Physical Activity Clinical Trial
Official title:
Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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