Effects of β-hydroxy-β-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol

Table 2 Schedule of enrollment, interventions, and assessments

TIMEPOINT	Enrollment -t₁	Allocation 0	Baseline t₁	Intervention	Follow-up 12th week post baseline t₂	Close-out 25th week post baseline t₃
ENROLLMENT
Eligibility screen	✓
Informed consent	✓
Randomized Allocation		✓
INTERVENTION				✓
Ex-HMB				✓
NoEx-HMB				✓
Ex-Plac				✓
Control				✓
ASSESSMENTS
Functional capacity (primary outcome)
SPPB: Gait speed, balance, and 5-sit-to-stand	✓		✓		✓	✓
Muscle strength and power
Grip strength			✓		✓	✓
1RM seated leg press			✓		✓	✓
1RM vertical bench press			✓		✓	✓
Sit-to-stand muscle power			✓		✓	✓
Frailty and fall risk
Frailty phenotype			✓		✓	✓
Falls history	✓		✓		✓	✓
Fall risk assessment	✓		✓		✓	✓
Body composition			✓			✓
Blood pressure and resting heart rate			✓		✓	✓
Haematology			✓		✓	✓
Biochemical analyses			✓		✓	✓
Nutritional status			✓		✓	✓
Sarcopenia			✓		✓	✓
Disability and comorbidity
Barthel index			✓		✓	✓
Lawton index			✓		✓	✓
Comorbidity			✓		✓	✓
Cognitive function	✓		✓		✓	✓
Depression			✓		✓	✓

Ex: 12-week of VIVIFRAIL multicomponent exercise program. HMB: dietary supplementation of HMB. Plac Placebo. SPPB Short Physical Performance Battery; 1RM one-repetition maximum

ISSN: 1471-2318