<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03831841</url>
  </required_header>
  <id_info>
    <org_study_id>EXERNET Elder 3.0</org_study_id>
    <nct_id>NCT03831841</nct_id>
  </id_info>
  <brief_title>Physical Fitness, Body Composition and Frailty in Elderly People.Exercise Program Effecsts. EXERNET Elder 3.0</brief_title>
  <acronym>EXERNETElder</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the major changes occurring in developed societies is a significant ageing of the&#xD;
      population. Nowadays, because of an enhanced life expectancy, 17% of the Spanish population&#xD;
      is composed of people over 65 and the number is expected to rise to 33% in 2050. Aging is&#xD;
      characterized by a gradual lifelong accumulation of molecular and cellular damage that&#xD;
      results in a progressive and generalized impairment in several bodily functions, an increased&#xD;
      vulnerability to environmental challenges and a growing risk of disease and risk of death.&#xD;
      These facts led to an increase on the prevalence of diseases such as osteoporosis diabetes,&#xD;
      sarcopenia, obesity or frailty. However, lifestyles such as physical activity could&#xD;
      attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated&#xD;
      that even implying guided exercise programs could reverse this condition of frailty and&#xD;
      dependence.&#xD;
&#xD;
      In this way, the main aims of this research project are to analyze the effect of a&#xD;
      multicomponent exercise program in frailty and pre-frailty people above 65 years and without&#xD;
      cognitive impairment. Thus, it is going to be evaluated at the beginning and the end of the&#xD;
      study; body composition, physical fitness, blood parameters including vitamin D and other&#xD;
      health related parameters included in a questionnaire. Secondly, to study the perdurability&#xD;
      of training-related gains over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The training will consist in a multicomponent exercise program, 3 days a week (Monday,&#xD;
      Wednesday and Friday). It will take place during morning in groups of 10-14 and trainers will&#xD;
      be qualified. Alll the exercise will be adapted for different levels of frailty and for their&#xD;
      functional capacity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">December 4, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SPPB</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Senior fitness test physical performance battery</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of 25-OH Vitamin D concentrations</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>25-OH Vitamin D concentration in blood test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on Fried Scale</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Leucocites</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Linfocites</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on hemoglobine</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on platelets</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (10^3/uL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on calcium</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Cholesterol</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on HDL-Cholesterol</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on LDL-Cholesterol</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Trigicerids</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on uric acid</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on urea</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on creatine</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on creatine kinasa</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (U/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on glucose</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on lactate deydrogenase</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (UI/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on potasium</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mEq/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on magnesium</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on transferrine</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on albumin</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (g/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on protein c reative</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Measured by blood test (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Bone mass and structure by perifereal quantitative computed tomography</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on hip perimeter</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Hip perimeter measured following ISAK protocol. Centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on wrist perimeter</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Wrist perimeter following ISAK protocol. Centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on calf perimeter</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Calf perimeter following ISAK protocol. Centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on arm relaxed perimeter</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Calf perimeter following ISAK protocol. Centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on weight</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Change on kilograms by bioimpedance measurement (TANITA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on body fat</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Change on kilograms by bioimpedance measurement (TANITA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on efat percentage</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Change on % by bioimpedance measurement (TANITA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on height</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <description>Change on height (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Unkle-Brachial Index</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on FRAIL Scale</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Clinical frailty scale</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Sociotype Questionnaire for geriatric population</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Physical Activity Questionnnaire for the Elder (PASE)</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Insomnia Severity Index Score</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Incontinence Urinary Questionnaire</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on EUROQOL (EQ-5D)</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Use of hospital Resources</measure>
    <time_frame>Change from Baseline, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Lawton and Brody Index</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Barthel Index</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Risk of falls and Fear to Fall Assesment</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months.</time_frame>
    <description>Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Sun Expousure Questionnaire</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months.</time_frame>
    <description>Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Mediterranean Adherence Questionnaire PREDIMED</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Mini Nutritional Assesment</measure>
    <time_frame>Change from Baseline at 3 months, 6 months and 12 months.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on ExernetElder questionnaire</measure>
    <time_frame>Change from Baseline at 6 months and 12 months.</time_frame>
    <description>Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age.&#xD;
Descriptive registration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Food Frequency Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <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.&#xD;
Each pint is registered but they do not pointed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Sarcopenia</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group with no intervention programe</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multicomponent exercise programe</intervention_name>
    <description>An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 65 years&#xD;
&#xD;
          -  frailty of pre-frailty by SPPB.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>German Vicente-Rodríguez</investigator_full_name>
    <investigator_title>Senior lecturer</investigator_title>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>multicomponent exercise</keyword>
  <keyword>body composition</keyword>
  <keyword>vitamin D</keyword>
  <keyword>fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831841
org study id: EXERNET Elder 3.0
nct id: NCT03831841
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in SPPB
time frame: Change from Baseline at 3 months, 6 months and 12 months
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
measure: Change in Senior fitness test physical performance battery
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Change of 25-OH Vitamin D concentrations
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: 25-OH Vitamin D concentration in blood test
measure: Changes on Fried Scale
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Leucocites
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (%)
measure: Changes on Linfocites
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (%)
measure: Changes on hemoglobine
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (%)
measure: Changes on platelets
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (10^3/uL)
measure: Changes on calcium
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on Cholesterol
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on HDL-Cholesterol
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on LDL-Cholesterol
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on Trigicerids
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on uric acid
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on urea
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on creatine
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on creatine kinasa
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (U/dL)
measure: Changes on glucose
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on lactate deydrogenase
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (UI/dL)
measure: Changes on potasium
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mEq/dL)
measure: Changes on magnesium
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on transferrine
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on albumin
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (g/dL)
measure: Changes on protein c reative
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Measured by blood test (mg/dL)
measure: Changes on Bone mass and structure by perifereal quantitative computed tomography
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Mass and structure of tibia (at 4, 38, 66 % slides) and radius (4, 66 % slides) by pQCT
measure: Changes on hip perimeter
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Hip perimeter measured following ISAK protocol. Centimeters
measure: Change on wrist perimeter
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Wrist perimeter following ISAK protocol. Centimeters
measure: Change on calf perimeter
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Calf perimeter following ISAK protocol. Centimeters
measure: Changes on arm relaxed perimeter
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Calf perimeter following ISAK protocol. Centimeters
measure: Changes on weight
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Change on kilograms by bioimpedance measurement (TANITA)
measure: Changes on body fat
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Change on kilograms by bioimpedance measurement (TANITA)
measure: Changes on efat percentage
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Change on % by bioimpedance measurement (TANITA)
measure: Changes on height
time frame: Change from Baseline at 3 months, 6 months and 12 months
description: Change on height (cm)
measure: Changes on Unkle-Brachial Index
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on FRAIL Scale
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Clinical frailty scale
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Sociotype Questionnaire for geriatric population
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Physical Activity Questionnnaire for the Elder (PASE)
time frame: Change from Baseline at 3 months, 6 months and 12 months
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
measure: Changes on Insomnia Severity Index Score
time frame: Change from Baseline at 3 months, 6 months and 12 months
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)
measure: Changes on Incontinence Urinary Questionnaire
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on EUROQOL (EQ-5D)
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Use of hospital Resources
time frame: Change from Baseline, 6 months and 12 months
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.
measure: Change Lawton and Brody Index
time frame: Change from Baseline at 3 months, 6 months and 12 months
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.
measure: Changes on Barthel Index
time frame: Change from Baseline at 3 months, 6 months and 12 months.
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.
measure: Change on Risk of falls and Fear to Fall Assesment
time frame: Change from Baseline at 3 months, 6 months and 12 months.
description: Questionnaire about, have fear to fall, since when, give up activities because of fear and since when. No puntuation.
measure: Change Sun Expousure Questionnaire
time frame: Change from Baseline at 3 months, 6 months and 12 months.
description: Questionnaire about hours expended outside, sun exposure and skin type. Only registration of data, without puntuations.
measure: Change on Mediterranean Adherence Questionnaire PREDIMED
time frame: Change from Baseline at 3 months, 6 months and 12 months.
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.
measure: Changes on Mini Nutritional Assesment
time frame: Change from Baseline at 3 months, 6 months and 12 months.
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.
measure: Changes on ExernetElder questionnaire
time frame: Change from Baseline at 6 months and 12 months.
description: Questionnaire about sociodemographic aspects such as participation on sports during lifespan, menarchy age and menopause age.
Descriptive registration.
measure: Change on Food Frequency Questionnaire
time frame: Baseline
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.
arm group label: Intervention
arm group type: Experimental
description: Multicomponent exercise programe involving all physical fitness paramenters and consisting on sesions of 1 hour, 3 days a week.
arm group label: Control
arm group type: No Intervention
description: Control group with no intervention programe
intervention type: Behavioral
intervention name: Multicomponent exercise programe
description: An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: German Vicente-Rodríguez
investigator title: Senior lecturer
mesh term: Sarcopenia
mesh term: Frailty
sharing ipd: No