Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0

Study Overview
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Brief Summary
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One of the major changes occurring in developed societies is a significant ageing of the population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. Aging is characterized by a gradual lifelong accumulation of molecular and cellular damage that results in a progressive and generalized impairment in several bodily functions, an increased vulnerability to environmental challenges and a growing risk of disease and risk of death. These facts led to an increase on the prevalence of diseases such as osteoporosis diabetes, sarcopenia, obesity or frailty. However, lifestyles such as physical activity could attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated that even implying guided exercise programs could reverse this condition of frailty and dependence. In this way, the main aims of this research project are to analyze the effect of a multicomponent exercise program in frailty and pre-frailty people above 65 years and without cognitive impairment. Thus, it is going to be evaluated at the beginning and the end of the study; body composition, physical fitness, blood parameters including vitamin D and other health related parameters included in a questionnaire. Secondly, to study the perdurability of training-related gains over time.

Detailed Description
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The training will consist in a multicomponent exercise program, 3 days a week (Monday, Wednesday and Friday). It will take place during morning in groups of 10-14 and trainers will be qualified. Alll the exercise will be adapted for different levels of frailty and for their functional capacity.

Official Title
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Physical Fitness Body Composition and Frailty in Elderly People Above 65 Years. Mediation of Vitamin D and Exercise Program Effects. EXERNET Elder 3.0

Conditions
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Frail Elderly Syndrome, Sarcopenia, Physical Activity

Intervention / Treatment
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* Behavioral: Multicomponent exercise programe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 65 years frailty of pre-frailty by SPPB. Exclusion Criteria: Severe cognitive impairment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week. | Behavioral: Multicomponent exercise programe<br>* An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.<br>|
| No Intervention: Control<br>Control group with no intervention programe | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SPPB | Short Physical Performance Battery by Romberg (SPPB): consist of walking 4m, a balance test with three levels (tandem, semi-tandem and stand up on one foot) and sit up and reach 5 times as fast as possible. Each test could point from 0 to 4, reaching a maximum of 12 months in the battery. Puntuation correspond to; 0-4 points the person is not valid, from 4 to 6 frails and form 7-9 pre-frailt | Change from Baseline at 3 months, 6 months and 12 months | 
| Change in Senior fitness test physical performance battery | A fitness test battery in order to measured physical performance of elderly, it includes: flamingos test (for balance), 30m of walking speed, 30 seconds of sit and reach (strength of lower extremities), 30sconds of arm curl, 6 minutes test (aerobic capacity), sit-up and go test (agility), flexibility of upper and lower extremities. Results are registered without puntuation. | Change from Baseline at 3 months, 6 months and 12 months | 
| Change of 25-OH Vitamin D concentrations | 25-OH Vitamin D concentration in blood test | Change from Baseline at 3 months, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on Fried Scale | Fried frailty phenotype criteria; measured by 3 questiones (exhaustion, walking more than 2 or 2,5 jours a week (for men or women)a and to have lose weigth (4,5kg) in the last year), Handgrip and 4,5 meters walking. Those who point 2 or 3 are prefrail and 3 or more frail. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Leucocites | Measured by blood test (%) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Linfocites | Measured by blood test (%) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on hemoglobine | Measured by blood test (%) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on platelets | Measured by blood test (10^3/uL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on calcium | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Cholesterol | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on HDL-Cholesterol | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on LDL-Cholesterol | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Trigicerids | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on uric acid | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on urea | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on creatine | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on creatine kinasa | Measured by blood test (U/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on glucose | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on lactate deydrogenase | Measured by blood test (UI/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on potasium | Measured by blood test (mEq/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on magnesium | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on transferrine | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on albumin | Measured by blood test (g/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on protein c reative | Measured by blood test (mg/dL) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Bone mass and structure by perifereal quantitative computed tomography | Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on hip perimeter | Hip perimeter measured following ISAK protocol. Centimeters | Change from Baseline at 3 months, 6 months and 12 months | 
| Change on wrist perimeter | Wrist perimeter following ISAK protocol. Centimeters | Change from Baseline at 3 months, 6 months and 12 months | 
| Change on calf perimeter | Calf perimeter following ISAK protocol. Centimeters | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on arm relaxed perimeter | Calf perimeter following ISAK protocol. Centimeters | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on weight | Change on kilograms by bioimpedance measurement (TANITA) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on body fat | Change on kilograms by bioimpedance measurement (TANITA) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on efat percentage | Change on % by bioimpedance measurement (TANITA) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on height | Change on height (cm) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Unkle-Brachial Index | Vascular measure to observed blood circultaion. With a Doppler, sistolic blood pressure measured in brachial arteries (humerus) and unkle arteries are measured. Then, ratio is calculated dividing both results. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on FRAIL Scale | 5 questions scale asking about; lose a 5% of own weigth in the last year, to have more than 5 diseases between cancer, diabetes, chloresterol, asthma, EPOC, IAM, cardiac insuficiency, arthritis, ACVA, ERC, angina, hipertension), exhaustion in the last 4 weeks ,ability to walk 10 steps without help, ability to walk more than 100 meters without help. Confirm 3 or more items means to be frail. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Clinical frailty scale | A descriptive scale about disability and funcional assessments. Is a practical and efficient tool for assessing frailty. It is compound of 9 options describing stages functionality depending on how much help they need for daily activities (1- very fit, 2- well, 3- managing well, 4- vulnerable, 5- mildly frail, 6- moderately frail, 7- severely frail, 8-very severely frail, 9- terminally ill). One option have to be selected. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Sociotype Questionnaire for geriatric population | Questionnaire about how people stablish their relationships between three social dimensions (family, friendship, and acquaintance). The questionnaire consisted of 12 questions which point from 0 to 5, having the high punctuation a positive meaning. Final mark is obtained from de sum up pf every point of each question. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Physical Activity Questionnnaire for the Elder (PASE) | Physical activity questionnaire to assesed daily light, moderate and vigorous physical activities. Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in persons age 65 years and older. The PASE score combines information on leisure, household and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. A total of 10 questions using frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. Contribution of each questionnaire item to the overall PASE score is determined by the product of the sample mean and activity weight | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Insomnia Severity Index Score | The Insomnia Severity Index (ISI) is a short instrument developed to assess insomnia severity Seven questions asking severity of difficulties to falling asleep, staying asleep, waking up too much early, how unsatisfied the person is with his sleep, how affect daily if there is a problem of sleep life. Severity must be pointed from 0 to 4 and the sum up of all question is calculated for the final mark. 0-7 lack of insomnia, 8-14 subclinical insomnia, 15-21 clinical insomnia (mild), 22-28 clinical insomnia (grave) | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Incontinence Urinary Questionnaire | Questionnaire about urinary incontinence, how it affects they daily life pointing from 1 to 10 (being 10 too much worry) and when it happens. This question does not point, they are only registered. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on EUROQOL (EQ-5D) | EQ-5D is a standardised measure of health status developed in order to provide a simple, generic measure of health for clinical and economic appraisal. It descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The second part of the questionnire records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. It should be noted that the numerals 1-3 have no arithmetic properties and should not be used as a cardinal score. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Use of hospital Resources | Descriptive measure. Registration through the hospital internet private platform of; medication of the patient, number of medical appointments, number of specialised complementary tests, and other medical resourse that could be used by the patient related to healthcare system. | Change from Baseline, 6 months and 12 months | 
| Change Lawton and Brody Index | Questionnaire about instrumental activities of daily life; Ability to Use Telephone Shopping, Laundry, Mode of Transportation, Food Preparation, Responsibility for Own Medications, Housekeeping and Ability to Handle Finances. Each part has 4 options to tick in order of independent to more dependent. Highest mark is 8 and correspond to a summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias. | Change from Baseline at 3 months, 6 months and 12 months | 
| Changes on Barthel Index | Questionnaire about authonomy and dependence in; Feeding, Bathing , Grooming , Dressing , Bowel control , Bladder control , Toilet use , Transfers (bed to chair and back) (, Mobility on level surfaces , Stairs. Puntuation correspond to Independent +10points, Needs help+5points, Unable 0 points). Maximal puntuation is 100.which means independence. | Change from Baseline at 3 months, 6 months and 12 months. | 
| Change on Risk of falls and Fear to Fall Assesment | Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation. | Change from Baseline at 3 months, 6 months and 12 months. | 
| Change Sun Expousure Questionnaire | Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations. | Change from Baseline at 3 months, 6 months and 12 months. | 
| Change on Mediterranean Adherence Questionnaire PREDIMED | 14 items questionnaire about adherence to Mediterranean diet patron each question is puntuated with 1 (positive to mediterrranean diet) or 0. The total puntuation is a sum up from the 14 questions. Questions are about olive oil , vegetable and fruit , meat, desserts, wine, fish, and legumes consumption. | Change from Baseline at 3 months, 6 months and 12 months. | 
| Changes on Mini Nutritional Assesment | The MNA is a screening tool composed of two parts, 6 and 12 questions.First part permits detection of a decline in ingestion over the past three months (loss of appetite, decline of food intake, digestive problems, chewing or swallowing difficulties), weight loss in the past three months, current mobility impairment, an acute illness or major stress in the past three months, a neuropsychological problem (dementia or depression) and a decrease in body mass index (BMI). Second part of MNA evaluates living arrangements, the presence of polypharmacy or pressure ulcers, the number of full meals eaten daily, the amount and frequency of specific foods and fluids, and the mode of feeding. The patient reports nutritional and health status, and the practitioner determines weight and height (to calculate BMI), and mid-arm and mid-calf circumferences. The maximum score for first part is 14; a score of 12 points or greater means disorders. | Change from Baseline at 3 months, 6 months and 12 months. | 
| Changes on ExernetElder questionnaire | Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age. Descriptive registration. | Change from Baseline at 6 months and 12 months. | 
| Change on Food Frequency Questionnaire | Food intake questionnaire (PREDIMED) asking about frequence of eating each food in last month. 139 different food from groups as daily products, eggs, meats and fishes, vegetables, fruits, legumes, fats and oils, desserts, miscalaneas and drinks. Each food could be answer with never, 1-3 a month, 1 a week, 2-4 a week, 5-6 a week, 1 a day, 2-3 a day, 4-6 a day, +6 a day. Each pint is registered but they do not pointed. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, multicomponent exercise, body composition, vitamin D, fitness