This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Pavia, Italy
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
Pavia, Italy
Gait speed
Change in gait speed (4-meter walking test)/month
Time frame: 8 weeks
Physical performance - Tinetti
Change in Tinetti scale
Time frame: 8 weeks
Physical performance - Timed Up and Go test
Change in timed up and go test
Time frame: 8 weeks
Physical performance - chair-stand
chair-stand test
Time frame: 8 weeks
Functional status - Barthel
Change in Barthel index score
Time frame: 8 weeks
Functional status - ADL
Change in activities of daily living (ADL) score
Time frame: 8 weeks
Functional status - handgrip strength
Change in handgrip strength
Time frame: 8 weeks
Body weight
Change in body weight
Time frame: 8 weeks
Muscle mass
Change in appendicular muscle mass
Time frame: 8 weeks
Cognitive function - trail making test
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in trail making test
Time frame: 8 weeks
Cognitive function - Mini Mental State Examination
Change in Mini Mental State Examination
Time frame: 8 weeks
Quality of life
Change in 12-item Short-Form Health Survey score (physical/mental components)
Time frame: 8 weeks
Costs
Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)
Time frame: 8 weeks
Adverse events
Difference in rate of adverse events related to gastrointestinal intolerance
Time frame: 8 weeks