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| Name | Class |
|---|---|
| University of Valencia | OTHER |
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Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it is not known physical training pattern more beneficial for these patients. The reasons for heterogeneity and lack of consistency of the results described by published intervention programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings - or a combination of them. There are no studies with a combined program of this three kinds of physical training.
The objective of this study is to know if a multicomponent physical training program during 180 days in dwelling-community frail geriatric patients can improve scores on functional, activities of daily living, mood, cognitive and quality of life scales and producing changes in blood levels of biological and genetic markers.
At the start of recruitment, a comprehensive geriatric assessment will be developed in enrolled patients of both groups. After this assessment and before starting the physical training in intervention group, a nutritional intervention will be provided in patients of both groups :
Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.
As well as, calcium and vitamin D will be provided if calcidiol blood levels are lower than 30 ng/ml.
Calcidiol blood value between 20-29 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 15 days (3 months)
Calcidiol blood value between 10-19 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 10 days (3 months)
Calcidiol blood value between 1-9 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 7 days (3 months)
After nutritional intervention, intervention group will start a multicomponent training intervention during 180 days Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)
Legend:
min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% HRmax c = Strength training arms and legs d = Stretching Characteristics of the strength training Month 1 Week 1 25% 1-RM 1x30 r Week 2 25% 1-RM 2x30 r Week 3-4 25% 1-RM 3x30 r Month 2 Week 1-4 25% 1-RM 3x30 r Month 3 Week 1 50% 1-RM 1x15 r Week 2 50% 1-RM 2x10 r Week 3-4 50% 1-RM 3x8 r Month 4 Week 1-4 50% 1-RM 3x8 r Month 5 Week 1 75% 1-RM 1x15 r Week 2 75% 1-RM 2x10 r Week 3-4 75% 1-RM 3x8 r Month 6 Week 1-4 75% 1-RM 3x8 r
Legend:
1-RM: One-repetition maximum r: repetitions
Monthly, enrolled frail elderly patients will be evaluated. 6 minutes walking test, timed up and go test, bilateral hand grip, Barthel index, Tinetti balance assessment tool, Mini-mental state examination, short-MNA (Mini Nutritional Assessment ), lean and fat mass measures with impedanciometer and number of visits to general practitioner, emergency room and hospital admission were recorded.
After follow up period a new comprehensive geriatric assessment will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Multicomponent training intervention : 3 sessions a week of 45 minutes of resistance activity (24 weeks) 2 sessions a week of 45 minutes of strength training (24 weeks) 5 sessions a week of 15 minutes of proprioceptive training (24 weeks) |
|
| Control group | Placebo Comparator | Normal routine during 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent training intervention | Other | Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d) Legend: min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% maximal Heart rate c = Strength training arms and legs d = Stretching |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of daily living. | The primary study endpoint is the change from baseline to the end of the intervention, and the change between the intervention group and the control group, in score of Barthel Activities of Daily Living Index and the Lawton Instrumental Activities of Daily Living Scale | Day 0 and Day 180 (plus or minus 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination (MMSE) | Change from baseline to the end of the intervention, and the change between the intervention group and the control group. | Day 0 and Day 180 (plus or minus 3 days) |
| Short Physical Performance Battery and Physical Performance Test |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Depression Scale | Change from baseline to the end of the intervention, and the change between the intervention group and the control group. | Day 0 and Day 180 (plus or minus 3 days) |
| Quality of life: EuroQol-5D |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Pérez-Ros, PhD | Catholic University of Valencia San Vicente Mártir | Study Chair |
| Francisco Martínez-Arnau, PhD | University of Valencia | Study Chair |
| Jose Vina, MD,PhD | Univeristy of Valencia | Study Director |
| Carmen Gómez-Cabrera, PhD | University of Valencia | Study Chair |
| Francisco J Tarazona-Santabalbina, MD, PhD | Hospital de la Ribera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de la Ribera | Alzira | Valéncia | 46600 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26947059 | Derived | Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nutritional intervention | Other | Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight. Calcium plus vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) Vitamin D will be provided if calcidiol (Cldl) blood levels are lower than 30 ng/ml. Cldl 20-29 ng/dl it will provide calciferol 20.000 IU every 15 days (3 months) Cldl 10-19 ng/dl it will provide calciferol 20.000 IU every 10 days (3 months) Cldl 1-9 ng/dl it will provide calciferol 20.000 IU every 7 days (3 months) |
|
Change from baseline to the end of the intervention, and the change between the intervention group and the control group. |
| Day 0 and Day 180 (plus or minus 3 days) |
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
| Day 0 and Day 180 (plus or minus 3 days) |
| Composite effect of a multicomponent training intervention on systemic biomarkers of frailty |
| Day 0 and Day 180 (plus or minus 3 days) |