Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

NCT ID: NCT01371214

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

PLIÉ (Preventing Loss of Independence through Exercise)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

PLIÉ (Preventing Loss of Independence through Exercise)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

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


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Deborah Barnes

Associate Professor, Psychiatry and Epidemiology & Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah E Barnes, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Margaret Chesney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Irene Swindells Center for Adult Day Services, Institute on Aging

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25671576 (View on PubMed)

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.

Reference Type RESULT
PMID: 25022459 (View on PubMed)

Other Identifiers

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10-04080-023906

Identifier Type: -

Identifier Source: org_study_id

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