Improving Rehabilitation In Sarcopenia (IRIS)
- Conditions
- Sarcopenia
- Registration Number
- NCT03120026
- Lead Sponsor
- Azienda di Servizi alla Persona di Pavia
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- age 65 years or older
- admission for physical rehabilitation
- sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
- Mini Mental State Examination ≥18
- Informed consent
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- Indications related to the study product:
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.
- Known allergy to milk, milk products or other components of the proposed interventions
- Indication to or ongoing artificial nutrition support
- Inclusion in other nutrition intervention trials
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gait speed 8 weeks Change in gait speed (4-meter walking test)/month
- Secondary Outcome Measures
Name Time Method Functional status - ADL 8 weeks Change in activities of daily living (ADL) score
Functional status - handgrip strength 8 weeks Change in handgrip strength
Costs 8 weeks Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)
Physical performance - Timed Up and Go test 8 weeks Change in timed up and go test
Functional status - Barthel 8 weeks Change in Barthel index score
Body weight 8 weeks Change in body weight
Cognitive function - trail making test 8 weeks Change in trail making test
Physical performance - chair-stand 8 weeks chair-stand test
Quality of life 8 weeks Change in 12-item Short-Form Health Survey score (physical/mental components)
Cognitive function - Mini Mental State Examination 8 weeks Change in Mini Mental State Examination
Adverse events 8 weeks Difference in rate of adverse events related to gastrointestinal intolerance
Physical performance - Tinetti 8 weeks Change in Tinetti scale
Muscle mass 8 weeks Change in appendicular muscle mass
Trial Locations
- Locations (2)
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
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia🇮🇹Pavia, Italy