Table 2.
Control arm | Intervention arm | |||||||
---|---|---|---|---|---|---|---|---|
Sessions | Time pointa | T1 | T2/T3 | T4 | T1 | T2/T3 | T4 | |
Detail of assessment/intervention | ||||||||
Nutritional sessions 30 min at T1 20 min at T2, T3, and T4 |
Assessments | •Food intake | ○ | – | ○ | ○ | ○ | ○ |
• Nutritional status (MNAd) | ○ | – | ○ | ○ | ○ | ○ | ||
• Nutritional checklistb | ○ | – | ○ | ○ | ○ | ○ | ||
•Skeletal muscle analysis | ○ | – | ○ | ○ | – | ○ | ||
•Diet diary collection | – | – | – | – | ○ | ○ | ||
Interventions | • Nutritional advice | – | – | – | ○ | ○ | ○ | |
• Support for NISd management, food environment, and eating-related distress | – | – | – | ○ | ○ | ○ | ||
• ONSd prescriptionc | – | – | – | ○ | ○ | – | ||
Exercise session 30 min at T1 20 min at T2, T3, and T4 each for A and B. |
Assessments | • Assessment of physical function (Hand-grip strength, SPPBd) | ○ | – | ○ | ○ | – | ○ |
• Exercise diary collection | – | – | – | – | ○ | ○ | ||
• Assessment of physical activity (Physical activity measurement, Physical activity interview) |
○ | – | – | ○ | ○ | ○ | ||
• EORTC-QLQ-C30 questionnaire | ○ | – | ○ | ○ | – | ○ | ||
Interventions | A. Home-based resistance training | |||||||
• Prescription (T1) and modification (T2, T3, T4) of exercise program | – | – | – | ○ | ○ | ○ | ||
• Instruction of exercise procedures | – | – | – | ○ | ○ | ○ | ||
•Education of self-modification | – | – | – | ○ | ○ | ○ | ||
B. Physical activity promotive counseling | ||||||||
• Prescription of target daily step | – | – | – | ○ | ○ | ○ | ||
• Physical activity counseling | – | – | – | ○ | ○ | ○ | ||
• Education of fall prevention | – | – | – | ○ | ○ | ○ |
aBaseline assessments were performed during the time between study entry and initiation of chemotherapy (T1 point). Subsequent assessments were at 4 ± 2 (T2 point), 8 ± 2 (T3 point), 12 ± 2 (T4 point) weeks after the study enrollment
bNutritional checklist to collects information about presence or absence of nutrition impact symptoms, problems in food environment, or eating-related distress
cA branched-chain amino-acids rich oral nutritional supplement (Inner Power®, Otsuka Pharmaceutical Co., Ltd., Japan) was provided one pack daily for 12 weeks
dMNA Mini-nutritional assessment, NIS nutrition impact symptoms, ONS oral nutritional supplement, SPPB Short Physical Performance Battery