<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/NCT03831373</url>
  </required_header>
  <id_info>
    <org_study_id>16-1009-17</org_study_id>
    <nct_id>NCT03831373</nct_id>
  </id_info>
  <brief_title>Upper Versus Lower Body Resistance Exercise in Older Adults</brief_title>
  <official_title>Effects of Resistance Exercise Focused on the Upper Body Versus the Lower Body on Global Physical Fitness and Cognitive Status of Older Adults Living in Geriatric Centers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vigo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vigo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      TITLE: Relation between focused resistance training and its effect on cognitive performance&#xD;
      and functional Independence of institutionalized elderly.&#xD;
&#xD;
      HIPOTHESIS: The performance of a physical exercise program based on resistance training in&#xD;
      older adults stabilizes or improves some parameters of the functional independence as well as&#xD;
      the cognitive function, finding effects overall organism by the focused training of some&#xD;
      muscular groups.&#xD;
&#xD;
      GENERAL OBJECTIVES: 1) to analyze the differential effects of an exercise program based on&#xD;
      the training of the muscular strength of the upper body versus a lower body one, at short and&#xD;
      long term in institutionalized elderly people; 2) to identify if there is any relations&#xD;
      between the variables that induce frailness or functional dependence and the physical&#xD;
      exercise program.&#xD;
&#xD;
      SPECIFIC OBJECTIVES: To determine the differential effects of a physical exercise program&#xD;
      based on the development of the muscular strength of the upper body versus the lower body, in&#xD;
      sessions of 40 minutes a day, 2 days per week during 7 months on: a) The improvement of&#xD;
      functional independence by the amelioration of balance, decrease of fall risk and an adequate&#xD;
      development in the activities of daily living; b) The improvement of the global cognitive&#xD;
      function; c) The improvement of the quality of life.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
        -  Design: Controlled trial. The institutionalized elderly from the geriatric centers will&#xD;
           be invited to take part in the study. After they meet the selection criteria, they will&#xD;
           be assigned to two experimental groups and one control group in each center. Information&#xD;
           regarding sociodemographic characteristics and a clinical anamnesis of the participants&#xD;
           will be collected.&#xD;
&#xD;
        -  Intervention: Three groups, one from each centre. Two centers, experimental groups, will&#xD;
           perform two physical exercises programs of resistance training with elastic bands, one&#xD;
           focused on the upper and one on the lower body. They will be carried 2 days per week,&#xD;
           during 3 months in 45-minute sessions. The program will consist of 5 exercises, with a&#xD;
           volume of 4 sets of 12 repetitions, with 2-minute breaks between sets and 3 between&#xD;
           exercises. Control group will participate in 40 minutes stretching sessions, 3 times per&#xD;
           week. After 3 months of exercise and after three months of transition, they experimental&#xD;
           groups will perform the other program for another 3 months, crossing the interventions.&#xD;
&#xD;
        -  Assessments: Six will be carried: At the beginning, at the end of the first&#xD;
           intervention, at the beginning of the second one, at the end and a follow up 3 months&#xD;
           later. In each, it will be assessed the potential cognitive impairment and cognitive&#xD;
           status (Spanish version of the MMSE, Fototest and Trail Making Test part A), functional&#xD;
           independence (Timed Up and Go Test), grip strength (hand dynamometer), lower body&#xD;
           strength (30 Seconds Chair Stands) and flexibility/mobility (Chair Sit-and-Reach and&#xD;
           Back Scratch Test.)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2018</start_date>
  <completion_date type="Actual">March 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spanish version of the Mini-Mental State Examination.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The Mini-Mental State Examination is a 30-point questionnaire comprised by eight different categories and score range. Orientation to time (0-5 points) Orientation to place (0-5 points) Registration (0-3 points) Attention and calculation (0-5 points) Recall (0-3 points) Language (0-2 points) Repetition (0-1 points) Complex commands (0-6 points). Interpretation: Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. ≤9 points: severe cognitive impairment 10-18 points: moderate cognitive impairment and 19-23 points: mild cognitive impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test of the pictures</measure>
    <time_frame>24 weeks</time_frame>
    <description>The test of the pictures (Fototest in the Spanish version) is used to assess the short and long-term memory, the verbal fluency and denomination capacities. The test is well correlated with the Mini-mental State Examination and it's reference values are situated in 34.4±4.4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test part A.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The Trail Making Test part A. The time required by an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper is measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>24 weeks</time_frame>
    <description>Standardized test to assess the basic functional mobility of elderly persons. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grip Strength</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by means of a hand-held dynamometer, Grip Strength: By means of a hand-held dynamometer, this assessment has been stated as a predictor of frailty and mortality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chair Sit and Reach</measure>
    <time_frame>24 weeks</time_frame>
    <description>Present in the Senior Fitness Test, to assess the mobility/flexibility of the lower back and limbs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Back Scratch Test</measure>
    <time_frame>24 weeks</time_frame>
    <description>Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Quality of Life</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Upper-limb-focused resistance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower-limb-focused resistance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lower-limb-focused resistance training with elastic bands.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stretching exercise program in a sitting position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.</description>
    <arm_group_label>Lower-limb-focused resistance training</arm_group_label>
    <arm_group_label>Stretching exercise</arm_group_label>
    <arm_group_label>Upper-limb-focused resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No medical contraindications to be involved in the exercise programs.&#xD;
&#xD;
          -  To be able to follow the exercise classes&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DomusVi Barreiro</name>
      <address>
        <city>Vigo</city>
        <state>Galicia</state>
        <zip>362014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 9, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vigo</investigator_affiliation>
    <investigator_full_name>Miguel A. Sánchez-Lastra</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <!-- 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/NCT03831373
org study id: 16-1009-17
nct id: NCT03831373
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
TITLE: Relation between focused resistance training and its effect on cognitive performance
      and functional Independence of institutionalized elderly.

      HIPOTHESIS: The performance of a physical exercise program based on resistance training in
      older adults stabilizes or improves some parameters of the functional independence as well as
      the cognitive function, finding effects overall organism by the focused training of some
      muscular groups.

      GENERAL OBJECTIVES: 1) to analyze the differential effects of an exercise program based on
      the training of the muscular strength of the upper body versus a lower body one, at short and
      long term in institutionalized elderly people; 2) to identify if there is any relations
      between the variables that induce frailness or functional dependence and the physical
      exercise program.

      SPECIFIC OBJECTIVES: To determine the differential effects of a physical exercise program
      based on the development of the muscular strength of the upper body versus the lower body, in
      sessions of 40 minutes a day, 2 days per week during 7 months on: a) The improvement of
      functional independence by the amelioration of balance, decrease of fall risk and an adequate
      development in the activities of daily living; b) The improvement of the global cognitive
      function; c) The improvement of the quality of life.

      METHODS

        -  Design: Controlled trial. The institutionalized elderly from the geriatric centers will
           be invited to take part in the study. After they meet the selection criteria, they will
           be assigned to two experimental groups and one control group in each center. Information
           regarding sociodemographic characteristics and a clinical anamnesis of the participants
           will be collected.

        -  Intervention: Three groups, one from each centre. Two centers, experimental groups, will
           perform two physical exercises programs of resistance training with elastic bands, one
           focused on the upper and one on the lower body. They will be carried 2 days per week,
           during 3 months in 45-minute sessions. The program will consist of 5 exercises, with a
           volume of 4 sets of 12 repetitions, with 2-minute breaks between sets and 3 between
           exercises. Control group will participate in 40 minutes stretching sessions, 3 times per
           week. After 3 months of exercise and after three months of transition, they experimental
           groups will perform the other program for another 3 months, crossing the interventions.

        -  Assessments: Six will be carried: At the beginning, at the end of the first
           intervention, at the beginning of the second one, at the end and a follow up 3 months
           later. In each, it will be assessed the potential cognitive impairment and cognitive
           status (Spanish version of the MMSE, Fototest and Trail Making Test part A), functional
           independence (Timed Up and Go Test), grip strength (hand dynamometer), lower body
           strength (30 Seconds Chair Stands) and flexibility/mobility (Chair Sit-and-Reach and
           Back Scratch Test.)
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Spanish version of the Mini-Mental State Examination.
time frame: 24 weeks
description: The Mini-Mental State Examination is a 30-point questionnaire comprised by eight different categories and score range. Orientation to time (0-5 points) Orientation to place (0-5 points) Registration (0-3 points) Attention and calculation (0-5 points) Recall (0-3 points) Language (0-2 points) Repetition (0-1 points) Complex commands (0-6 points). Interpretation: Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. ≤9 points: severe cognitive impairment 10-18 points: moderate cognitive impairment and 19-23 points: mild cognitive impairment.
measure: Test of the pictures
time frame: 24 weeks
description: The test of the pictures (Fototest in the Spanish version) is used to assess the short and long-term memory, the verbal fluency and denomination capacities. The test is well correlated with the Mini-mental State Examination and it's reference values are situated in 34.4±4.4.
measure: Trail Making Test part A.
time frame: 24 weeks
description: The Trail Making Test part A. The time required by an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper is measured.
measure: Timed Up and Go Test
time frame: 24 weeks
description: Standardized test to assess the basic functional mobility of elderly persons. The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
measure: Grip Strength
time frame: 24 weeks
description: Assessed by means of a hand-held dynamometer, Grip Strength: By means of a hand-held dynamometer, this assessment has been stated as a predictor of frailty and mortality.
measure: Chair Sit and Reach
time frame: 24 weeks
description: Present in the Senior Fitness Test, to assess the mobility/flexibility of the lower back and limbs.
measure: Back Scratch Test
time frame: 24 weeks
description: Present in the Senior Fitness Test, this evaluates the joint mobility of the shoulders.
arm group label: Upper-limb-focused resistance training
arm group type: Experimental
arm group label: Lower-limb-focused resistance training
arm group type: Experimental
description: Lower-limb-focused resistance training with elastic bands.
arm group label: Stretching exercise
arm group type: Active Comparator
description: Stretching exercise program in a sitting position.
intervention type: Other
intervention name: Physical exercise
description: Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.
arm group label: Lower-limb-focused resistance training
arm group label: Stretching exercise
arm group label: Upper-limb-focused resistance training
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Vigo
investigator full name: Miguel A. Sánchez-Lastra
investigator title: Principal Investigator