Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Participants who met inclusion criteria will be randomized to control (usual care)l or intervention group (multicomponent exercise program). The main objective of the trial is to study the effect of a multicomponent exercise training program (resistance, aerobic, strength, balance and flexibility) in frail aged participants who live in the community with cognitive decline in: functional capacity, strength, power, cognition, falls , depression, quality of life, institutionalization and hospital admissions
Usual care group (control) Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed. Intervention group (training) The intervention will consist of a multicomponent exercise training programme -VIVIFRAIL-(A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70, Showed in www.vivifrail.com), which will be composed of supervised progressive resistance training, balance-training, flexibility and cardiovascular for 7 days/week. During the training period, patients will be trained between 2 and 120 minutes each day. The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1RM combined with balance-training, flexibility and gait exercises that progressed in difficulty. The resistance exercises focused on the major upper and lower limb muscles. During the progressive resistance training, instruction will be provided to the participants to perform the exercises at a high velocity of motion. However, care will be taken to ensure that exercises were executed with correct form. Balance and gait training exercises that progressed in difficulty will be also implemented: e.g. semitandem foot standing, line walking, stepping practice, walking with small obstacles, proprioceptive exercises, and altering the base of support and weight transfer from one leg to the other. An experienced physical trainer will carefully explain all the exercises. Participants and their carer / family members will be carefully familiarized with the training procedures in advance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty.
Fundación Miguel Servet/ Navarrabiomed
Pamplona, Spain
RECRUITINGShort Physical Performance Battery (SPPB)
The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB) which evaluates, balance, gait ability, and leg strength using a single tool. The total score ranges from 0 (worst) to 12 points (best). The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization, and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A one-point change in the score has clinical relevance
Time frame: Changes from baseline to 1st and 3th months of follow up
Barthel index
international and validated tool of disability. The score range from 0 (severe functional dependence) to 100 (functional independence
Time frame: Changes from baseline to 1st and 3th months of follow up
Handgrip strength in the dominant hand
Loss of handgrip strength in the dominant hand evaluated with a dynamometer is a useful tool for the measurement of functional capacity. This characteristic is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Higher values indicates better function Ranges of normality are corrected by BMI. For example for men with a BMI less of 24 , normality is consider over 29 kg
Time frame: Changes from baseline to 1st and 3th months of follow up
6-metre gait velocity test (GVT).
Gait ability will be assessed using the 6-metre gait velocity test (GVT). Starting and ending limits will be marked on the floor with tapelines for a total distance of 8 meters. Participants will be instructed to walk in their self-selected usual pace for two attempts. The best result of both trials will be registered. The first and last metre, considered the warm-up and deceleration phases, respectively, will not be included in calculations of the gait assessment. Higher scores ( \> 1.0 m/s) indicates better functional capacity and lower scores (\< 0.8 m/s) scores worse functional capacity
Time frame: Changes from baseline to 1st and 3th months of follow up
MEC-Lobo cognitive test
cognitive function will be measured will the Spanish Version of MMSE ( MEC-Lobo) in case of dementia. It ranges from 0 ( worse score ) to 35 (best score). A score less than 23 indicates significative cognitive decline
Time frame: Changes form baseline to 1st and 3th months of follow up
MOCA( Montreal Cognitive Assessment) test
cognitive function will be measured with MOCA ( Montreal Cognitive Assessment Test) in case of mild cognitive decline. The MOCA is a validated test in Spanish It ranges from 0 ( worse score ) to 30 (best score). A score less than 26 indicates suggest mild cognitive decline
Time frame: Changes from baseline to 1st and 3th months of follow up
Trail Making Test part A ( TMT-A)
Executive function will be assessed with the Trail Making Test part A. Results for TMT A are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.Average will be consider 29 seconds, Deficient \> 78 seconds and Rule of Thumb most 90 seconds.
Time frame: Changes from baseline to 1st and 3th months of follow up
Isometric lower limb strength test (right knee extensors and hip flexors)
Isometric lower limb (right knee extensors and hip flexors) muscle strength will be measured using a manual dynamometer. Higher values indicates better functional capacity
Time frame: Changes from baseline to 1st and 3th months of follow up
1Repetition Maximum (RM) Maximal dynamic strength test
Maximal dynamic strength will be assessed using the 1Repetition Maximum (RM) test in the bilateral leg press exercise using exercise machines (Exercycle, S.L., BH Group, Vitoria, Spain). In the first assessment, the subjects will warm up with specific movements for the exercise test. Each subject's maximal load will be determined in no more than five attempts, with a 3-min recovery period between attempts.
Time frame: Changes from baseline to 1st and 3th months of follow up
Repetitions at maximal velocity at intensities of 50% of 1RM test
Participants will perform ten repetitions at maximal velocity at intensities of 50% of 1RM to determine the maximum power (w) and the loss of power during the ten repetitions in the leg press exercise.Higher values indicates better functional capacity
Time frame: Changes from baseline to 1st and 3th months of follow up
Geriatric Depression Scale ( GDS) Yesavage abbreviated scale
Depression will be assessed wit the GDS Yesavage abbreviated scale of 15 items. Is is ranged between 0 ( best value) to 15 ( worse value). Scores between 0-5 indicates normality, 5-9 minor depression and scores over 9 indicates mayor depression
Time frame: Changes from baseline to 1st and 3th months of follow up
Categorical pain scale
Pain will be assessed with a subjective categorical pain scale. It is ranged in four categories : 0 ( no pain), 4 ( litle bit), 6 ( quite) , 10 ( a lot)
Time frame: Changes from baseline to and 3th months of follow up
Rate of falls
Rate of new falls during follow up
Time frame: Baseline, 1st and 3th months of follow up
Vivifrail risk of falls scale
Risk of falls will be assessed using Vivifrail methodology. High risk of falls is considered if one of the following questions is positive: 2 o more falls in the last year, a previous fall with medical attention and if the participant scores over 20 seconds in the time up and go test, TUG test ( time of rising from a chair, walking three meters and going back to sitting position) or less than 0.8 m/s in the Gait velocity test
Time frame: Changes from baseline to 1st and 3th months of follow up
Mortality
Mortality will be assessed with a clinical questionnaire during follow up.
Time frame: Changes from baseline to 1st and 3th months of follow up
Admissions to the hospital
New admissions to the hospital will be assessed with a clinical questionnaire during follow up
Time frame: Baseline, 1st and 3th months of follow up
Incidence of institutionalization to nursing homes
New institutionalizations to nursing homes will be assessed with clinical questionary during follow up
Time frame: Baseline, 1st and 3th months of follow up
Visit to emergency room
Visits to emergency room will be assessed with a clinical questionnaire during follow up
Time frame: Baseline, 1st and 3th months of follow up
Number of total Drugs
Number of drugs during follow up will be assessed with a clinical questionnaire
Time frame: Changes from baseline to 3th month´s follow up
Presence of 5 or more drugs ( Polypharmacy ) registration
Registration of the presence of 5 or more drugs( Polypharmacy ) during follow -up will be done with a clinical questionnaire .
Time frame: Changes from baseline to 3th month´s follow up
Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration
Registration of the following physchotropic drugs will be assessed with a clinical questionnaire : neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics
Time frame: Changes from baseline to 3th month´s follow up
Neuropsychiatric Inventory Questionary (NPI)
Assessment of psycho-behavioral symptoms associated to mild cognitive decline or dementia will be assessed with the Neuropsychiatric Inventory Questionary (NPI). NPI is a validated informant-based interview that assesses 12 neuropsychiatric symptoms over the previous month.Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver distress) using a 5-point scale. The NPI provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores.
Time frame: Changes from baseline and 3th month´s follow up
Dual task gait ( arithmetic) 6 m velocity test
The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted (best record will be taking in account) During the arithmetic dual-task condition (arithmetic GVT), we will assess gait velocity while participants are counting backward aloud from 100 by ones
Time frame: Changes from baseline to 1st and 3th months of follow up
Dual task gait (verbal) 6 m velocity test
The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted(best record will be taking in account)During the verbal dual-task condition (verbal GVT), we will assess gait velocity while participants are naming animals by loud
Time frame: Changes from baseline to 1st and 3th months of follow up
EuroQol-5D (EQ-5D) quality of life assessment test
Quality of of life will be assessed with an international validated scale EuroQol-5D (EQ-5D). Its composed by. It asses health status (mobility, personal care, basic and instrumental daily living activities , pain and ansiety/depression) ranged from 0 ( worst health status) to 100 ( best health status )
Time frame: Changes from baseline to 3th month´s follow up
Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )
Presence of other geriatric syndromes ( visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers ) will be assessed with a clinical questionnaire
Time frame: Changes from baseline to 3th month´s follow up
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