Effectiveness of an intervention in multicomponent exercise in primary care to improve frailty parameters in patients over 70 years of age (MEFAP-project), a randomised clinical trial: rationale and study design

Table 1 Schedule of enrollment, interventions, and assessments in MEFAP Project

TIMEPOINT	Enrolment	Allocation				End of Study
TIMEPOINT	-t ₁	0	t _{1 baseline}	Intervention	t ₂ 6 –months post-intervention	t ₃ 12–months post-intervention
ENROLMENT
Eligibility screen	X
Informed consent	X
Randomized Allocation		X
INTERVENTION
INTERVENTION GROUP: Multicomponent Exercise Program (MEFAP)				X
CONTROL GROUP: Regular Clinical Practice				X
ASSESSMENTS
*Main outcome variables:*
● Frailty level (Fried Criteria)	X		X		X	X
Secondary outcome variables
● Function-related variables: SPPB, risk of falls			X		X	X
● Quality of life			X			X
● Clinical Parameters:
✓ Blood pressure			X		X	X
✓ BMI			X		X	X
✓ Cognitive state (MEC30 Lobo)			X		X	X
✓ Mood (Yesavage test)			X		X	X
✓ Chronic-use drugs (last 2 weeks).			X		X	X
✓ Chronic pain
● Analytical Parameters (metabolic and inflammation).					X	X
● Program adherence and satisfaction level			X			X
Independent Variables
● Sociodemographic			X
● Comorbidity o diagnosis of ≥ 2 chronic disease			X
● Fracture in previous 5 years			X

MEFAP: Multicomponent physical activity program (for its acronym in Spanish), SPPB short physical performance battery, BMI Body Mass Index, MEC30 Lobo Mini-mental Exam Cognitive (Translated and adapted to Spanish by Lobo et al. 2002 [33])

ISSN: 1471-2318