<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/NCT03823183</url>
  </required_header>
  <id_info>
    <org_study_id>PSI2016-80377-R</org_study_id>
    <nct_id>NCT03823183</nct_id>
  </id_info>
  <brief_title>Multi-domain Versus Uni-Domain Training on Executive Control and Memory Functions of Older Adults</brief_title>
  <acronym>VIBAL</acronym>
  <official_title>Protocol for a Randomized Controlled Trial With Active Control on the Effects of Combined Physical and Cognitive Training Versus Cognitive and Physical Training Separately on Executive Control and Memory Functions of Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Educación a Distancia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Economy and Competitiveness (MINECO) - Government of Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Nacional de Educación a Distancia</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>
      Age-related cognitive decline affects negatively daily living and quality of life of older&#xD;
      adults. Previous research has shown a moderate impact of cognitive and physical training on&#xD;
      the cognitive functioning of elders. This randomized controlled trial (RCT) examines the&#xD;
      differential impact of multi-domain cognitive (video game training) and physical training&#xD;
      (the physical exercise was Body-attack, a mixed of dance, aerobic, strength, and muscular&#xD;
      resistance versus cognitive training and physical training separately, on executive control&#xD;
      and memory functions of healthy older adults (N=120), in comparison with an active control&#xD;
      group. Participants (between 60 and 80 years old) will be allocated randomly to one of the&#xD;
      four experimental groups: 1) physical training-single domain: physical training and cognitive&#xD;
      control activity; 2) cognitive training-single domain: cognitive training and physical&#xD;
      control activity; 3) cognitive-physical multi-domain: physical training and cognitive&#xD;
      training; 4) active control: physical control activity and cognitive control activity.&#xD;
      Physical training will be group-based and include coordination, aerobic exercise and strength&#xD;
      exercise. The physical control activity will include stretching and relaxation exercises. The&#xD;
      cognitive training will consist of commercial brain training video games. Difficulty will be&#xD;
      automatically adjusted to the performance level of the participant. The cognitive control&#xD;
      activity will be cognitively non-demanding video games. Physical activities (experimental and&#xD;
      control) will be trained for 40 min and cognitive activities (experimental and control) for&#xD;
      40 min consecutively during the same session. There will be 2 session/wk over 3 months.&#xD;
      Executive functioning, memory functions and psychological wellbeing will be assessed using&#xD;
      behavioral and electrophysiological measures at baseline, after study completion and at&#xD;
      3-month follow-up. The main goal was to investigate possible intervention-related transfer&#xD;
      effects to untrained executive and memory functions. The goal is to find out whether&#xD;
      multi-domain training improves more executive and memory functions that are often compromised&#xD;
      in later years, but essential for everyday activities. We expect to find larger transfer&#xD;
      effects in the multi-domain condition than in the uni-domain conditions, shorter ERP&#xD;
      latencies of the P2 component, and enhanced N2 and P3b components after training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants complete one of the four combinations of cognitive training with video games&#xD;
      and physical exercise. The cognitive component will be either a brain training video game&#xD;
      program selected from Lumosity (cognitive intervention, CI) or video games not specifically&#xD;
      designed to train attention and executive control (cognitive control, CC). The physical&#xD;
      exercise component will be either Body-attack, a combination of dance, aerobic, strength, and&#xD;
      muscular resistance (exercise intervention, EI) or its control condition composed of&#xD;
      stretching, toning and relaxation (exercise control, EC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>This study includes 4 intervention conditions: (1) Multi-modal Cognitive intervention + Physical intervention, (2) Cognitive intervention + Physical control, (3) Physical intervention + Cognitive control, and (4) Active Control group, Cognitive control + Physical control) x 3 (Time: Pretest, Post-test, 3-month follow-up) mixed factorial design, with &quot;Type of training&quot; as between-subject factors and &quot;Time&quot; as within-subject factor. The dependent variables will be behavioral and/or electrophysiological measures of executive functions (inhibition, shifting, working memory), memory functions (short term, episodic memory), and emotional well-being, quality of live and motivation.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Executive functions assessed with Memory-based Task Switching</measure>
    <time_frame>Change from Baseline in Memory-based Task Switching to 3 and 6 months</time_frame>
    <description>Reaction time (RT) of correct responses in Memory-based Task Switching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive functions assessed with Memory-based Task Switching</measure>
    <time_frame>Change from Baseline in Memory-based Task Switching to 3 and 6 months</time_frame>
    <description>Performance in the Memory-base Task Switching: Neurophysiological parameter-Event-related potentials (ERPs) in the Memory-Based Task Switching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attention assessed with Trail Making Test A+B</measure>
    <time_frame>Change from Baseline in Trail Making Test to 3 and 6 months</time_frame>
    <description>Performance in Trail Making Test A+B score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inhibition assessed with Stroop Task</measure>
    <time_frame>Change from Baseline in Stroop Task to 3 and 6 months</time_frame>
    <description>Reaction time (RT) of correct responses in the Stroop Task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working memory assessed with the N-back Task</measure>
    <time_frame>Change from Baseline in the N-Back Task to 3 and 6 months</time_frame>
    <description>Hits-False Alarms in the N-back Task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)</measure>
    <time_frame>Change from Baseline in Face I to 3 and 6 months</time_frame>
    <description>Units on the Scale: scale range (minimum score = 0 and maximum score = 48).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)</measure>
    <time_frame>Change from Baseline in Face II to 3 and 6 months</time_frame>
    <description>Units on the Scale: scale range (minimum score = 0 and maximum score = 48).&#xD;
With data from Visual Memory Face I (inmediate recognition) and Visual Memory Face II (differed recognition) we compute the percentage of memory retention = Visual Memory Face II / Visual Memory Face I X 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)</measure>
    <time_frame>Change from Baseline in Pair-Words I to 3 and 6 months</time_frame>
    <description>Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 32).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)</measure>
    <time_frame>Change from Baseline in Pair-Words II to 3 and 6 months</time_frame>
    <description>Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 8).&#xD;
scale range for Recognition (minimum score =0 and maximum score = 24)&#xD;
Recall. With data from Pair-Words I (inmediate recognition) and Pair-Words II (differed recognition) we compute the percentage of memory retention = Pair-Words II / Pair-Word I X 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Change from Baseline in PANAS to 3 and 6 months</time_frame>
    <description>Units on the Scale: 20 items Each item is evaluated between 0 (nothing) and 5 (many). Positive emotions are assessed with items: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19. Negative emotions are assessed with items: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional and affective wellbeing assessed with The Life Satisfaction Index (LSI): 20 items Each item is assessed using two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.</measure>
    <time_frame>Change from Baseline in LSI to 3 and 6 months</time_frame>
    <description>Units on the Scale: 20 items A two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardio-respiratory capacity assessed with the 6 Minutes Walk Test</measure>
    <time_frame>Change from Baseline in 6 Minutes Walk Test to 3 and 6 months</time_frame>
    <description>Physiological parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical dimension assessed with The Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Change from Baseline in SPPB to 3 and 6 months</time_frame>
    <description>Units on the Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic interview and medical history</measure>
    <time_frame>Baseline</time_frame>
    <description>Respond to questions related to demographics and medical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General cognitive state assessed with Mini Mental State Examination (MMSE)</measure>
    <time_frame>Baseline</time_frame>
    <description>Units on the test: scale range (minimum score = 0 and maximum score = 30). Values between 27 and 30 points are considered as &quot;appropriate cognitive state&quot;.&#xD;
Values between 24 and 26 points are considered as &quot;possible mild cognitive impairment&quot; Values between 0 and 23 points are considered as &quot;possible dementia&quot;. This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores under 27 will be excluded from the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Units on the test: scale range (minimum score = 0 and maximum score = 15). Values between 0 and 5 points are considered as &quot;no depression&quot;. Values between 5 and 10 points are considered as &quot;mild depression&quot; Values between 10 and 15 points are considered as &quot;severe depression&quot;. This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores greater than 5 will be excluded from the study.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Executive Functions</condition>
  <condition>Memory Functions</condition>
  <arm_group>
    <arm_group_label>Multi-domain training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that receives cognitive training and physical training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that receives cognitive training and physical control activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that receives control cognitive activity and physical training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group that receives cognitive control activity and physical control activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive training</intervention_name>
    <description>Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.</description>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_label>Multi-domain training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical training</intervention_name>
    <description>Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.</description>
    <arm_group_label>Multi-domain training</arm_group_label>
    <arm_group_label>Physical activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive control</intervention_name>
    <description>Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.</description>
    <arm_group_label>Active control</arm_group_label>
    <arm_group_label>Physical activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical control</intervention_name>
    <description>Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.</description>
    <arm_group_label>Active control</arm_group_label>
    <arm_group_label>Cognitive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        No current intensive sports or physical activity practice. No current use of brain-training&#xD;
        video games&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Dementia. Mild Cognitive Impairment. A neurological or major psychiatric disorder.&#xD;
        Significant heart illness. Lung disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soledad Ballesteros, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNED</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Basic Psychology II (UNED)</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional de Educación a Distancia</investigator_affiliation>
    <investigator_full_name>Soledad Ballesteros</investigator_full_name>
    <investigator_title>Investigator Official Title Ph.D. Emeritus Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Aging, geriatrics &amp; gerontology</keyword>
  <keyword>Video-game cognitive training</keyword>
  <keyword>Dance</keyword>
  <keyword>Physical exercise</keyword>
  <keyword>Multi-domain training</keyword>
  <keyword>Executive functions</keyword>
  <keyword>Memory functions</keyword>
  <keyword>Plasticity</keyword>
  <keyword>Transfer</keyword>
  <keyword>Follow-up intervention</keyword>
  <keyword>Randomized controlled trial</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03823183
org study id: PSI2016-80377-R
nct id: NCT03823183
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Age-related cognitive decline affects negatively daily living and quality of life of older
      adults. Previous research has shown a moderate impact of cognitive and physical training on
      the cognitive functioning of elders. This randomized controlled trial (RCT) examines the
      differential impact of multi-domain cognitive (video game training) and physical training
      (the physical exercise was Body-attack, a mixed of dance, aerobic, strength, and muscular
      resistance versus cognitive training and physical training separately, on executive control
      and memory functions of healthy older adults (N=120), in comparison with an active control
      group. Participants (between 60 and 80 years old) will be allocated randomly to one of the
      four experimental groups: 1) physical training-single domain: physical training and cognitive
      control activity; 2) cognitive training-single domain: cognitive training and physical
      control activity; 3) cognitive-physical multi-domain: physical training and cognitive
      training; 4) active control: physical control activity and cognitive control activity.
      Physical training will be group-based and include coordination, aerobic exercise and strength
      exercise. The physical control activity will include stretching and relaxation exercises. The
      cognitive training will consist of commercial brain training video games. Difficulty will be
      automatically adjusted to the performance level of the participant. The cognitive control
      activity will be cognitively non-demanding video games. Physical activities (experimental and
      control) will be trained for 40 min and cognitive activities (experimental and control) for
      40 min consecutively during the same session. There will be 2 session/wk over 3 months.
      Executive functioning, memory functions and psychological wellbeing will be assessed using
      behavioral and electrophysiological measures at baseline, after study completion and at
      3-month follow-up. The main goal was to investigate possible intervention-related transfer
      effects to untrained executive and memory functions. The goal is to find out whether
      multi-domain training improves more executive and memory functions that are often compromised
      in later years, but essential for everyday activities. We expect to find larger transfer
      effects in the multi-domain condition than in the uni-domain conditions, shorter ERP
      latencies of the P2 component, and enhanced N2 and P3b components after training.
All participants complete one of the four combinations of cognitive training with video games
      and physical exercise. The cognitive component will be either a brain training video game
      program selected from Lumosity (cognitive intervention, CI) or video games not specifically
      designed to train attention and executive control (cognitive control, CC). The physical
      exercise component will be either Body-attack, a combination of dance, aerobic, strength, and
      muscular resistance (exercise intervention, EI) or its control condition composed of
      stretching, toning and relaxation (exercise control, EC).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This study includes 4 intervention conditions: (1) Multi-modal Cognitive intervention + Physical intervention, (2) Cognitive intervention + Physical control, (3) Physical intervention + Cognitive control, and (4) Active Control group, Cognitive control + Physical control) x 3 (Time: Pretest, Post-test, 3-month follow-up) mixed factorial design, with "Type of training" as between-subject factors and "Time" as within-subject factor. The dependent variables will be behavioral and/or electrophysiological measures of executive functions (inhibition, shifting, working memory), memory functions (short term, episodic memory), and emotional well-being, quality of live and motivation.
primary purpose: Basic Science
masking: Single (Participant)
measure: Executive functions assessed with Memory-based Task Switching
time frame: Change from Baseline in Memory-based Task Switching to 3 and 6 months
description: Reaction time (RT) of correct responses in Memory-based Task Switching
measure: Executive functions assessed with Memory-based Task Switching
time frame: Change from Baseline in Memory-based Task Switching to 3 and 6 months
description: Performance in the Memory-base Task Switching: Neurophysiological parameter-Event-related potentials (ERPs) in the Memory-Based Task Switching
measure: Attention assessed with Trail Making Test A+B
time frame: Change from Baseline in Trail Making Test to 3 and 6 months
description: Performance in Trail Making Test A+B score
measure: Inhibition assessed with Stroop Task
time frame: Change from Baseline in Stroop Task to 3 and 6 months
description: Reaction time (RT) of correct responses in the Stroop Task
measure: Working memory assessed with the N-back Task
time frame: Change from Baseline in the N-Back Task to 3 and 6 months
description: Hits-False Alarms in the N-back Task
measure: Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)
time frame: Change from Baseline in Face I to 3 and 6 months
description: Units on the Scale: scale range (minimum score = 0 and maximum score = 48).
measure: Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)
time frame: Change from Baseline in Face II to 3 and 6 months
description: Units on the Scale: scale range (minimum score = 0 and maximum score = 48).
With data from Visual Memory Face I (inmediate recognition) and Visual Memory Face II (differed recognition) we compute the percentage of memory retention = Visual Memory Face II / Visual Memory Face I X 100
measure: Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)
time frame: Change from Baseline in Pair-Words I to 3 and 6 months
description: Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 32).
measure: Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)
time frame: Change from Baseline in Pair-Words II to 3 and 6 months
description: Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 8).
scale range for Recognition (minimum score =0 and maximum score = 24)
Recall. With data from Pair-Words I (inmediate recognition) and Pair-Words II (differed recognition) we compute the percentage of memory retention = Pair-Words II / Pair-Word I X 100
measure: Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)
time frame: Change from Baseline in PANAS to 3 and 6 months
description: Units on the Scale: 20 items Each item is evaluated between 0 (nothing) and 5 (many). Positive emotions are assessed with items: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19. Negative emotions are assessed with items: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20.
measure: Emotional and affective wellbeing assessed with The Life Satisfaction Index (LSI): 20 items Each item is assessed using two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.
time frame: Change from Baseline in LSI to 3 and 6 months
description: Units on the Scale: 20 items A two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.
measure: Cardio-respiratory capacity assessed with the 6 Minutes Walk Test
time frame: Change from Baseline in 6 Minutes Walk Test to 3 and 6 months
description: Physiological parameter
measure: Physical dimension assessed with The Short Physical Performance Battery (SPPB)
time frame: Change from Baseline in SPPB to 3 and 6 months
description: Units on the Scale
measure: Demographic interview and medical history
time frame: Baseline
description: Respond to questions related to demographics and medical history
measure: General cognitive state assessed with Mini Mental State Examination (MMSE)
time frame: Baseline
description: Units on the test: scale range (minimum score = 0 and maximum score = 30). Values between 27 and 30 points are considered as "appropriate cognitive state".
Values between 24 and 26 points are considered as "possible mild cognitive impairment" Values between 0 and 23 points are considered as "possible dementia". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores under 27 will be excluded from the study.
measure: General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)
time frame: Baseline
description: Units on the test: scale range (minimum score = 0 and maximum score = 15). Values between 0 and 5 points are considered as "no depression". Values between 5 and 10 points are considered as "mild depression" Values between 10 and 15 points are considered as "severe depression". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores greater than 5 will be excluded from the study.
arm group label: Multi-domain training
arm group type: Experimental
description: Group that receives cognitive training and physical training
arm group label: Cognitive training
arm group type: Experimental
description: Group that receives cognitive training and physical control activity
arm group label: Physical activity
arm group type: Experimental
description: Group that receives control cognitive activity and physical training
arm group label: Active control
arm group type: Active Comparator
description: Group that receives cognitive control activity and physical control activity
intervention type: Behavioral
intervention name: Cognitive training
description: Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.
arm group label: Cognitive training
arm group label: Multi-domain training
intervention type: Behavioral
intervention name: Physical training
description: Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.
arm group label: Multi-domain training
arm group label: Physical activity
intervention type: Behavioral
intervention name: Cognitive control
description: Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.
arm group label: Active control
arm group label: Physical activity
intervention type: Behavioral
intervention name: Physical control
description: Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.
arm group label: Active control
arm group label: Cognitive training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soledad Ballesteros, PhD
role: Principal Investigator
affiliation: UNED
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional de Educación a Distancia
investigator full name: Soledad Ballesteros
investigator title: Investigator Official Title Ph.D. Emeritus Professor of Psychology
sharing ipd: Undecided