DementiaPhase 1PLIÉ-pilotNCT01371214
Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot
A Phase 1 study testing PLIÉ (Preventing Loss of Independence through Exercise) in people with Dementia, run by University of California, San Francisco at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- PLIÉ (Preventing Loss of Independence through Exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Irene Swindells Center for Adult Day Services, Institute on Aging
San Francisco, California, 94118
About this study
Official title: Maintaining Independence in Alzheimer's Disease
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.
- Conditions
- Dementia
- Being tested
- PLIÉ (Preventing Loss of Independence through Exercise)
- Keywords
- exercise, exercise movement techniques, activities of daily living
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLIÉ (Preventing Loss of Independence through Exercise)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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). Receives: Behavioral: PLIÉ (Preventing Loss of Independence through Exercise) |
| Group 2 | Active comparator | 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. Receives: Behavioral: PLIÉ (Preventing Loss of Independence through Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 18 weeks, 36 weeks
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.
Measured: Baseline, 18 weeks, 36 weeks
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.
Measured: Baseline, 18 weeks, 36 weeks
Change in number of falls (participant)
Participant's falls will be assessed based on caregiver report.
Measured: Baseline, 18 weeks, 36 weeks
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).
Measured: Baseline, 18 weeks, 36 weeks
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).
Measured: Baseline, 18 weeks, 36 weeks
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.
Measured: Baseline, 18 weeks, 36 weeks
Compliance (participant)
Participant compliance will be determined based on % of exercise classes attended from baseline to 18 weeks and from 18-36 weeks.
Measured: Baseline, 18 weeks, 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.
Measured: Baseline, 18 weeks, 36 weeks
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).
Measured: Baseline, 18 weeks, 36 weeks
Secondary outcomes (2)
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).
Measured: Baseline, 18 weeks, 36 weeks
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).
Measured: Baseline, 18 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Barnes, University of California, San Francisco
- Investigators
- Deborah E Barnes, PhD, MPH, Principal investigator, University of California, San FranciscoMargaret Chesney, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371214
- Sponsor's protocol ID
- 10-04080-023906
- Acronym
- PLIÉ-pilot
- Status last verified
- Jun 2015
- First submitted
- 7 Jun 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25671576Wu 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.
PubMed 25022459
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Independence in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01371214
- Acronym / sponsor ID
- PLIÉ-pilot / 10-04080-023906
- Conditions
- Dementia
- Keywords
- exercise, exercise movement techniques, activities of daily living
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)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 2 | Active comparator | Behavioral: PLIÉ (Preventing Loss of Independence through Exercise)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 1, Group 2 |
Primary outcome
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).
2 secondary outcomes
Change in functional health and well-being (caregiver)
Time frame: Baseline, 18 weeks, 36 weeks
Change in burden (caregiver)
Time frame: Baseline, 18 weeks, 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Results publication: PubMed 25671576Barnes 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 publication: PubMed 25022459Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah E Barnes, PhD, MPH principal investigator
University of California, San Francisco
Margaret Chesney, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLIÉ (Preventing Loss of Independence through Exercise) in people with Dementia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical function (participant) (time frame: Baseline, 18 weeks, 36 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371214, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.