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Trial record 13 of 16 for:    CCL22

Tango for Alzheimer's Disease Patients' Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03269149
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Madeleine E. Hackney, Emory University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Adapted Tango Dance Behavioral: Educational lectures Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: Adapted Tango Dance
20 improvisational, 90-minute adapted tango dance sessions over a 12-week period.
Other: Adapted Tango Dance
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.

Active Comparator: Educational Control
Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks.
Behavioral: Educational lectures
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.




Primary Outcome Measures :
  1. Change in interleukin-7 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  2. Change in interleukin-8 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  3. Change in interleukin-9 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  4. Change in Interleukin-10 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  5. Change in interferon induced protein 10 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  6. Change in macrophage derived chemokine [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  7. Change in monocyte chemoattractant protein 1 [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  8. Change in transforming growth factor alpha [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  9. Change in tumor necrosis factor alpha [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  10. Change in C-reactive protein [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels

  11. Change in serum amyloid protein [ Time Frame: Before and after the intervention / control at least 20 times during 12 weeks ]
    45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Change in Trails B test [ Time Frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks ]
    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.

  5. Change in Digit Span test [ Time Frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. 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 ]
    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).

  11. 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 ]
    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.

  12. Change in gait speed [ Time Frame: Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks ]
    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.

  13. 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 ]
    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.

  14. 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 ]
    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.

  15. 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 ]
    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).

  16. 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 ]

    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.


  17. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women family caregivers from the Emory ADRC and Dr. Wharton's studies of Alzheimer's disease (AD) caregivers
  • Parental diagnosis 'probable AD'
  • African-American
  • 45-65 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269149


Contacts
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Contact: Madeleine Hackney, PhD (404) 321-6111 ext 5006 mehackn@emory.edu
Contact: Whitney Wharton, PhD 404-712-7359 w.wharton@emory.edu

Locations
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United States, Georgia
Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods Recruiting
Atlanta, Georgia, United States, 30322
Contact: Madeleine Hackney, MD       mehackn@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Madeleine Hackney School Of Medicine, Emory University

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Responsible Party: Madeleine E. Hackney, Asstant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03269149     History of Changes
Other Study ID Numbers: IRB00097348
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Madeleine E. Hackney, Emory University:
Alzheimer's disease
African-American Women
Caregivers
Tango
Dance-based intervention

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders