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Completed

NCT Number: NCT01371214

Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Irene Swindells Center for Adult Day Services, Institute on Aging

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PLIÉ (Preventing Loss of Independence through Exercise)

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in number of falls (participant)

    Time frame: Baseline, 18 weeks, 36 weeks

    Participant's falls will be assessed based on caregiver report.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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 outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Maintaining Independence in Alzheimer's Disease

Acronym: PLIÉ-pilot

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2011
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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