search
Back to results

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

Primary Purpose

Dementia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PLIÉ (Preventing Loss of Independence through Exercise)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring exercise, exercise movement techniques, activities of daily living

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Irene Swindells Center for Adult Day Services, Institute on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in physical function (participant)
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)
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)
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)
Participant's falls will be assessed based on caregiver report.
Change in fall-related self-efficacy (participant)
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)
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)
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)
Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Adverse events (participant)
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)
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)
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)
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).

Full Information

First Posted
June 7, 2011
Last Updated
June 2, 2015
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT01371214
Brief Title
Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot
Acronym
PLIÉ-pilot
Official Title
Maintaining Independence in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
exercise, exercise movement techniques, activities of daily living

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PLIÉ (Preventing Loss of Independence through Exercise)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical function (participant)
Description
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.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in quality of life (participant)
Description
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.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in functional health and well-being (participant)
Description
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.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in number of falls (participant)
Description
Participant's falls will be assessed based on caregiver report.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in fall-related self-efficacy (participant)
Description
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).
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in physical performance (participant)
Description
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).
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in cognitive function (participant)
Description
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.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Compliance (participant)
Description
Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Adverse events (participant)
Description
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.
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in dementia-related behaviors (participant)
Description
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).
Time Frame
Baseline, 18 weeks, 36 weeks
Secondary Outcome Measure Information:
Title
Change in functional health and well-being (caregiver)
Description
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).
Time Frame
Baseline, 18 weeks, 36 weeks
Title
Change in burden (caregiver)
Description
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).
Time Frame
Baseline, 18 weeks, 36 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah E Barnes, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Chesney, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irene Swindells Center for Adult Day Services, Institute on Aging
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25671576
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.
Results Reference
result
PubMed Identifier
25022459
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.
Results Reference
result

Learn more about this trial

Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

We'll reach out to this number within 24 hrs