<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/NCT01681602</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2011-128</org_study_id>
    <nct_id>NCT01681602</nct_id>
  </id_info>
  <brief_title>Effect of Physical Exercise in Alzheimer Patients</brief_title>
  <acronym>ADEX</acronym>
  <official_title>Preserving Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: The Effect of Physical Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only&#xD;
      temporarily slow down progression.&#xD;
&#xD;
      Exercise has the potential to improve cognition, psychological symptoms, physical performance&#xD;
      and quality of life, but evidence is scarce. Previous trials are short, often underpowered&#xD;
      and involving home based light exercise programs. Most have included nursing homes residents&#xD;
      with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise&#xD;
      is effective in improving cognition, physical performance and quality of life as well as&#xD;
      reducing the prevalence of psychological symptoms among AD patients.&#xD;
&#xD;
      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on&#xD;
      power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90&#xD;
      years with mild to moderate AD. The participants will be randomly allocated into two groups:&#xD;
      An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise&#xD;
      1 hour three times a week and a control group only receiving usual care. The hypothesis is&#xD;
      that aerobic exercise will improve physical function, the cognitive and daily functioning and&#xD;
      quality of life in people with mild to moderate AS.&#xD;
&#xD;
      Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup&#xD;
      of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural&#xD;
      changes and β-amyloid accumulation.&#xD;
&#xD;
      Further, a health-economic analysis will be performed.&#xD;
&#xD;
      Recruitment was started in January 2012. Last study visits are planned to be performed in&#xD;
      January 2014 and results will be available in 2014. This RCT will contribute to evidence&#xD;
      regarding the potential effects of a systematic program of physical exercise for patients&#xD;
      with Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see protocol article&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symbol Digit Modalities Test</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>NPI (psychological symptoms.)</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Astrand submaximal bicycle test for estimating VO2 max</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro-qol-5D-5L (health related quality of life)</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog).</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical fitness</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
    <description>Timed up and go test (TUG), 10 m walk, 10m Dual-Task, 400m fast walking, Sit-to-stand (number in 30 sec.)(STS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy scale</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal fluency</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MMSE (Mini Mental State Examination)</measure>
    <time_frame>Change in score from baseline to 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16 weeks of aerobic exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Endurance training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria are (table 1)&#xD;
&#xD;
          -  Age between 50 and 90 years&#xD;
&#xD;
          -  A score of 20 or more on the Mini Mental State Examination (MMSE)&#xD;
&#xD;
          -  Imaging (CT or MR of cerebrum) consistent with AD&#xD;
&#xD;
          -  Have a caregiver with regular contact to the participant (more than once a month) who&#xD;
             is also willing to participate in the study&#xD;
&#xD;
          -  In general good health allowing the participant to participate in physical exercise.&#xD;
&#xD;
          -  At least 7 years of schooling and Danish speaking&#xD;
&#xD;
          -  Visual acuity and hearing must permit neuropsychological testing.&#xD;
&#xD;
          -  If the patient is receiving anti-dementia medication or mood stabilizing medication,&#xD;
             these must have been given in stable doses for at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in aerobic exercise (moderate to hard intensity) more than 2 times a&#xD;
             week on a regular basis.&#xD;
&#xD;
          -  Any musculoskeletal or joint impairment that could interfere with completion of the&#xD;
             study (significant joint problems, back pain or pain in arms and legs that provide&#xD;
             problems with mobility in daily activities)&#xD;
&#xD;
          -  Male participants with a combination of two or more of the following risk factors even&#xD;
             if asymptomatic: smokers, hypertension and hypercholesterolemia&#xD;
&#xD;
          -  Major neurologic (other than AD), cardiac or other medical diseases that constitutes a&#xD;
             contraindication to physical activity. Stent operation or previous myocardial&#xD;
             infarction is not an exclusion criteria if the participant has had a recent (within 3&#xD;
             months) normal exercise tests .&#xD;
&#xD;
          -  Severe cerebro vascular disease judged from the CT or MR scans and remarkable&#xD;
             hypertension defined as Systolic blood pressure &gt;180 and diastolic &gt;100&#xD;
&#xD;
          -  Severe psychiatric disease, as well as alcohol or drug abuse within the last 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steen G Hasselbalch, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>April 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>November 28, 2014</last_update_submitted>
  <last_update_submitted_qc>November 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Steen G Hasselbalch</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Alzheimer Disease</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cognition</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cardiovascular fitness</keyword>
  <keyword>Behavioural or psychological symptoms</keyword>
  <keyword>Physical fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT01681602
org study id: H-3-2011-128
nct id: NCT01681602
lead sponsor: 
has dmc: Yes
Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only
      temporarily slow down progression.

      Exercise has the potential to improve cognition, psychological symptoms, physical performance
      and quality of life, but evidence is scarce. Previous trials are short, often underpowered
      and involving home based light exercise programs. Most have included nursing homes residents
      with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise
      is effective in improving cognition, physical performance and quality of life as well as
      reducing the prevalence of psychological symptoms among AD patients.

      Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on
      power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90
      years with mild to moderate AD. The participants will be randomly allocated into two groups:
      An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise
      1 hour three times a week and a control group only receiving usual care. The hypothesis is
      that aerobic exercise will improve physical function, the cognitive and daily functioning and
      quality of life in people with mild to moderate AS.

      Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup
      of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural
      changes and β-amyloid accumulation.

      Further, a health-economic analysis will be performed.

      Recruitment was started in January 2012. Last study visits are planned to be performed in
      January 2014 and results will be available in 2014. This RCT will contribute to evidence
      regarding the potential effects of a systematic program of physical exercise for patients
      with Alzheimer's disease.
see protocol article
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Symbol Digit Modalities Test
time frame: Change in score from baseline to 16 weeks
measure: NPI (psychological symptoms.)
time frame: Change in score from baseline to 16 weeks
measure: Astrand submaximal bicycle test for estimating VO2 max
time frame: Change in score from baseline to 16 weeks
measure: Euro-qol-5D-5L (health related quality of life)
time frame: Change in score from baseline to 16 weeks
measure: Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog).
time frame: Change in score from baseline to 16 weeks
measure: Changes in physical fitness
time frame: Change in score from baseline to 16 weeks
description: Timed up and go test (TUG), 10 m walk, 10m Dual-Task, 400m fast walking, Sit-to-stand (number in 30 sec.)(STS).
measure: Self-efficacy scale
time frame: Change in score from baseline to 16 weeks
measure: Verbal fluency
time frame: Change in score from baseline to 16 weeks
measure: Stroop
time frame: Change in score from baseline to 16 weeks
measure: MMSE (Mini Mental State Examination)
time frame: Change in score from baseline to 16 weeks
arm group label: Intervention group
arm group type: Active Comparator
description: 16 weeks of aerobic exercise
arm group label: Control group
arm group type: No Intervention
description: Usual care.
intervention type: Other
intervention name: Aerobic exercise
description: Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.
arm group label: Intervention group
other name: Endurance training
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Steen G Hasselbalch, Professor
role: Principal Investigator
affiliation: Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Steen G Hasselbalch
investigator title: Associate Professor
mesh term: Alzheimer Disease