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RECRUITING

NCT04029623

Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

Interventions that affect many different aspects of human ability rather than just one aspect of human health are more likely to be successful in preventing and treating Alzheimer's disease (AD). Functional decline in AD is severely impacted by impaired ability to do physical actions while having to make decisions and concentrating, something scientists call motor-cognitive integration. Combined motor and cognitive training has been recommended for people with early AD, thus this study will use partnered, rhythmic rehabilitation (PRR), as an intervention to simultaneously target cardiovascular, social and motor-cognitive domains important to AD. PRR is moderate intensity, cognitively-engaging social dance that targets postural control systems, involves learning multiple, varied stepping and rhythmic patterns, and fosters tactile communication of motor goals between partners, enhancing social interaction's effect on cognition. Previous research demonstrates that PRR classes are safe and result in no injurious falls. This study is a 12-month long Phase II single- blind randomized clinical trial using PRR in 66 patients with early AD. Participants with early AD will be randomly assigned to participate in PRR or a walking program for three months of biweekly sessions, followed by nine months of weekly sessions of PRR or walking. The overarching hypothesis is that PRR is safe, tolerable and associated with improved motor-cognitive function, and brain (neuronal), vascular (blood vessels) and inflammatory biomarkers that might affect function.

Official title: Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-10-29

Completion Date

2026-07

Last Updated

2025-04-23

Healthy Volunteers

Conditions

Prodromal Alzheimer's Disease

Interventions

OTHER

Partnered Rhythmic Rehabilitation (PRR)

Partnered Rhythmic Rehabilitation (PRR) is moderate intensity, cognitively-engaging social dance that targets postural control systems. PRR involves learning complex stepping patterns and fosters tactile communication of motor goals between partners, enhancing social interaction's effect on cognition. Class sizes will consist of 10 or fewer pairs of participants with pAD and partners to maximize safety. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Classes include practicing previously-learned steps, a 20-minute standing warm-up, and partnering and rhythmic enhancement exercises.

OTHER

Group walking (WALK)

WALK sessions consist of 10 minutes of warm-up, and evaluation/tips for practicing safe walking form mechanics (i.e., head up, shoulders relaxed, abdominals engaged, heel strike, roll and toe off; keep natural stride length, and speed up cadence if increased speed is desired), 55 minutes of walking with breaks, and 20 minutes of balance and stretching. WALK will take place in small groups with research assistants and trained family members and/or caregivers to control for social effects/contact of intervention. Participants of similar walking abilities will be 'buddied' with research assistants and trained physical therapy students who will act as group backmarkers, although participants will lead the pace. WALK participants will keep walking logs documenting their progress. WALK is expected to expend 3 metabolic equivalents (METs), like that of PRR.

Inclusion Criteria: * Amnestic mild cognitive impairment (MCI) will be defined using the AD Neuroimaging Initiative (ADNI) criteria (http://www.adni-info.org/Scientists/ADNIStudyProcedures.aspx). All MCI participants in ADNI are required to have an amnestic subtype defined as: * Subjective memory concern or a memory problem noted by their partner * Abnormal memory function documented by a specified education adjusted cutoff score on the delayed paragraph recall of the Anna Thompson story of the Logical Memory subtest from the Wechsler Memory Scale-Revised * Mini-Mental State Exam (MMSE) score between 24 and 30 (inclusive). Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI * Single or multi-domain amnestic MCI (both subtypes are at high risk for progression to AD) * Clinical Dementia Rating (CDR) = 0.5 (Memory Box score must be at least 0.5) * General functional performance sufficiently preserved * Ability to walk 10 or more feet without an assistive device * Completed six grades of education or has a good work history (sufficient to exclude intellectual disabilities) * Achieves less than 150 minutes of moderate intensity or 75 minutes of vigorous intensity aerobic activity per week, which is the recommended amount of weekly exercise as per the US Department of Health and Human Services. Not involved in any structured exercise program within the past 3 months (brisk walks are considered formal exercise but leisurely walks are not) * Not hospitalized within the last 60 days * Willing to commit to a one year research program Exclusion Criteria: * Acute medical illness requiring hospitalization * Uncontrolled congestive heart failure * History of stroke in the past three years * Inability to perform study procedures * Inability to perform MRI (e.g. metal implants or cardiac pacemaker, claustrophobia) * Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity) * On medications that could adversely affect cognition, eg: antipsychotics, opioids, stimulants, chemotherapy, anti-parkinsonian drugs (eg Levodopa), neurologic prescriptions to treat Multiple sclerosis and/or Parkinson's. Patients will also be excluded if they are not on stable doses of Aricept, or anticholinesterase inhibitors, eg Namenda, for at least 3 months * Psychotic disorders * Confounding neurologic conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae) * Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation

Locations (1)

Emory University

Atlanta, Georgia, United States