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Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.
The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.
These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.
In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in.
General objective:
To assess the effectiveness and safety of a multimodal and multidisciplinary intervention in the prevention of sarcopenia, frailty and functional decline in pre-frail community elders aged 70 years or older.
Specific objectives:
Evaluate the effect of the study intervention in the medium term (1 year) in terms of prevention or improvement of:
To evaluate the safety of the mid-term study intervention (1 year) in pre-frail community elders aged 70 years or older.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual clinical practice | |
| Intervention | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Mass | Bioimpedance | baseline, 6 months and 12 months |
| Muscle strength and/or Muscle function | Isokinetic | baseline, 6 months and 12 months |
| Sarcopenia | EWGSOP2 description | baseline, 6 months and 12 months |
| Frailty | L Fried Criteria | baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity 1 | Barthel index | baseline, 6 months and 12 months |
| Functional Capacity 2 | Lawton index | baseline, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mateu Serra-Prat, MD PhD | FundaciĂ³ Privada Salut del Consorci Sanitari del Maresme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari del Maresme | MatarĂ³ | Barcelona | 08304 | Spain | ||
| Mateu Serra-Prat |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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|
| Functional Capacity 3 | Timed up and go test | baseline, 6 months and 12 months |
| Functional Capacity 4 | SPPB | baseline, 6 months and 12 months |
| Functional Capacity 5 | Unipodal test | baseline, 6 months and 12 months |
| Functional Capacity 6 | Walking speed mesured by looking time to walk 4.6 meters | baseline, 6 months and 12 months |
| MatarĂ³ |
| Barcelona |
| 08304 |
| Spain |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |