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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371214
First Posted: June 10, 2011
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deborah Barnes, University of California, San Francisco
  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
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maintaining Independence in Alzheimer's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in physical function (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ]
    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 ]
    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 ]
    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 ]
    Participant's falls will be assessed based on caregiver report.

  • Change in fall-related self-efficacy (participant) [ Time Frame: Baseline, 18 weeks, 36 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).


Enrollment: 12
Study Start Date: June 2011
Study Completion Date: September 2012
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Submitted: June 7, 2011
First Posted: June 10, 2011
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Deborah Barnes, 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
Neurocognitive Disorders
Mental Disorders