Tango for Alzheimer's Disease Patients' Caregivers

Alzheimer's Disease Clinical Trial

Official title:

Effects of Adapted Tango on African-American Women Caregivers of Alzheimer's Disease Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03269149
• Other study ID #: IRB00097348
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center, Emory University, Executive Park, Wesley Woods	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in interleukin-7	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in interleukin-8	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in interleukin-9	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in Interleukin-10	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in interferon induced protein 10	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in macrophage derived chemokine	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in monocyte chemoattractant protein 1	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in transforming growth factor alpha	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in tumor necrosis factor alpha	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in C-reactive protein	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Primary	Change in serum amyloid protein	45 mL blood will be acquired before and after the intervention to measure the inflammatory and stress marker levels	Before and after the intervention / control at least 20 times during 12 weeks
Secondary	Change in Montreal Cognitive Assessment (MoCA)	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).	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in the Tower of London test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in the Stroop interference test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Trails B test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Digit Span test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Buschke Selective Reminding Test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Reverse Corsi Blocks test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Brooks spatial memory test	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in the Body position spatial task (BPST)	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Fullerton Advanced Balance Scale	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).	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in 30-second chair stand	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in gait speed	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Positive Aspects of Caregiving (PAC) Scale	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in Pearlin Caregiver Stress Scale	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in the Zarit Burden Interview	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).	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in the Center for Epidemiologic Studies Depression Scale (CES-D)	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks
Secondary	Change in DEMQOL: Dementia Quality of Life measure (Carer v4)	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.	Before and after the intervention / control, offered twice per week, at least 20 times during 12 weeks