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

Primary Purpose

Frail Elderly Syndrome, Sarcopenia, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent exercise programe
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Elderly Syndrome focused on measuring elderly, multicomponent exercise, body composition, vitamin D, fitness

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Above 65 years
  • frailty of pre-frailty by SPPB.

Exclusion Criteria:

  • Severe cognitive impairment

Sites / Locations

  • Universidad de Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.

Control group with no intervention programe

Outcomes

Primary Outcome Measures

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 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 of 25-OH Vitamin D concentrations
25-OH Vitamin D concentration in blood test

Secondary Outcome Measures

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.
Changes on Leucocites
Measured by blood test (%)
Changes on Linfocites
Measured by blood test (%)
Changes on hemoglobine
Measured by blood test (%)
Changes on platelets
Measured by blood test (10^3/uL)
Changes on calcium
Measured by blood test (mg/dL)
Changes on Cholesterol
Measured by blood test (mg/dL)
Changes on HDL-Cholesterol
Measured by blood test (mg/dL)
Changes on LDL-Cholesterol
Measured by blood test (mg/dL)
Changes on Trigicerids
Measured by blood test (mg/dL)
Changes on uric acid
Measured by blood test (mg/dL)
Changes on urea
Measured by blood test (mg/dL)
Changes on creatine
Measured by blood test (mg/dL)
Changes on creatine kinasa
Measured by blood test (U/dL)
Changes on glucose
Measured by blood test (mg/dL)
Changes on lactate deydrogenase
Measured by blood test (UI/dL)
Changes on potasium
Measured by blood test (mEq/dL)
Changes on magnesium
Measured by blood test (mg/dL)
Changes on transferrine
Measured by blood test (mg/dL)
Changes on albumin
Measured by blood test (g/dL)
Changes on protein c reative
Measured by blood test (mg/dL)
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
Changes on hip perimeter
Hip perimeter measured following ISAK protocol. Centimeters
Change on wrist perimeter
Wrist perimeter following ISAK protocol. Centimeters
Change on calf perimeter
Calf perimeter following ISAK protocol. Centimeters
Changes on arm relaxed perimeter
Calf perimeter following ISAK protocol. Centimeters
Changes on weight
Change on kilograms by bioimpedance measurement (TANITA)
Changes on body fat
Change on kilograms by bioimpedance measurement (TANITA)
Changes on efat percentage
Change on % by bioimpedance measurement (TANITA)
Changes on height
Change on height (cm)
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.
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.
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.
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.
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
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)
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.
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.
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 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.
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 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 Sun Expousure Questionnaire
Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.
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.
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.
Changes on ExernetElder questionnaire
Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age. Descriptive registration.
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.

Full Information

First Posted
December 2, 2018
Last Updated
June 30, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT03831841
Brief Title
Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0
Acronym
EXERNETElder
Official Title
Physical Fitness Body Composition and Frailty in Elderly People Above 65 Years. Mediation of Vitamin D and Exercise Program Effects. EXERNET Elder 3.0
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Sarcopenia, Physical Activity
Keywords
elderly, multicomponent exercise, body composition, vitamin D, fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group with no intervention programe
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent exercise programe
Intervention Description
An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.
Primary Outcome Measure Information:
Title
Change in SPPB
Description
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
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Change in Senior fitness test physical performance battery
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Change of 25-OH Vitamin D concentrations
Description
25-OH Vitamin D concentration in blood test
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Changes on Fried Scale
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Leucocites
Description
Measured by blood test (%)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Linfocites
Description
Measured by blood test (%)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on hemoglobine
Description
Measured by blood test (%)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on platelets
Description
Measured by blood test (10^3/uL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on calcium
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Cholesterol
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on HDL-Cholesterol
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on LDL-Cholesterol
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Trigicerids
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on uric acid
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on urea
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on creatine
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on creatine kinasa
Description
Measured by blood test (U/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on glucose
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on lactate deydrogenase
Description
Measured by blood test (UI/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on potasium
Description
Measured by blood test (mEq/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on magnesium
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on transferrine
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on albumin
Description
Measured by blood test (g/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on protein c reative
Description
Measured by blood test (mg/dL)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Bone mass and structure by perifereal quantitative computed tomography
Description
Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on hip perimeter
Description
Hip perimeter measured following ISAK protocol. Centimeters
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Change on wrist perimeter
Description
Wrist perimeter following ISAK protocol. Centimeters
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Change on calf perimeter
Description
Calf perimeter following ISAK protocol. Centimeters
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on arm relaxed perimeter
Description
Calf perimeter following ISAK protocol. Centimeters
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on weight
Description
Change on kilograms by bioimpedance measurement (TANITA)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on body fat
Description
Change on kilograms by bioimpedance measurement (TANITA)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on efat percentage
Description
Change on % by bioimpedance measurement (TANITA)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on height
Description
Change on height (cm)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Unkle-Brachial Index
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on FRAIL Scale
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Clinical frailty scale
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Sociotype Questionnaire for geriatric population
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Physical Activity Questionnnaire for the Elder (PASE)
Description
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
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Insomnia Severity Index Score
Description
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)
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Incontinence Urinary Questionnaire
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on EUROQOL (EQ-5D)
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Use of hospital Resources
Description
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.
Time Frame
Change from Baseline, 6 months and 12 months
Title
Change Lawton and Brody Index
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months
Title
Changes on Barthel Index
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months.
Title
Change on Risk of falls and Fear to Fall Assesment
Description
Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months.
Title
Change Sun Expousure Questionnaire
Description
Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months.
Title
Change on Mediterranean Adherence Questionnaire PREDIMED
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months.
Title
Changes on Mini Nutritional Assesment
Description
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.
Time Frame
Change from Baseline at 3 months, 6 months and 12 months.
Title
Changes on ExernetElder questionnaire
Description
Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age. Descriptive registration.
Time Frame
Change from Baseline at 6 months and 12 months.
Title
Change on Food Frequency Questionnaire
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Above 65 years frailty of pre-frailty by SPPB. Exclusion Criteria: Severe cognitive impairment
Facility Information:
Facility Name
Universidad de Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35876120
Citation
Fernandez-Garcia AI, Gomez-Cabello A, Gomez-Bruton A, Moradell A, Navarrete-Villanueva D, Perez-Gomez J, Gonzalez-Gross M, Ara I, Casajus JA, Vicente-Rodriguez G. Effects of multicomponent training and detraining on the fitness of older adults with or at risk of frailty: results of a 10-month quasi-experimental study. Eur J Sport Sci. 2023 Aug;23(8):1696-1709. doi: 10.1080/17461391.2022.2104657. Epub 2022 Aug 11.
Results Reference
derived
PubMed Identifier
35816744
Citation
Moradell A, Fernandez-Garcia AI, Navarrete-Villanueva D, Perez-Gomez J, Gesteiro E, Ara Royo I, Casajus JA, Gomez-Cabello A, Vicente-Rodriguez G. Does nutritional status influence the effects of a multicomponent exercise programme on body composition and physical fitness in older adults with limited physical function? Eur J Sport Sci. 2023 Jul;23(7):1375-1384. doi: 10.1080/17461391.2022.2092426. Epub 2022 Jul 11.
Results Reference
derived

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

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