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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Product | Experimental | 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. |
|
| Isocaloric Placebo | Placebo Comparator | Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental product | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | Change in gait speed (4-meter walking test)/month | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical performance - Tinetti | Change in Tinetti scale | 8 weeks |
| Physical performance - Timed Up and Go test | Change in timed up and go test |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of care | Reduction in the level of intensity of care on a ordinal scale | 8 weeks |
| Type of discharge | Proportion of patients discharged at home |
Inclusion Criteria:
Exclusion Criteria:
More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli, MD, PhD | Azienda di Servizi alla Persona di Pavia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32961041 | Derived | Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Isocaloric placebo | Dietary Supplement | Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. |
|
| 8 weeks |
| Physical performance - chair-stand | chair-stand test | 8 weeks |
| Functional status - Barthel | Change in Barthel index score | 8 weeks |
| Functional status - ADL | Change in activities of daily living (ADL) score | 8 weeks |
| Functional status - handgrip strength | Change in handgrip strength | 8 weeks |
| Body weight | Change in body weight | 8 weeks |
| Muscle mass | Change in appendicular muscle mass | 8 weeks |
| Cognitive function - trail making test | Change in trail making test | 8 weeks |
| Cognitive function - Mini Mental State Examination | Change in Mini Mental State Examination | 8 weeks |
| Quality of life | Change in 12-item Short-Form Health Survey score (physical/mental components) | 8 weeks |
| Costs | Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures) | 8 weeks |
| Adverse events | Difference in rate of adverse events related to gastrointestinal intolerance | 8 weeks |
| 8 weeks |
| Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia | Pavia | 27100 | Italy |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |