Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure: proposed schedule for enrolment, intervention, and assessment

Time point		Study period
	Enrolment	Stabilization phase	Allocation	Post-allocation			Close-out
	t₁	t₂	t₃	t₃	t₄	t₅	t₅
Enrolment
Eligibility screen	X
Informed consent	X
Medical screening			x
Nutrition check	x	x			x
Allocation			x
Interventions*
*[EXEPROT]*				↔	↔	↔
*[PROT]*				↔	↔	↔
*[REC]*					x	x
Assessments
[Baseline variables, gender, age, education, marital status, depression, incontinence, chronic diseases, use of medication, risk of poor protein intake, eating symptom questionnaire, risk of dysphagia, appetite, dental status]				X
*[primary outcome variable lower leg muscle power]*				x		x	X
[secondary outcome variables physical frailty status, jump muscle power, leg press, hand grip strength, SPPB, waist and hip circumference, body weight, lean mass, fat mass, BMD, health-related QoL, pain, fatigue, ADL, fear of falling, blood markers, physical activity, sedentary behavior, nap and sleep, dietary intake, walking speed, rising from laying position, MNA, EVS, risk of poor protein intake, DDST]				x		x	x

DSST Digit Symbol Substitution Test, SPPB Short Physical Performance Battery, BMD bone mineral density, QoL quality of life, ADL activities of daily living, MNA Mini Nutritional Assessment, EVS Eating Validation Scheme
*See explanation in the text

ISSN: 1745-6215