Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial

Table 3 Study assessment procedures and timetable

	Enrollment	Allocation	Intervention period								Follow-up period
Study week (W)	W-24 - W-4	W-4 - W0	Baseline	W1	W2	W4	W6	W8	W10	W12	W16^a	W20 ^a	W22^a	W24
Inclusion criteria, informed consent	✔		✔							✔				✔
SF-36^b and SarQoL^c QoL measures, Short FES-I^d, ADL^e, cognitive test battery^f, frailty^g			✔							✔				✔
SPPB^h, muscle strength (Biodex)ⁱ, muscle mass (BIA and DXA)^j, BMI^k			✔							✔				✔
Assess physical activity level^l		✔	✔	✔	✔	✔	✔	✔	✔				✔
Assess exercise compliance^l,m and MiniBESTest^n,m			✔	✔	✔	✔	✔	✔	✔	✔
Falls, use of health care			✔	✔		✔		✔		✔	✔	✔	✔	✔
MNA-SF^o			✔				✔			✔				✔
Analyses food diaries		✔		✔		✔				✔				✔
(Dis) advantages of interventions assessment				✔		✔		✔		✔	✔	✔	✔	✔
Blood sample	✔	✔	✔	✔		✔	✔			✔				✔
Urine collection (24 h)			✔	✔	✔	✔	✔	✔	✔	✔				✔
Muscle sample			✔							✔

^a: telephonic visit; ^b: SF-36: health related quality of life scale questionnaire [41]; ^c: SarQol questionnaire [42]; ^d: Short FES-I: falls efficacy scale international [43]; ^e: ADL: activities of daily living according to Barthel index [44]; ^f: cognitive test battery consisting of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [45], Trail-Making Test, parts A and B [46], Maze test and Stroop test [47]; ^g: frailty defined by Fried; ^h: SPPB: short physical performance battery [25]; ⁱ: muscle strength by biodex; ^j: muscle mass by bioelectrical impedance analysis (BIA) and dual-energy x-ray absorptiometry (DXA); ^k: BMI: body mass index; ^l: compliance and physical activity measured by movement monitor; ^m: only participants randomized into exercise group; ⁿ: MiniBESTest [32]; ^o: MNA-SF: mini nutritional assessment short form [27]

ISSN: 1471-2318