14–24) |
No. of sets per session (PRT) | 2 (session 1–6), 3 (session 7–24) |
Rest period between sets (PRT) | 60 s |
Controls
Study outcome measures
Physical tests
Feasibility measures
Patient-Reported Outcome Measures (PROM)
Physical activity
Qualitative assessment of participants’ experiences
Treatment tolerance and toxicity
Body measures
Inflammatory biomarkers
Hospital admissions
Mortality/survival
Time (week no.) | -2 to 0 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 17 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | ||||||||||||||||
Eligibility screen | X | |||||||||||||||
Informed consent | X | |||||||||||||||
Randomization | X | |||||||||||||||
Intervention | X---------------------------------------------------------------------------------------------------------------------------X | |||||||||||||||
Physical tests and examinations | ||||||||||||||||
30s-CST (primary outcome) | X | X | X | X | ||||||||||||
6MWT | X | X | X | X | ||||||||||||
Handgrip strength | X | X | X | X | ||||||||||||
Gait speed test | X | X | X | X | ||||||||||||
Physical activitya | X | X | ||||||||||||||
DXA | X | X | ||||||||||||||
BI | X | X | ||||||||||||||
Body weighta | X | X | X | X | ||||||||||||
Inflammatory biomarkers | X | X | X | X | ||||||||||||
PROMs | ||||||||||||||||
PRPS | X | X | X | X | ||||||||||||
MDASIa | X | X | X | X | ||||||||||||
EORTC-QLQ-C30 | X | X | X | X | ||||||||||||
HADS | X | X | X | X | ||||||||||||
Qualitative exploration | ||||||||||||||||
Individual Interviews | X | |||||||||||||||
Feasibility | ||||||||||||||||
Adherence | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Attrition | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Oncological treatment | ||||||||||||||||
Treatment related toxicityb | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Dose-reductionsb | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Hospitalizations | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Survival | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |