Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers (PairedPLIE)

NCT02403752 | Completed

• 1 other identifier: 14-14943
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for ambulatory individuals with dementia and caregivers living at home based on recruitment, adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT) with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and regular home practice or wait list in a cross-over design. Investigators will assess feasibility of enrollment and retention, the proportion of completed outcome measures, and adherence by class attendance logs, caregiver-reported home practice logs and qualitative interviews to assess ease of implementation in the home environment. Investigators will explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit accelerometers as a measure for tracking home practice. Specific Aim 2: To collect preliminary effect size data for sample size calculation for a larger trial. Investigators will assess standard outcomes (such as the Short Physical Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20 dyads of the RCT described in Specific Aim 1. Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change. Investigators will compare brain oxygenation variations before and after the exercise intervention during a memory task for the seniors with dementia.

Conditions

Dementia; Alzheimer's Disease

Keywords

dementia; Alzheimer's disease; exercise

Outcome Measures

Primary Outcomes (2)

• Change in Short Physical Performance Battery (SPPB) from Baseline to 4 months

  We will perform a variety of standard measures in all participants and caregivers. Assessments will occur at baseline, after the 4 months of intervention, and at 8 months after follow-up of 4 months. Outcomes will primarily be utilized to assess feasibility and logistics of data collection procedures.

  Baseline, post-intervention (4 months)

• Change in Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) from baseline to 4 months

  We will perform a variety of standard measures in all participants and caregivers. Assessments will occur at baseline, after the 4 months of intervention, and at 8 months after follow-up of 4 months. Outcomes will primarily be utilized to assess feasibility and logistics of data collection procedures.

  Baseline, post-intervention (4 months)

Secondary Outcomes (2)

• Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD) from baseline to 4 months

  Baseline, post-intervention (4 months)

• Change in Caregiver Burden Inventory (CBI) from baseline to 4 months

  Baseline, post-intervention (4 months)

Study Arms (1)

exercise intervention

EXPERIMENTAL

Exercise protocol based on the PLIÉ protocol, developed in consultation with experts worldwide, incl. traditional strength-building exercises, yoga, Tai Chi and Feldenkrais, that engage the muscles most needed to maintain independence--including lower body strength, balance, upper body strength, fine motor exercises , and pelvic floor exercises- combined them into a unique integrative exercise program, to be purposeful and to build procedural ('muscle') memory. To be practiced at home in dyads of affected individuals and caregivers, called Paired PLIE Program.

Behavioral: Paired PLIE Program

Interventions

Paired PLIE Program BEHAVIORAL

Integrative exercise as described above

exercise intervention

Eligibility Criteria

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

You may qualify if:

• Affected individuals: dementia diagnosis (any type, mild to moderate severity \[defined as independent in at least 1 basic ADL\])
• Ambulatory and able to take 2 steps without cane or walker
• Living in the community in a private home or apartment
• English language fluency.
• Caregiver/care partner: lives with affected individual
• Motivated to practice regularly (4-5 times per week) at home
• Able to answer study questions related to the affected individual's functional status, mood, behaviors, quality of life and their own feelings regarding caregiving
• English language fluency.

You may not qualify if:

• Affected Individuals: behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
• Planning to move to a facility before the end of the study period
• Terminal illness (life expectancy \< 1 year)
• Non-stable dementia medication dose
• Current participation in another research study.
• Caregiver/care partner: planning to place affected individual in an institutional setting during the study period
• Terminal illness (life expectancy \< 1 year)
• Behavioral or physical issues that are disruptive or dangerous.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Permanente: collaborator

Study Sites (1)

UCaliforniaSF

San Francisco, California, 94115, United States

Location

Related Publications (13)

• Alzheimer's Association. 2013 Alzheimer's disease facts and figures. Alzheimers Dement. 2013 Mar;9(2):208-45. doi: 10.1016/j.jalz.2013.02.003.

  PMID: 23507120 BACKGROUND

• Acosta D, Wortmann M. World Alzheimer Report: Alzheimer's Disease International. 2009

  BACKGROUND

• Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629.

  PMID: 23550670 BACKGROUND

• Rockwood K. Size of the treatment effect on cognition of cholinesterase inhibition in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2004 May;75(5):677-85. doi: 10.1136/jnnp.2003.029074.

  PMID: 15090558 BACKGROUND

• Olazaran J, Reisberg B, Clare L, Cruz I, Pena-Casanova J, Del Ser T, Woods B, Beck C, Auer S, Lai C, Spector A, Fazio S, Bond J, Kivipelto M, Brodaty H, Rojo JM, Collins H, Teri L, Mittelman M, Orrell M, Feldman HH, Muniz R. Nonpharmacological therapies in Alzheimer's disease: a systematic review of efficacy. Dement Geriatr Cogn Disord. 2010;30(2):161-78. doi: 10.1159/000316119. Epub 2010 Sep 10.

  PMID: 20838046 BACKGROUND

• Beeber AS, Thorpe JM, Clipp EC. Community-based service use by elders with dementia and their caregivers: a latent class analysis. Nurs Res. 2008 Sep-Oct;57(5):312-21. doi: 10.1097/01.NNR.0000313500.07475.eb.

  PMID: 18794715 BACKGROUND

• Yao L, Giordani BJ, Algase DL, You M, Alexander NB. Fall risk-relevant functional mobility outcomes in dementia following dyadic tai chi exercise. West J Nurs Res. 2013 Mar;35(3):281-96. doi: 10.1177/0193945912443319. Epub 2012 Apr 19.

  PMID: 22517441 BACKGROUND

• Deweer B, Ergis AM, Fossati P, Pillon B, Boller F, Agid Y, Dubois B. Explicit memory, procedural learning and lexical priming in Alzheimer's disease. Cortex. 1994 Mar;30(1):113-26. doi: 10.1016/s0010-9452(13)80327-9.

  PMID: 8004981 BACKGROUND

• Zeller JB, Herrmann MJ, Ehlis AC, Polak T, Fallgatter AJ. Altered parietal brain oxygenation in Alzheimer's disease as assessed with near-infrared spectroscopy. Am J Geriatr Psychiatry. 2010 May;18(5):433-41. doi: 10.1097/JGP.0b013e3181c65821.

  PMID: 20220582 BACKGROUND

• Markovich NIa, Proskuriakova AM. [Discovery of Anopheles messeae Fall. breeding sites at the Sayan reservoir and in the tailrace of the Yenisei in the construction area of Sayan-Shushenskoe hydroelectric station]. Med Parazitol (Mosk). 1986 Jan-Feb;(1):10-3. No abstract available. Russian.

  PMID: 3959992 BACKGROUND

• Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.

  PMID: 25022459 RESULT

• Barnes DE, Mehling W, Wu E, Yaffe K, Flores C, Chesney M. Preventing Loss of Independence through Exercise (PLIÉ): An Integrative Exercise Program for Individuals with Dementia. American Academy of Neurology; March 20, 2013, 2013; San Diego, CA

  RESULT

• Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.

  PMID: 25671576 RESULT

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Wolf E Mehling, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)