Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot - Full Text View

Purpose

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.

Condition	Intervention	Phase
Dementia	Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Maintaining Independence in Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Dementia Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Change in physical function (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Participant's physical function will be assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale (Galasko 1997). The ADCS-ADL is a 78-point scale that assesses functional ability in 23 daily activities based on informant report. It is the standard measure for assessment of functional status in AD treatment trials.
Change in quality of life (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Quality of life will be assessed with the Quality of Life Scale in Alzheimer's Disease (QOL-AD), which is a brief, 13-item measure that obtains input from both the individual and the caregiver (Logsdon 1999). Scores may range from 13-52 points.
Change in functional health and well-being (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Functional health and well-being will be assessed with the SF-36v2, which assesses function in eight domains and provides physical and mental component summary scores that may range from 0 to 70 (Stewart 1989). The SF-36v2 is typically administered directly to participants. However, we also will ask caregivers to answer questions on behalf of participants and will compare their answers to assess congruence. Data collected will help to determine if this measure is suitable for a larger trial.
Change in number of falls (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: Yes ]
Participant's falls will be assessed based on caregiver report.
Change in fall-related self-efficacy (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: Yes ]
Fall-related self-efficacy will be assessed with the Falls Efficacy Scale (FES), which is a 10-item scale that has been validated in individuals with cognitive impairment (Hauer 2010).
Change in physical performance (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Physical performance will be assessed with the Short Physical Performance Battery (SPPB), which was developed by the National Institute on Aging to provide an objective tool for evaluating lower extremity functioning in older adults. The test includes repeated chair stands, tandem balance testing and 8' walking speed (Guralnik 1994).
Change in cognitive function (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Cognitive function will be assessed with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) (Rosen 1984), which is the most commonly used primary outcome measure in AD treatment trials. It is an 80-point scale that includes direct assessment of learning (word list), naming (objects), following commands, constructional Praxis (figure copying), ideational Praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions.
Compliance (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Adverse events (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: Yes ]
Number of adverse events from baseline to 18 weeks and from 18 weeks to 36 weeks will be monitored through biweekly telephone calls with caregivers.
Change in dementia-related behaviors (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Participant's dementia-related behaviors will be assessed with the Neuropsychiatric Inventory (NPI), which is a 144-point informant-based questionnaire that assesses 12 behavioral domains common in dementia including frequency, severity and impact on caregiver distress (Cummings 1997).

Secondary Outcome Measures:

Change in functional health and well-being (caregiver) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Caregivers will be asked about the functional health and well-being of themselves as well as participants using the SF-36v2, which assesses function in eight domains and provides physical and mental component summary scores that may range from 0 to 70 (Stewart 1989).
Change in burden (caregiver) [ Time Frame: Baseline, 18 weeks, 36 weeks ] [ Designated as safety issue: No ]
Caregiver burden will be assessed with the Caregiver Burden Inventory (CBI), which is a 96-point scale that includes 24 items and 5 domains (Novak 1989).

Estimated Enrollment:	16
Study Start Date:	June 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 PLIÉ exercise program 30-45 minutes, 2-3 days/week for 18 weeks followed by 18 weeks of usual care (20-minutes of chair-based exercises 2-5 days/week).	Behavioral: PLIÉ (Preventing Loss of Independence through Exercise) Integrative exercise program that incorporates elements of Eastern and Western exercise traditions to target the muscles and movements needed to help individuals with mild to moderate dementia maintain functional status and independence.
Active Comparator: Group 2 Usual care (20 minutes of chair-based exercises 2-5 days/week) for 18 weeks followed by the PLIÉ exercise program 30-45 minutes/day, 2-3 days/week for 18 weeks.	Behavioral: PLIÉ (Preventing Loss of Independence through Exercise) Integrative exercise program that incorporates elements of Eastern and Western exercise traditions to target the muscles and movements needed to help individuals with mild to moderate dementia maintain functional status and independence.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371214

Locations

United States, California
Irene Swindells Center for Adult Day Services, Institute on Aging
San Francisco, California, United States, 94118

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Deborah E Barnes, PhD, MPH	University of California, San Francisco
Principal Investigator:	Margaret Chesney, PhD	Osher Center for Intergrative Medicine, University of California, San Francisco

More Information

No publications provided

Responsible Party:	Deborah Barnes, Associate Professor, Psychiatry and Epidemiology & Biostatistics, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01371214 History of Changes
Other Study ID Numbers:	10-04080-023906
Study First Received:	June 7, 2011
Last Updated:	April 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

exercise
exercise movement techniques
activities of daily living

Additional relevant MeSH terms:

Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013

Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot (PLIÉ-pilot)