Sarcopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age over 65 years; Gender: female and male 3) Sarcopenia according to the diagnostic criteria of EWGSOP2: Sarc-F questionnaire: score greater than or equal to 6; Handgrip test (grip strength): men under 27kg, women under 16kg or Stand up / sit test: more than 15 seconds for 5 climbs; skeletal musAgecle mass: men less than 20kg, women less than 15kg or skeletal muscle mass / height2: men less than 7.0 kg / m2; women less than 5.5 kg / m2 - SPPB tests: score greater than 8; Sedentary lifestyle; Independent in relation to activities of daily living (score greater than or equal to 46 on the modified Barthel index) Rely on support persons (family members or external staff) to assist in following the diet and study recommendations; Having provided written consent to participate in the study, confirmed by signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: Creatinine clearance less than 35 mL / min; Use of nasogastric tube or gastrostomy; Bedridden patients; Parkinson's disease; Type 1 diabetes, chronic kidney disease; Severe heart diseases; Other clinical conditions that may, according to medical criteria, make physical exercise and / or food supplementation unfeasible with FortiFit PRO®; Vitamin D level less than 20ng / ml at the end of the run-in period; BMI greater than or equal 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased strength in independent elderly diagnosed with sarcopenia after 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement of muscle mass assessed through DXA; ;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement of physical performance through SPPB;;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise:Improvement in the level of physical activity;;After 12 weeks of intervention with FortiFit PRO® supplement associated with physical exercise: Improvement in the quality of life. | — |
Countries
Brazil
Contacts
Ibramep - Instituto Brasileiro de Medicina e PEsquisa