Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease

NCT04029623 | Recruiting

• 2 other identifiers: IRB001103501R01AG062691
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prodromal Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

• Change in Four Square Step Test (FSST) Time

  The Four Square Step Test (FSST) assesses mechanisms underlying motor-cognitive integration. FSST requires participants to step clockwise then counterclockwise into four squares created by rods arranged on the ground in a cross. Participants are instructed to perform FSST "as quickly and as safely as you can," to not touch the rods and make both feet contact the floor in each square. Timing begins when the participant initiates movement and stops when both feet are back in the starting square after completing the sequence. Trials will be repeated if the participant does not understand the instructions, fails to complete the sequence accurately, loses balance, or touches a rod. Three successful trials will be recorded and fastest time selected for analyses.

  Baseline, 3 months, 12 months

• Change in Acceptability

  Acceptability of the intervention will be assessed by conducting two pre-session focus groups with 8-10 pAD participants. Focus groups will assess barriers and facilitators of PRR as therapy for motor-cognitive performance of functional activity issues. Post training, the researchers will conduct two focus groups with 8 participants each to assess satisfaction with PRR, perceived effect of PRR on participation in life's activities, impact of touch on therapy, overall perceived impact of cognitive impairment on benefits/results from PRR, and solicit recommendations for improvement. Responses will be open ended rather than on a pre-determined scale.

  Baseline, Month 12

• Number of Injurious Falls

  The primary safety outcome is the number of injurious falls as a result of participation in PRR. PRR will be considered safe if no injurious falls are observed during PRR instruction.

  Month 12

• Attrition

  Tolerability will be assessed by the number of participants completing the study. PRR will be considered tolerable if attrition is less than or equal to 15 percent.

  Month 12

Secondary Outcomes (20)

• Change in Timed Up and Go (TUG) Test - Cognitive Time

  Baseline, 3 months, 12 months

• Change in Body Position Spatial Task (BPST)

  Baseline, 3 months, 12 months

• Change in Lawton Instrumental Activities of Daily Living (IADL) Score

  Baseline, 3 months, 12 months

• Change in Composite Physical Function (CPF) Scale Score

  Baseline, 3 months, 12 months

• Change in Short Physical Performance Battery (SPPB) Score

  Baseline, 3 months, 12 months

Study Arms (2)

Partnered Rhythmic Rehabilitation (PRR)

EXPERIMENTAL

Participants in this study are will receive the PRR intervention. Participants will have two phases of intervention. In the three-month Training phase, participants will be assigned to 20, biweekly (90-minute) lessons over 12 weeks. In the nine-month Maintenance phase, participants will attend weekly lessons at least 3 times per month.

Other: Partnered Rhythmic Rehabilitation (PRR)

Group walking (WALK)

ACTIVE COMPARATOR

Participants in this study are will receive the WALK intervention. Participants will have two phases of intervention. In the three-month Training phase, participants will be assigned to 20, biweekly (90-minute) lessons over 12 weeks. In the nine-month Maintenance phase, participants will attend weekly lessons at least 3 times per month.

Other: Group walking (WALK)

Interventions

Partnered Rhythmic Rehabilitation (PRR) OTHER

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.

Partnered Rhythmic Rehabilitation (PRR)

Group walking (WALK) OTHER

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.

Group walking (WALK)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Study Officials

• Madeleine Hackney, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Hackney, PhD

CONTACT

404-321-6111; mehackn@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: October 29, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared one year after study publication.
• Access Criteria: Researchers requesting individual participant data will be asked to sign a data use agreement prior to accessing the data. Data can be requested by contacting Dr. Hackney at mehackn@emory.edu

Locations

US (1)