Clinical trial NCT01371214: Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot
Official title: Maintaining Independence in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dementia
Keywords: exercise
exercise movement techniques
activities of daily living
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise program called PLIÉ (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and Western exercise traditions and is specifically designed to target the muscles and movements needed to help individuals with mild-to-moderate dementia maintain physical function and independence.


Eligibility criteria: Inclusion Criteria - Primary Participant:

* Current participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
* Recommended by Swindells staff
* mild-to-moderate dementia
* caregiver consent

Inclusion Criteria - Caregiver:

* Provide care to primary participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
* can provide information about the primary participant's physical functioning, behaviors, falls, quality of life and own level of stress.

Exclusion Criteria - Primary Participant:

* major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
* life expectancy \< 1 year (e.g., metastatic cancer)
* inability to assent to study procedures

Exclusion Criteria - Caregiver:

* Any major neurologic disease (e.g., dementia, stroke, Parkinson's disease, ALS)
* major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
* life expectancy \< 1 year (e.g., metastatic cancer)
* evidence of cognitive impairment
* inability to consent to study procedures.

Primary outcomes:
measure: Change in physical function (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in quality of life (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in functional health and well-being (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in number of falls (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in fall-related self-efficacy (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in physical performance (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in cognitive function (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Compliance (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Adverse events (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in dementia-related behaviors (participant)
timeFrame: Baseline, 18 weeks, 36 weeks
Secondary outcomes:
measure: Change in functional health and well-being (caregiver)
timeFrame: Baseline, 18 weeks, 36 weeks
measure: Change in burden (caregiver)
timeFrame: Baseline, 18 weeks, 36 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Irene Swindells Center for Adult Day Services, Institute on Aging
state: California
Study officials:
affiliation: University of California, San Francisco
name: Deborah E Barnes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Margaret Chesney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.