Sarcopenia
Conditions
Brief summary
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure
Interventions
OTHERMediterranean diet
Mediterranean diet recommendations and daily physical exercise
DIETARY_SUPPLEMENTHypercaloric, hyperproteic oral nutritional supplement
Hypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise
DIETARY_SUPPLEMENTProtein module
Protein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise
COMBINATION_PRODUCTVitamin D supplementation
Calcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml)
COMBINATION_PRODUCTPhysical exercise
Physical exercise adapted to patients with heart failure (Cardiac rehabilitation)
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a previous admission due to HF in the previous 12 months * Moderate or severe LVEF * Both sexs * Age \>18 years old.
Exclusion criteria
* MDRD \<15 ml/min * End-stage liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | 6 months | Changes in muscle mass |
| Functionality | 6 months | Changes in functionality determined by the up and go test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Albumin | 6 months | Changes in serum albumin levels (g/dl) |
| C-RP | 6 months | Changes in serum C-RP (g/dl) |
Countries
Spain
Outcome results
None listed