<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/NCT02195596</url>
  </required_header>
  <id_info>
    <org_study_id>2011111100</org_study_id>
    <nct_id>NCT02195596</nct_id>
  </id_info>
  <brief_title>Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.</brief_title>
  <acronym>EFA-P</acronym>
  <official_title>Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A program that combines high intensity aerobic exercise (&lt;85% of Heart Rate Reserve) with&#xD;
      resistance, progressive and moderate intensity intervals, carried out in primary care, is&#xD;
      effective in terms of a smaller increase in respect to the baseline measurement in the total&#xD;
      score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in&#xD;
      the control group that receives an intervention similar to low intensity (30-40% of Heart&#xD;
      rate reserve).&#xD;
&#xD;
      We Expect a difference of at least 3 points between the means of the increments between the&#xD;
      intervention and control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVE: To evaluate an intervention that combines high intensity aerobic exercise with&#xD;
      strength (AAAD) on general cognitive performance of patients affected by mild Alzheimer's&#xD;
      disease (AD). DESIGN: Randomized clinical trial in two parallel groups: SCOPE: 2 health&#xD;
      center of Basque Health Service , in coordination with its reference neurology services.&#xD;
      PARTICIPANTS: 80 patients with mild AD.&#xD;
&#xD;
      INTERVENTION: Both groups receiving standard drug treatment. The intervention group also&#xD;
      receive a supervised EEAA program, while the control group receive a similar intervention at&#xD;
      low intensity. Patients are followed up over 1 year. Three blind measurements are made&#xD;
      repeatedly : baseline, at 6 and 12 months. MEASUREMENTS: The primary outcome measure is&#xD;
      change in cognitive performance that is measured in a blinded way with the cognitive section&#xD;
      of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12.Secondary Outcomes:&#xD;
      Global cognitive performance (Neuropsychological battery TBR-B),neuropsychiatric symptoms&#xD;
      (NPI), ADL (Blessed),functional capacity (Test of 6-minute walk), cardiorespiratory Test,&#xD;
      muscular strength (hand dynamometer and trunk); PREDICTORS AND CONFOUNDING VARIABLES:&#xD;
      baseline cognitive performance, previous physical activity, medication, age, sex, APOE,&#xD;
      schooling and cognitive reserve. ANALYSIS: We compared the two groups in terms of observed&#xD;
      mean changes from baseline in ADAS measurement and other variables, intention to treat, using&#xD;
      longitudinal mixed effects models for repeated measures at 6 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12</measure>
    <time_frame>0, 6 and 12 months</time_frame>
    <description>Cognitive performance is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12. ADAS is an instrument designed to assess the severity of cognitive disorders (ADAS-Cog) and noncognitive (ADAS-cog) in patients with Alzheimer-type dementia (ATD). The ADAS-Cog, that we use, consists of 11 items that assess mainly memory (3 items, 27 points), orientation (1 item, 8 points), language (5 items, 25 points) and praxis (2 items, 10 points). The maximum score is 70 points.The higher the score, the greater the cognitive impairment.This is the primary outcome measure most frequently used in clinical trials with drugs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global cognitive performance</measure>
    <time_frame>0, 6 and 12 months</time_frame>
    <description>Global cognitive performance is measured with Test Barcelona TBR-B neuropsychological battery (abreviated version).The ADAS-COG wich is focused on the most devastated areas by Alzheimer's disease, will be complemented by the TBA-B, which has been developed in our environment, makes possible a more global assessment, and also presents adequate psychometric properties.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>neuropsychiatric symptoms and psychopathology</measure>
    <time_frame>0, 6 and 12 months</time_frame>
    <description>NPI will be employed to asses treatment related behavioral changes and the presence of psychopathology in patients receiving exercise</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>High intensity aerobic exercise+strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The program consist in a &quot;Continuous High aerobic exercise and moderate intensity intervals&quot; (ShoshanaB et al, 2012) combined with &quot;muscular strength exercises and joint mobility&quot;. Patients come three times a week for six months to the primary health center. A fitness expert nurse is responsible for monitoring the performance and adapt to the physical condition of the patient.Each exercise session consists of warming up time period, period of work and back to calm. Exercise intensity during the work period increases progressively as the program progresses. Aerobic exercise is performed on a cycle ergometer or treadmill.Muscle strength exercises and joint mobility are performed with dumbbells and ankle weights adapted to each patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low intensity aerobic exercise+strength</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity aerobic exercise+strength</intervention_name>
    <description>The program consist in a &quot;Continuous High aerobic exercise and moderate intensity intervals&quot; (ShoshanaB et al, 2012) combined with &quot;muscular strength exercises and joint mobility&quot;. Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse.</description>
    <arm_group_label>High intensity aerobic exercise+strength</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low intensity aerobic exercise+strength</intervention_name>
    <description>Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.&#xD;
--------------------------------------------------------------------------------</description>
    <arm_group_label>Low intensity aerobic exercise+strength</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Subjects aged between 55 and 85 who meet, at the time of entry into the&#xD;
        study, clinical criteria compatible with probable AD according to the criteria of the&#xD;
        National Institute on Aging and the Alzheimer's Association, under mild or DCL-Alzheimers&#xD;
        (Folstein MMSE&gt; 19/20, GDS 3-4), diagnosis will be performed by specialist neurologists&#xD;
        according to standard practice. Patients should be able to perform physical activity on a&#xD;
        cycle ergometer or treadmill and also must exist a caregiver who agrees to accompany him to&#xD;
        the physical exercise sessions.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Central nervous system disease history with the possibility of&#xD;
        neuropsychological impairment (stroke, epilepsy, meningitis, severe head trauma). History&#xD;
        of alcohol and drug abuse. Hachinski Ischemic Scale ≥ 7. Major depression&#xD;
        diagnosed(CIE-10). History of severe psychiatric disease. Predictable changes in medication&#xD;
        that may affect cognitive performance. Visual or auditory perceptual disorders that limit&#xD;
        neuropsychological assessment. Unstable heart disease, severe behavioral problems that make&#xD;
        impossible the intervention, or any condition judged by the investigator that advises&#xD;
        against the intervention. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ANA DOSIO REVENGA, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Osakidetza</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GONZALO GRANDES ODRIOZOLA, PHD</last_name>
    <phone>0034946006637</phone>
    <email>gonzalo.grandesodriozola@osakidetza.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>MAITE ESPINOSACIFUENTES, MD</last_name>
    <phone>0034946006637</phone>
    <email>maite.espinosacifuentes@osakidetza.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Galdakao Hospital/Galdakao C.S.</name>
      <address>
        <city>Galdakao</city>
        <state>Bilbao</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mª ANGELES GOMEZ BELDARRAIN, PHD</last_name>
      <phone>34 94 400 7234</phone>
      <email>MARIAANGELES.GOMEZBELDARRAIN@osakidetza.net</email>
    </contact>
    <contact_backup>
      <last_name>JAVIER RUIZ OJEDA, PHD</last_name>
      <phone>34 94 400 7234</phone>
      <email>JAVIER.RUIZOJEDA@OSAKIDETZA.NET</email>
    </contact_backup>
    <investigator>
      <last_name>Mª SOLEDAD ARIETALEANIZBEASKOA SARABIA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>ANA DOSIO REVENGA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>AGUSTÍN SASTRE PEREZ</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Basauri C.S.</name>
      <address>
        <city>Basauri</city>
        <state>Bizkaia</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NEREA FONCEA BETI, PHD</last_name>
      <phone>03494 4007234</phone>
      <email>NEREA.FONCEABETI@osakidetza.net</email>
    </contact>
    <investigator>
      <last_name>VERÓNICA ARCE ARANA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>ANGEL FERNÁNDEZ MARTÍNEZ</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>MARÍA CARBALLUDE PRIETO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>IZASKUN GAMBOA AURTENECHE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>JUAN Mª UTERGA VALIENTE, PHD</last_name>
      <phone>944006074</phone>
      <email>JUANMARIA.UTERGAVALIENTE@osakidetza.net</email>
    </contact>
    <investigator>
      <last_name>MAITE ESPINOSA CIFUENTES, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Ana Dosío Revenga</investigator_full_name>
    <investigator_title>Family physician</investigator_title>
  </responsible_party>
  <keyword>Alzheimer disease, exercise, cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02195596
org study id: 2011111100
nct id: NCT02195596
lead sponsor: 
has dmc: Yes
A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with
      resistance, progressive and moderate intensity intervals, carried out in primary care, is
      effective in terms of a smaller increase in respect to the baseline measurement in the total
      score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in
      the control group that receives an intervention similar to low intensity (30-40% of Heart
      rate reserve).

      We Expect a difference of at least 3 points between the means of the increments between the
      intervention and control group.
OBJECTIVE: To evaluate an intervention that combines high intensity aerobic exercise with
      strength (AAAD) on general cognitive performance of patients affected by mild Alzheimer's
      disease (AD). DESIGN: Randomized clinical trial in two parallel groups: SCOPE: 2 health
      center of Basque Health Service , in coordination with its reference neurology services.
      PARTICIPANTS: 80 patients with mild AD.

      INTERVENTION: Both groups receiving standard drug treatment. The intervention group also
      receive a supervised EEAA program, while the control group receive a similar intervention at
      low intensity. Patients are followed up over 1 year. Three blind measurements are made
      repeatedly : baseline, at 6 and 12 months. MEASUREMENTS: The primary outcome measure is
      change in cognitive performance that is measured in a blinded way with the cognitive section
      of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12.Secondary Outcomes:
      Global cognitive performance (Neuropsychological battery TBR-B),neuropsychiatric symptoms
      (NPI), ADL (Blessed),functional capacity (Test of 6-minute walk), cardiorespiratory Test,
      muscular strength (hand dynamometer and trunk); PREDICTORS AND CONFOUNDING VARIABLES:
      baseline cognitive performance, previous physical activity, medication, age, sex, APOE,
      schooling and cognitive reserve. ANALYSIS: We compared the two groups in terms of observed
      mean changes from baseline in ADAS measurement and other variables, intention to treat, using
      longitudinal mixed effects models for repeated measures at 6 and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12
time frame: 0, 6 and 12 months
description: Cognitive performance is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12. ADAS is an instrument designed to assess the severity of cognitive disorders (ADAS-Cog) and noncognitive (ADAS-cog) in patients with Alzheimer-type dementia (ATD). The ADAS-Cog, that we use, consists of 11 items that assess mainly memory (3 items, 27 points), orientation (1 item, 8 points), language (5 items, 25 points) and praxis (2 items, 10 points). The maximum score is 70 points.The higher the score, the greater the cognitive impairment.This is the primary outcome measure most frequently used in clinical trials with drugs.
measure: Global cognitive performance
time frame: 0, 6 and 12 months
description: Global cognitive performance is measured with Test Barcelona TBR-B neuropsychological battery (abreviated version).The ADAS-COG wich is focused on the most devastated areas by Alzheimer's disease, will be complemented by the TBA-B, which has been developed in our environment, makes possible a more global assessment, and also presents adequate psychometric properties.
measure: neuropsychiatric symptoms and psychopathology
time frame: 0, 6 and 12 months
description: NPI will be employed to asses treatment related behavioral changes and the presence of psychopathology in patients receiving exercise
arm group label: High intensity aerobic exercise+strength
arm group type: Experimental
description: The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center. A fitness expert nurse is responsible for monitoring the performance and adapt to the physical condition of the patient.Each exercise session consists of warming up time period, period of work and back to calm. Exercise intensity during the work period increases progressively as the program progresses. Aerobic exercise is performed on a cycle ergometer or treadmill.Muscle strength exercises and joint mobility are performed with dumbbells and ankle weights adapted to each patient.
arm group label: Low intensity aerobic exercise+strength
arm group type: Active Comparator
description: The control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR).
intervention type: Other
intervention name: High intensity aerobic exercise+strength
description: The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse.
arm group label: High intensity aerobic exercise+strength
intervention type: Other
intervention name: Low intensity aerobic exercise+strength
description: Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.
--------------------------------------------------------------------------------
arm group label: Low intensity aerobic exercise+strength
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: ANA DOSIO REVENGA, PHD
role: Principal Investigator
affiliation: Osakidetza
last name: GONZALO GRANDES ODRIOZOLA, PHD
phone: 0034946006637
email: gonzalo.grandesodriozola@osakidetza.net
last name: MAITE ESPINOSACIFUENTES, MD
phone: 0034946006637
email: maite.espinosacifuentes@osakidetza.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Ana Dosío Revenga
investigator title: Family physician
mesh term: Alzheimer Disease
mesh term: Dementia