Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

Dementia Clinical Trial

— PLIÉ-pilot  

Official title:

Maintaining Independence in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371214
• Other study ID #: 10-04080-023906
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2011
• Last updated: June 2, 2015
• Start date: June 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Irene Swindells Center for Adult Day Services, Institute on Aging	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIÉ): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113 — View Citation

Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIÉ): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 18 weeks, 36 weeks	No
Primary	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.	Baseline, 18 weeks, 36 weeks	No
Primary	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.	Baseline, 18 weeks, 36 weeks	No
Primary	Change in number of falls (participant)	Participant's falls will be assessed based on caregiver report.	Baseline, 18 weeks, 36 weeks	Yes
Primary	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).	Baseline, 18 weeks, 36 weeks	Yes
Primary	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).	Baseline, 18 weeks, 36 weeks	No
Primary	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.	Baseline, 18 weeks, 36 weeks	No
Primary	Compliance (participant)	Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.	Baseline, 18 weeks, 36 weeks	No
Primary	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.	Baseline, 18 weeks, 36 weeks	Yes
Primary	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).	Baseline, 18 weeks, 36 weeks	No
Secondary	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).	Baseline, 18 weeks, 36 weeks	No
Secondary	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).	Baseline, 18 weeks, 36 weeks	No