<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/NCT03269149</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00097348</org_study_id>
    <nct_id>NCT03269149</nct_id>
  </id_info>
  <brief_title>Tango for Alzheimer's Disease Patients' Caregivers</brief_title>
  <official_title>Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The goal of the project is to determine the extent to which indices of inflammatory&#xD;
      biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs&#xD;
      control condition in African American (AA) female family caregivers, at high risk for&#xD;
      Alzheimer's disease (AD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The importance of informal family caregiving in Alzheimer's disease (AD) is well-established.&#xD;
      African-American caregivers are most often middle aged adult children of AD patients (vs.&#xD;
      spouses), women, and are at higher risk for chronic health problems. AD lifestyle&#xD;
      interventions offer an alternative to medication, and are generally affordable, accessible,&#xD;
      and adaptable to the lives of caregivers. To date, most non-pharmaceutical interventions have&#xD;
      focused on exercise and nutrition, both of which have proven to be highly successful in&#xD;
      conferring AD related benefits and decreasing AD risk.&#xD;
&#xD;
      The goal of the project is to determine the extent to which indices of inflammatory&#xD;
      biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs&#xD;
      control condition in African American (AA) female family caregivers, at high risk for&#xD;
      Alzheimer's disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in interleukin-7</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interleukin-8</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interleukin-9</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Interleukin-10</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interferon induced protein 10</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in macrophage derived chemokine</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in monocyte chemoattractant protein 1</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in transforming growth factor alpha</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in tumor necrosis factor alpha</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in C-reactive protein</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum amyloid protein</measure>
    <time_frame>Before and after the intervention / control at least 20 times during 12 weeks</time_frame>
    <description>45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The MoCA test is a 30-point test that assesses several cognitive domains. The short-term memory recall task (5 points) ; Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point); executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). Language is assessed using a confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Tower of London test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Tower of London test is used for the assessment of executive functioning specifically to detect deficits in planning. It is related to the classic problem-solving puzzle known as the Tower of Hanoi.The test consists of two boards with pegs and several beads with different colors. The examiner uses the beads and the boards to present the examinee with problem-solving tasks. The performance of the examinee is compared to representative samples of individuals of the same age to derive hypotheses about the person's executive cognitive ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Stroop interference test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Stroop test is to name the color in which a word is printed, ignoring the word itself. The Stroop Test is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the imultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Total time needed for each card is the outcome variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Trails B test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>Trail Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric.The test is sensitive to detecting cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Digit Span test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Digit Span test is either conducted verbally or using a computer program. A sequence of numbers is shown or read out to the participant. The participant is then told to repeat the numbers that were shown or read to them. This process continues until the participant can no longer remember either the full sequence of numbers or the correct order.The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. The scorer must add the total number of correct sequences, backwards and forwards.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Buschke Selective Reminding Test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Buschke Selective Reminding Test (SRT) is a test designed to measure verbal learning and memory through the use of a list-learning procedure over multiple trials. The adult SRT involves reading the subject a list of 12 unrelated words and then having the subject immediately recall as many of these 12 words as possible. Every trial after the first involves selectively presenting only those words in which the subject did not recall on the immediately preceding trial. The selective reminding trials proceed in this manner until the subject is able to correctly recall all 12 words on three consecutive trials, or until 12 trials have been completed. Scoring of the test has been automated according the instructions of Buschke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Reverse Corsi Blocks test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. It involves mimicking a researcher as he/she taps a sequence of up to nine identical spatially separated blocks. The sequence starts out simple, usually using two blocks, but becomes more complex until the subject's performance suffers. This number is known as the Corsi Span, and averages about 5 for normal human subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Brooks spatial memory test</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>Brooks spatial memory task (BSMT): In the BSMT, the participant visualizes a 4x4 matrix in which the location of numbers 1 through 8 is described. Participants practice with 3 instructions and progress up to 8 instructions. All levels are completed regardless of errors. Percentages correct (out of 50) will be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Body position spatial task (BPST)</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>Body position spatial task (BPST) measures whole body knowledge of spatial position and ability to navigate in a remembered path. The examiner verbally and visually demonstrates combinations of 5 possible moves: step forward, step left, step right, quarter turn left, and quarter turn right. The examiner begins with 2 moves and progresses up to 9 moves, with 2 trials per level. Participants continue to the next level if one trial is correctly performed. The test ends when participants miss both trials of a level. Span length and number of correct trials are variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fullerton Advanced Balance Scale</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Fullerton Test is mainly intended to identify highly-active older adults who are at an increased risk to experience fall-related injuries due to sensory impairments. The test uses both dynamic and static balance under different situations to identify balance deficits in older adults. The test includes the following: 10 performance based activities in both static and dynamic phases; Score of 0-40/40 points possible (higher scores are better); tems scored on a 5 point ordinal scale (0-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 30-second chair stand</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The 30 second chair test is administered using a folding chair without arms, with seat height of 17 inches (43.2 cm). The 30 second chair stand involves recording the number of stands a person can complete in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gait speed</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>Assesses walking speed in meters per second over a short duration . The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Positive Aspects of Caregiving (PAC) Scale</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The 9-item PAC scale will be administered to the caregivers. Each item is scored on a 5-point Likert scale: disagree a lot (1), disagree a little (2), neither agree nor disagree (3), agree a little (4), and agree a lot (5). The overall PAC score, comprising all nine items, ranges from 9 to 45-a higher score reflects a more positive perception of the caregiving experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pearlin Caregiver Stress Scale</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>Pearlin Caregiver Stress Scale topics include primary stressors (cognitive status, problematic behavior, overload, relational deprivation), secondary role strains family conflict, job-caregiving conflict, economic strains), secondary instrapsychic strains (role captivity, loss of self, caregiving competence, personal gain) and mediators (management of situation, management of meaning, management of distress, expressive support). Fifteen 3-point to 5-point scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Zarit Burden Interview</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The Zarit Burden Interview, a caregiver self-report measure is a 22-item self-report inventory that examines burden associated with functional/behavioral impairments and the home care situation. Each question is scored on a 5 point Likert scale ranging from 0 (Never) to 4 (Nearly Always).. Total scores range from 0 (low burden) to 88 (high burden).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>The CESD-R is a screening test for depression and depressive disorder. The 20 items in CESDR scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association. The response values for each question are:&#xD;
Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 4 The Total CESD-R Score is calculated as a sum of responses to all 20 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DEMQOL: Dementia Quality of Life measure (Carer v4)</measure>
    <time_frame>Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks</time_frame>
    <description>DEMQOL is a 29-item scale, plus one global item (&quot;Overall, how would you rate your quality of life?&quot;) that measures 5 domains of QOL: Positive Affect (6 items), Negative Affect (11 items), Feelings of Belonging (3 items), Self-esteem (4 items), and Sense of Aesthetics (5 items). The DQoL yields scores on 5 subscales but subscale scores are not summed to reach an overall or global measure of QOL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Adapted Tango Dance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 improvisational, 90-minute adapted tango dance sessions over a 12-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adapted Tango Dance</intervention_name>
    <description>20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged.</description>
    <arm_group_label>Adapted Tango Dance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational lectures</intervention_name>
    <description>Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q&amp;A will be encouraged.</description>
    <arm_group_label>Educational Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's&#xD;
             disease (AD) caregivers&#xD;
&#xD;
          -  Parental diagnosis 'probable AD'&#xD;
&#xD;
          -  African-American&#xD;
&#xD;
          -  45-65 years of age&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madeleine Hackney</last_name>
    <role>Principal Investigator</role>
    <affiliation>School Of Medicine, Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Madeleine Eve Hackney</investigator_full_name>
    <investigator_title>Asstant Professor</investigator_title>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <keyword>African-American Women</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Tango</keyword>
  <keyword>Dance-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03269149/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03269149
org study id: IRB00097348
nct id: NCT03269149
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of the project is to determine the extent to which indices of inflammatory
      biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs
      control condition in African American (AA) female family caregivers, at high risk for
      Alzheimer's disease (AD).
The importance of informal family caregiving in Alzheimer's disease (AD) is well-established.
      African-American caregivers are most often middle aged adult children of AD patients (vs.
      spouses), women, and are at higher risk for chronic health problems. AD lifestyle
      interventions offer an alternative to medication, and are generally affordable, accessible,
      and adaptable to the lives of caregivers. To date, most non-pharmaceutical interventions have
      focused on exercise and nutrition, both of which have proven to be highly successful in
      conferring AD related benefits and decreasing AD risk.

      The goal of the project is to determine the extent to which indices of inflammatory
      biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs
      control condition in African American (AA) female family caregivers, at high risk for
      Alzheimer's disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in interleukin-7
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in interleukin-8
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in interleukin-9
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in Interleukin-10
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in interferon induced protein 10
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in macrophage derived chemokine
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in monocyte chemoattractant protein 1
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in transforming growth factor alpha
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in tumor necrosis factor alpha
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in C-reactive protein
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in serum amyloid protein
time frame: Before and after the intervention / control at least 20 times during 12 weeks
description: 45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels
measure: Change in Montreal Cognitive Assessment (MoCA)
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The MoCA test is a 30-point test that assesses several cognitive domains. The short-term memory recall task (5 points) ; Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point); executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration and working memory are evaluated using a attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). Language is assessed using a confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. Finally, orientation to time and place is evaluated (6 points).
measure: Change in the Tower of London test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Tower of London test is used for the assessment of executive functioning specifically to detect deficits in planning. It is related to the classic problem-solving puzzle known as the Tower of Hanoi.The test consists of two boards with pegs and several beads with different colors. The examiner uses the beads and the boards to present the examinee with problem-solving tasks. The performance of the examinee is compared to representative samples of individuals of the same age to derive hypotheses about the person's executive cognitive ability.
measure: Change in the Stroop interference test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Stroop test is to name the color in which a word is printed, ignoring the word itself. The Stroop Test is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the imultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Total time needed for each card is the outcome variable.
measure: Change in Trails B test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: Trail Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric.The test is sensitive to detecting cognitive impairment.
measure: Change in Digit Span test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Digit Span test is either conducted verbally or using a computer program. A sequence of numbers is shown or read out to the participant. The participant is then told to repeat the numbers that were shown or read to them. This process continues until the participant can no longer remember either the full sequence of numbers or the correct order.The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. The scorer must add the total number of correct sequences, backwards and forwards.
measure: Change in Buschke Selective Reminding Test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Buschke Selective Reminding Test (SRT) is a test designed to measure verbal learning and memory through the use of a list-learning procedure over multiple trials. The adult SRT involves reading the subject a list of 12 unrelated words and then having the subject immediately recall as many of these 12 words as possible. Every trial after the first involves selectively presenting only those words in which the subject did not recall on the immediately preceding trial. The selective reminding trials proceed in this manner until the subject is able to correctly recall all 12 words on three consecutive trials, or until 12 trials have been completed. Scoring of the test has been automated according the instructions of Buschke.
measure: Change in Reverse Corsi Blocks test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Corsi block-tapping test is a psychological test that assesses visuo-spatial short term working memory. It involves mimicking a researcher as he/she taps a sequence of up to nine identical spatially separated blocks. The sequence starts out simple, usually using two blocks, but becomes more complex until the subject's performance suffers. This number is known as the Corsi Span, and averages about 5 for normal human subjects.
measure: Change in Brooks spatial memory test
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: Brooks spatial memory task (BSMT): In the BSMT, the participant visualizes a 4x4 matrix in which the location of numbers 1 through 8 is described. Participants practice with 3 instructions and progress up to 8 instructions. All levels are completed regardless of errors. Percentages correct (out of 50) will be used for analysis.
measure: Change in the Body position spatial task (BPST)
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: Body position spatial task (BPST) measures whole body knowledge of spatial position and ability to navigate in a remembered path. The examiner verbally and visually demonstrates combinations of 5 possible moves: step forward, step left, step right, quarter turn left, and quarter turn right. The examiner begins with 2 moves and progresses up to 9 moves, with 2 trials per level. Participants continue to the next level if one trial is correctly performed. The test ends when participants miss both trials of a level. Span length and number of correct trials are variables.
measure: Change in Fullerton Advanced Balance Scale
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Fullerton Test is mainly intended to identify highly-active older adults who are at an increased risk to experience fall-related injuries due to sensory impairments. The test uses both dynamic and static balance under different situations to identify balance deficits in older adults. The test includes the following: 10 performance based activities in both static and dynamic phases; Score of 0-40/40 points possible (higher scores are better); tems scored on a 5 point ordinal scale (0-4).
measure: Change in 30-second chair stand
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The 30 second chair test is administered using a folding chair without arms, with seat height of 17 inches (43.2 cm). The 30 second chair stand involves recording the number of stands a person can complete in 30 seconds.
measure: Change in gait speed
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: Assesses walking speed in meters per second over a short duration . The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.
measure: Change in Positive Aspects of Caregiving (PAC) Scale
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The 9-item PAC scale will be administered to the caregivers. Each item is scored on a 5-point Likert scale: disagree a lot (1), disagree a little (2), neither agree nor disagree (3), agree a little (4), and agree a lot (5). The overall PAC score, comprising all nine items, ranges from 9 to 45-a higher score reflects a more positive perception of the caregiving experience.
measure: Change in Pearlin Caregiver Stress Scale
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: Pearlin Caregiver Stress Scale topics include primary stressors (cognitive status, problematic behavior, overload, relational deprivation), secondary role strains family conflict, job-caregiving conflict, economic strains), secondary instrapsychic strains (role captivity, loss of self, caregiving competence, personal gain) and mediators (management of situation, management of meaning, management of distress, expressive support). Fifteen 3-point to 5-point scales.
measure: Change in the Zarit Burden Interview
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The Zarit Burden Interview, a caregiver self-report measure is a 22-item self-report inventory that examines burden associated with functional/behavioral impairments and the home care situation. Each question is scored on a 5 point Likert scale ranging from 0 (Never) to 4 (Nearly Always).. Total scores range from 0 (low burden) to 88 (high burden).
measure: Change in the Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: The CESD-R is a screening test for depression and depressive disorder. The 20 items in CESDR scale measure symptoms of depression in nine different groups as defined by the American Psychiatric Association. The response values for each question are:
Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 4 The Total CESD-R Score is calculated as a sum of responses to all 20 questions.
measure: Change in DEMQOL: Dementia Quality of Life measure (Carer v4)
time frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
description: DEMQOL is a 29-item scale, plus one global item ("Overall, how would you rate your quality of life?") that measures 5 domains of QOL: Positive Affect (6 items), Negative Affect (11 items), Feelings of Belonging (3 items), Self-esteem (4 items), and Sense of Aesthetics (5 items). The DQoL yields scores on 5 subscales but subscale scores are not summed to reach an overall or global measure of QOL.
arm group label: Adapted Tango Dance
arm group type: Experimental
description: 20 improvisational, 90-minute adapted tango dance sessions over a 12-week period.
arm group label: Educational Control
arm group type: Active Comparator
description: Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks.
intervention type: Other
intervention name: Adapted Tango Dance
description: 20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged.
arm group label: Adapted Tango Dance
intervention type: Behavioral
intervention name: Educational lectures
description: Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q&A will be encouraged.
arm group label: Educational Control
criteria: 
gender: Female
gender based: Yes
gender description: Females
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Madeleine Hackney
role: Principal Investigator
affiliation: School Of Medicine, Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Madeleine Eve Hackney
investigator title: Asstant Professor
mesh term: Alzheimer Disease
provided document: 