Preventing Loss of Independence Through Exercise (PLIÉ) in Persons With Mild Cognitive Impairment (MCI)
Phase: NA
Conditions: Mild Cognitive Impairment
Sponsor: University of California, San Francisco

 
 
 
NCT03526146 
Preventing Loss of 
Independence 
Through Exercise 
(PLIÉ) in Persons 
With Mild Cognitive 
Impairment (MCI)
Document Date: February 11, 2015 

Data Analysis 
Characteristics of Group 1 and Group 2 were compared using t-tests for continuous variables and Chi-
square tests for categorical variables. Means were calculated for all outcome measures at each of the 
three time points (baseline, 18 weeks, 36 weeks) by group (PLIÉ vs. UC). Our primary outcome was the 
‘between-group’ effect size from baseline to 18 weeks, which was defined as the change in Group 1 
(PLIÉ) minus change in Group 2 (UC) divided by the pooled baseline standard deviation (SD). Signs were 
reversed for measures in which lower scores reflected better outcomes, so that positive values indicate 
greater improvement with PLIÉ and negative values reflect greater improvement with UC. Only those who 
completed assessments at both time points were included in calculations. An effect size of ≥ 0.25 SDs 
was defined as ‘clinically meaningful’ based on prior studies of effect sizes for current dementia 
medications.[5] 
Although there are no well-accepted criteria for defining an effect size as clinically meaningful, an effect 
size ≥0.20 is generally considered small, while an effect size ≥0.50 would be considered medium and an 
effect size ≥0.80 is considered large.[48] To capitalize on the cross-over design, we also calculated 
‘within-group’ effect sizes for both groups, which were defined as change during PLIÉ minus change 
during UC divided by baseline SD. Thus, for Group 1 (PLIÉ first), the within-group effect size was 
calculated as change from baseline to 18 weeks minus change from 18 to 36 weeks divided by baseline 
SD, whereas for Group 2 (UC first), the within-group effect size was calculated as change from 18 to 36 
weeks minus change from baseline to 18 weeks divided by baseline SD. 
Article Source: Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in 
Older Adults with Dementia 
Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, et al. (2015) Preventing Loss of Independence 
through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia. PLOS ONE 10(2): 
e0113367. https://doi.org/10.1371/journal.pone.0113367 

1.0   General Information 
1.1 *Enter the full title of your study: 
Preventing Loss of Independence through Exercise (PLIÉ) 
  
  
1.2 *Enter the study number or study alias 
PLIÉ Project 
  
  
2.0       Add Department(s) 
2.1 List departments and/or research programs associated with this study 
Primary 
Dept? 
Department Name 
● 
UCSF - 101001 - M_Osher Center 
○ 
UCSF - 133144 - M_Psych-LPPI-Core-General 
 
 
3.0       Assign key project personnel(KSP) access to the project 
3.1 *Please add a Principal Investigator for the project: 
Deborah E Barnes 
 
Select if applicable 
□ Department Chair 
□ Fellow 
 
  
3.2 If applicable, please select the Research Staff personnel: 
A) Additional Investigators 
 
 
□ 
Margaret A Chesney  
  
Co-Principal Investigator 
□ 
Wolf E Mehling  
  
Other Investigator 
□ 
Kristine Yaffe  
  
Other Investigator 

B) Research Support Staff 
 
 
□ 
Wendy Santos-Modesitt  
  
Research Assistant 
□ 
Eveline Wu  
  
Research Assistant 
3.3 *Please add a Project Contact: 
01. Deborah E Barnes  
11. Wendy Santos-Modesitt  
 
 
 
The Project Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the 
Principal Investigator themselves). 
 
 
3.4 If applicable, please add a Faculty Advisor/Mentor: 
3.5 If applicable, please select the Designated Department Approval(s): 
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean). 
 
  
4.0   Qualifications of Key Study Personnel 
4.1 List the study responsibilities and qualifications of any individuals who qualify as Key 
Study Personnel (KSP) at UCSF and affiliated sites ONLY by clicking the "Add a new row" 
button: 
  
NOTE: This information is required and your application will be considered incomplete 
without it. 
 KSP Name  
Description of Study 
Responsibilities  
Qualifications  
 
Dr. 
Barnes, 
Deborah 
E, PhD  
 
As PI, Dr. Barnes will 
oversee all aspects of 
study. 
 
Dr. Barnes is an Assoc. Prof of 
Psychiatry at UCSF. Her research 
focuses on identifying risk factors for 
cognitive impairment and dementia 
and conducting clinical trials of 
strategies to enhance cognitive and 
physical function in older adults.  
 

 
Chesney, 
Margaret 
A, PhD  
 
As Co-PI, Dr. Chesney 
will provide senior level 
guidance, particularly 
regarding aspects of the 
project related to 
integrative medicine. 
Dr. Chesney is Director of the Osher 
Center for Integrative Medicine. She 
was the interim director of the 
National Institute for Complementary 
and Integrative Medicine at the NIH 
and involved in its research. 
 
Mehling, 
Wolf E  
 
As Co-Investigator, Dr. 
Mehling will work with 
Dr. Barnes in the 
development and 
implementation of the 
study, particularly 
aspects of the study 
related to integrative 
medicine. 
Dr. Mehling is an Assoc. Prof. of 
Clinical Family and Community 
Medicine and on faculty at the Osher 
Center for Integrative Medicine. His 
research focuses on body-oriented 
complementary therapies and mind-
body interactions. 
 
 
Dr. Yaffe, 
Kristine 
MD  
 
As Co-Investigator, Dr. 
Yaffe will provide 
guidance on 
development and 
implementation of the 
study, particularly 
aspects of the study 
related to working with 
individuals with 
dementia.  
Dr. Yaffe is a Professor of Psychiatry, 
Neurology and 
Epidemiology/Biostatistics at UCSF. 
Her research focuses on 
identification of potentially modiable 
risk factors for cognitive impairment 
and dementia. 
 
 
Santos-
Modesitt, 
Wendy  
 
As a Research Assistant, 
Ms. Santos-Modesitt will 
assist with enrolling, 
scheduling, consenting 
and testing research 
subjects. 
 
Ms. Santos-Modesitt is a graduate 
student in clinical psychology at 
Alliant University. She has been 
working with Dr. Barnes for more 
than a year and has experience 
working with individuals with 
dementia.  
 
Wu, 
Eveline  
 
Ms. Wu will be 
responsible for leading 
the exercise 
intervention with 
oversight from Drs. 
Barnes and Mehling. 
Ms. Wu is a certified Feldenkrais 
instructor with more than 10 years 
of experience working with a wide 
range of clients including older 
adults and special needs children.  
 
5.0   Initial Screening Questions 
5.1 * This study involves human stem cells (including iPS cells and adult stem cells), gametes 
or embryos: 
● No  
○ Yes, and requires CHR and GESCR review  
○ Yes, and requires GESCR review, but NOT CHR review  
 

5.2 * This application involves a Humanitarian Use Device: 
● No  
○ Yes, and it includes a research component  
○ Yes, and it involves clinical care ONLY  
 
5.3 * This is a CIRB study (e.g. the NCI CIRB will be the IRB of record): 
○ Yes ● No  
 
5.4 * This application includes a request to rely on another UC IRB to be the IRB of record: 
○ Yes ● No  
Note: If this request is approved, the CHR will NOT review and approve this study. 
Another UC campus will be the IRB of record. 
 
6.0   Application Type 
6.1 * This research involves: 
● Minimal risk  
○ Greater than minimal risk  
 
6.2 * This application is:  
○ Full Committee  
● Expedited  
○ Exempt  
 
6.3 If you think this study qualifies for expedited review, select the regulatory category(ies) 
that the research falls under: 
□ Category 1: A very limited number of studies of approved drugs and devices 
□ Category 2: Blood sampling 
□ Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail 
clippings, etc.)  
□ Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse 
oximeters, MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.) 
□ Category 5: Research involving materials (data, documents, records, or specimens) 
that were previously collected for either nonresearch or research purposes  
□ Category 6: Use of recordings (voice, video, digital or image) 
■ Category 7: Low risk behavioral research or research employing survey, interview, 
oral history, focus group, program evaluation, human factors evaluation, or quality 
assurance methodologies 
□ Category 8: Continuing review of previously approved full committee research that 
is essentially complete 
■ Category 9: Continuing review of research NOT involving an IND or IDE where the 
IRB has determined that the research poses no greater than minimal risk 
 

6.4 * This study involves: 
● Subject contact (including phone, email or web contact)  
○ No subject contact (limited to medical records review, biological specimen analysis, 
and/or data analysis)  
 
7.0   Funding 
7.1 Identify all sponsors and provide the funding details: 
External Sponsor: 
View 
Details 
Sponsor Name 
Sponsor Type 
Awardee 
Institution 
Contract 
Type: 
UCSF RAS 
"P 
number" 
or 
eProposal 
number  
UCSF 
RAS 
System 
Award 
Numbe
r ("A" 
+ 6 
digits)  
No Sponsor has been added to this Study 
Gift, Program, or Internal Funding (check all that apply): 
■ Funded by gift (specify source below) 
□ Funded by UCSF or UC-wide program (specify source below) 
□ Specific departmental funding (specify source below, if applicable)  
□ Unfunded (miscellaneous departmental funding)  
□ Unfunded student project 
List the gift, program, or departmental funding source: 
Private donation to the Osher Center for Integrative Medicine 
 
7.2 If you tried to add a sponsor in the question above and it was not in the list, follow these 
steps: 
 
If funding has already been awarded or the contract is being processed by the 
Contracts and Grants or Industry Contracts unit, your sponsor is already in 
the system and the project has a UCSF RAS System Proposal or Award 
number. Check with your department's Research Services Analyst (RSA) to ask 
how the sponsor is listed in the UC sponsor list and what the Proposal or Award 
number is. 
  
 
If you need additional assistance, contact the Contracts and Grants Award Team at 
CGAwardTeam@ucsf.edu and list the sponsor in the box below.  
○ Sponsor not in list  
Only if your sponsor is not yet in the list, type the sponsor's name: 
If the funding is administered by the UCSF Office of Sponsored Research, 
your study will not receive CHR approval until the sponsor and funding 
 

details have been added to your application.  
7.3 * This study is supported in whole or in part by Federal funding: 
○ Yes ● No  
If yes, indicate which portion of your grant you will be attaching: 
□ The Research Plan, including the Human Subjects Section of your NIH grant or 
subcontract 
□ For other federal proposals (contracts or grants), the section of the proposal 
describing human subjects work 
□ The section of your progress report if it provides the most current information about 
your human subjects work 
□ The grant is not attached. The study is funded by an award that does not describe 
specific plans for human subjects, such as career development awards (K awards), 
cooperative agreements, program projects, and training grants (T32 awards) 
 
8.0   Statement of Financial Interest 
8.1 * The Principal Investigator and/or one or more of the key study personnel has financial 
interests related to this study: 
○ Yes ● No  
If Yes, attach the Disclosure of Investigators' Financial Interests Supplement to this 
application.  
 
9.0   Sites 
9.1 Institutions (check all that apply): 
■ UCSF  
□ Mt. Zion 
□ San Francisco General Hospital (SFGH) 
□ SF VA Medical Center (SF VAMC) 
□ Helen Diller Family Comprehensive Cancer Center 
□ Blood Centers of the Pacific (BCP) 
□ Blood Systems Research Institute (BSRI) 
□ Fresno (Community Medical Center) 
□ Gallo 
□ Gladstone 
■ Institute on Aging (IOA) 
□ Jewish Home 
□ SF Dept of Public Health (DPH) 
 
9.2 Check all the other types of sites not affiliated with UCSF with which you are cooperating 
or collaborating on this project: 
□ Other UC Campus 
 

□ Other institution 
□ Other community-based site 
□ Foreign Country 
List the foreign country/ies: 
9.3 * This is a multicenter study: 
○ Yes ● No  
 
9.4 Check any research programs this study is associated with: 
□ Cancer Center 
□ Center for AIDS Prevention Sciences (CAPS) 
□ Global Health Sciences 
□ Immune Tolerance Network (ITN) 
■ Osher Center 
□ Positive Health Program 
 
10.0   Study Design 
10.1 * Study design:  
Development (phase 1) and feasibility/pilot testing (phase 2) of an integrative exercise 
intervention to enable individuals with mild-to-moderate dementia to maintain function 
and independence. 
 
10.2 Check all that apply: 
■ Phase I 
□ Phase II 
□ Phase III 
□ Phase IV 
 
11.0   Scientific Considerations 
11.1 Hypothesis: 
This study has a hypothesis: 
○ Yes ● No  
If yes, state the hypothesis or hypotheses: 
 
11.2 * List the specific aims: 
1. To develop and refine PLIÉ (Preventing Loss of Independence through Exercise) in 2 
to 4 individuals with mild-to-moderate dementia. PLIÉ is a novel, integrative exercise 
program designed to help individuals with mild-to-moderate dementia maintain 
independence by integrating elements of traditional strength-building exercises with 
 

Tai Chi, Feldenkrais and yoga (Phase 1). 
 
2. To perform a 36-week pilot test of PLIÉ in approximately 16 individuals with mild-
to-moderate dementia in order to examine issues related to compliance and safety and 
to estimate effect sizes for a larger study (Phase 2). 
11.3 Statistical analysis:  
Because this is a pilot study, statistics will primarily be descriptive and will include 
calculation of means, standard deviations and percentages for demographic 
characteristics and baseline levels of cognitive and physical function. We also will 
calculate change in key measures (paired t-test, McNemar's test) to enable calculation 
of effect sizes and sample size estimates for future projects. 
 
11.4 * This is an investigator-initiated study: 
● Yes ○ No  
 
11.5 This study has received scientific or scholarly review from (check all that apply):  
□ Cancer Center Protocol Review Committee (PRC) (Full approval or contingent PRC 
approval is required prior to final CHR approval for cancer-related protocols.) 
□ CTSI Clinical Research Center (CRC) advisory committee 
□ Departmental scientific review 
□ Other: 
Specify Other: 
If applicable, attach the Departmental Scientific Review Form at the end of the 
application. 
 
12.0   Background 
12.1 Background: 
The dementia epidemic is one of the most important public health issues that our 
nation will face in the coming years. The number of people with Alzheimer‘s disease 
and other dementias in the United States is currently more than 5 million, and a new 
person develops the disease every 72 seconds (1). By 2050, it is anticipated that 10 
million baby boomers will have developed dementia, resulting in a total of 11 to 16 
million cases. The costs of this epidemic—both economically and in terms of the 
suffering of affected individuals and their loved ones—will make dementia one of the 
top health issues facing the nation. 
 
The progressive loss of independence is one of the most difficult aspects of Alzheimer‘s 
disease for both affected individuals and caregivers. We have previously found that 
dependence in one or more basic daily activities is a key predictor of placement in a 
long-term care facility (2). Current drug treatments are associated with small 
improvements in cognitive function but have minimal impact on important outcomes 
such as independence (3). 
 
A handful of small studies have found that exercise interventions improve physical and 
cognitive function in healthy elders (4) and individuals with mild cognitive impairment 
(5). However, surprisingly few studies have examined the effects of exercise in 
individuals with mild to moderate-stage Alzheimer‘s disease (6), particularly  as a 
 

method for maintaining independence. Exercise programs based on Eastern traditions, 
such as Yoga and Tai Chi, have shown encouraging results for physical and emotional 
functioning in the elderly, and improvements in older patients with various chronic 
conditions, including cardiovascular disease (7).  They have rarely been studied in 
patients with dementia, however.  
 
The goal of our study is to develop and pilot-test an integrative exercise program 
specifically designed to help older adults with mild-to-moderate dementia maintain 
independence and function. This program will include traditional strength-building 
exercises targeting the muscles required for basic daily activities as well as elements of 
Tai Chi, Feldenkrais and yoga.  
12.2 Preliminary studies: 
Prior Experience of the Research Team. The research team has previously 
performed a wide range of RCTs of non-pharmacological interventions in a variety of 
study populations and settings including in individuals with cognitive deficits. 
Dr. Deborah Barnes, Associate Professor of Psychiatry (effective 7/1/2011) at UCSF, 
will be PI. Dr. Barnes is an epidemiologist with extensive training in RCT methodology. 
She has recently completed an RCT of computer-based mental activity in individuals 
with mild cognitive impairment (MCI) as well as the Mental Activity and eXercise (MAX) 
Trial—an Alzheimer‘s Association-funded study of the effects of physical and mental 
activity on cognitive function in sedentary elders with cognitive complaints. 
Dr. Kristine Yaffe, Professor of Psychiatry, Neurology and Epidemiology/Biostatistics at 
UCSF, will serve as a Co-Investigator. Dr. Yaffe is an internationally renowned expert 
in cognitive impairment and dementia. She has been PI of several RCTs of 
pharmacological interventions to improve cognitive function and reduce cognitive 
decline in older adults and has also participated in several RCTs of non-pharmacologic 
interventions. 
Dr. Margaret Chesney, Professor of Medicine and Director of the Osher Center for 
Integrative Medicine at UCSF, will serve as Co-Investigator. Dr. Chesney was Deputy 
Director of the National Center of Complimentary and Alternative Medicine at the 
National Institutes of Health for five years (2003-2008) and has extensive knowledge 
of alternative approaches to health and well-being. 
Dr. Wolf Mehling, Associate Professor of Family and Community Medicine at UCSF, will 
serve as Co-Investigator. Dr. Mehling has clinical training and experience with a 
variety of integrative medicine approaches including Feldenkrais, Tai Chi and yoga and 
has completed several RCTs in individuals with cancer and low back pain. 
 
12.3 References: 
1. 2010 Alzheimer's Disease Facts & Figures. 2010. (Accessed January 10, 2011, at 
http://www.alz.org/documents_custom/report_alzfactsfigures2010.pdf.) 
2. Yaffe K, Fox P, Newcomer R, et al. Patient and caregiver characteristics and nursing 
home placement in patients with dementia. Jama 2002;287:2090-7. 
3. O'Brien JT, Burns A. Clinical practice with anti-dementia drugs: a revised (second) 
consensus statement from the British Association for Psychopharmacology. J 
Psychopharmacol 2010;[Epub ahead of print]. 
4. Heyn P, Abreu BC, Ottenbacher KJ. The effects of exercise training on elderly 
persons with cognitive impairment and dementia: a meta-analysis. Arch Phys Med 
Rehabil 2004;85:1694-704. 
5. Lautenschlager NT, Cox KL, Flicker L, et al. Effect of physical activity on cognitive 
function in older adults at risk for Alzheimer disease: a randomized trial. Jama 
 

2008;300:1027-37. 
6. Forbes D, Forbes S, Morgan DG, Markle-Reid M, Wood J, Culum I. Physical activity 
programs for persons with dementia. Cochrane database of systematic reviews 
(Online) 2008:CD006489. 
7. Rogers CE, Larkey LK, Keller C. A review of clinical trials of tai chi and qigong in 
older adults. West J Nurs Res 2009;31:245-79. 
If you have a separate bibliography, attach it to the submission with your other study 
documents.  
13.0   Sample Size and Eligibility 
13.1 Number of subjects that will be enrolled at UCSF and affiliated institutions (locally): 
20 
 
13.2 Total number of subjects that will be enrolled at all sites (for study overall): 
20 
 
13.3 Estimated number of people that you will need to consent and screen here (but not 
necessarily enroll) to get the needed subjects: 
24 
 
13.4 Sample size calculation: 
The primary goal of this pilot study is to assess the safety and feasibility of PLIÉ. As 
described in more detail below, we will begin by beta-testing the program in 2-4 
individuals (Phase 1). We then will pilot-test the program in 16 subjects who will be 
randomized to either Group 1 (intervention) or Group 2 (wait-list control) (Phase 2). 
Sample sizes were based on prior experiences in the field suggesting a maximum class 
size of 8 subjects with mild-to-moderate dementia and 2 instructors. 
 
13.5 * Eligible age range(s): 
□ 0-6 years 
□ 7-12 years 
□ 13-17 years 
■ 18+ years 
 
13.6 Inclusion criteria: 
Primary participant: Age >=55 years, mild-to-moderate dementia (defined as 
physician diagnosis of dementia and Mini-Mental State Examination (MMSE) score of 
10-26), English language fluency, ability to walk independently without a walker or 
cane, physician approval and caregiver consent to participate. 
 
Caregivers: Provide care to primary participant; can provide information about the 
 

primary participant's physical functioning, behaviors, falls, quality of life and own level 
of stress. 
13.7 Exclusion criteria: 
Primary participant: Other neurologic disease (e.g., stroke, Parkinson‘s disease, ALS), 
major current psychiatric illness (e.g., schizophrenia, bipolar disorder), life expectancy 
< 1 year (e.g., metastatic cancer), or inability to assent to study procedures. 
 
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 or 
inability to consent to study procedures. 
 
13.8 There are inclusion or exclusion criteria based on gender, race or ethnicity: 
○ Yes ● No  
If yes, please explain the nature and rationale for the restrictions: 
 
14.0   Drugs and Devices 
14.1 * Drugs or biologics will be studied under this application: 
○ Yes ● No  
 
14.2 * Investigational medical devices or in vitro diagnostics will be used OR approved 
medical devices or in vitro diagnostics will be studied under this application: 
○ Yes ● No  
 
14.3 * A Non-Significant Risk (NSR) determination is being requested for an investigational 
device: 
○ Yes ● No  
 
14.4 Verification of IND/IDE numbers:  If the sponsor’s protocol does not list the IND/IDE 
number, you must submit documentation from the sponsor or FDA identifying the 
IND/IDE number for this study. Attach this documentation in the Other Study 
Documents section of the Initial Review Submission Packet. 
15.0   Other Approvals and Registrations 
15.1 * This is a clinical trial: 
● Yes ○ No  
Clinical Trial Registration 
"NCT" number for this trial: 
Study will be registered and NCT number entered following CHR approval. 
 
15.2 * Data from this study will be submitted to NIH for Genome-Wide Association Studies 

(GWAS): 
○ Yes ● No  
 
15.3 * This study involves vaccines produced using recombinant DNA technologies: 
○ Yes ● No  
 
15.4 * This study involves human gene transfer (NOTE: Requires NIH Recombinant DNA 
Advisory Committee (RAC) review prior to CHR approval): 
○ Yes ● No  
 
15.5 * The study protocol requires radiological procedures (e.g. CT scans, x-rays) or exposes 
subjects to radiation: 
○ Yes ● No  
 
15.6 This study involves other regulated materials and requires approval and/or 
authorization from the following regulatory committees: 
□ Institutional Biological Safety Committee (IBC) 
Specify BUA #: 
□ Institutional Animal Care and Use Committee (IACUC) 
Specify IACUC #: 
□ Radiation Safety Committee 
Specify RUA #: 
□ Radioactive Drug Research Committee (RDRC) 
Specify RDRC #: 
□ Controlled Substances 
 
16.0   Procedures 
16.1 * List all study procedures, test and treatments required for this study: 
1. Recruitment. Primary participants and caregivers will be recruited as dyads from 
the Institute on Aging (IOA) Swindells Center for Adult Day Services, a social day 
program for individuals with mild-to-moderate memory loss. The program runs 
Monday - Friday from 9:30-3:30 and includes meals and transportation to and from 
the participant's home. There are currently approximately 45 clients that attend 2-5 
days/week with 30 attending on a given day. The IOA Director, Dr. David Werdeger, 
and the Swindells Director, Genya Boyko, have both approved use of their clients and 
facilities for this pilot study. 
IOA staff will determine initial eligibility (e.g., primary participant age, diagnosis, 
 

English language fluency, ability to walk) and will contact caregivers of potential 
participants to let them know about the study. A letter will then be sent to caregivers 
of potential participants describing the study and providing an opportunity to learn 
more by returning a form, calling the research study or talking with IOA staff. Those 
caregivers who express interest will be contacted by research staff by phone to further 
assess interest/eligibility and to schedule a consent visit. 
2. Informed consent. As described in more detail below, primary participants and 
caregivers will participate in the consent process together. The consent forms will be 
reviewed and capacity to consent will be assessed in primary participants based on 
responses to questions to determine level of understanding of study procedures, risks, 
benefits and rights. Participants who do not demonstrate capacity to consent will be 
asked to assent to study procedures and caregivers will be asked to consent on their 
behalf. After the consent process has been completed, the Mini-Mental State Exam will 
be administered to primary participants to assess level of cognitive impairment. 
Consent procedures will take place at IOA unless otherwise requested by caregivers. 
3a. Phase 1: Beta-test. Two to 4 participant/caregiver dyads will participate in 
refining the exercise protocol. We have developed PLIÉ in consultation with experts 
worldwide who have experience performing different types of exercises in individuals 
with mild-to-moderate dementia, including traditional strength-building exercises, 
yoga, Tai Chi and Feldenkrais. Specifically, we have identified exercises from each of 
these traditions that engage the muscles most needed to maintain independence--
including lower body strength (to help with getting out of bed/chair), balance (to 
minimize risk of falls), upper body strength (to help with lifting), fine motor exercises 
(to help with activities such as eating and brushing teeth), and pelvic floor exercises 
(to help with continence)--and we have combined them into a unique integrative 
exercise program. These exercises are designed to be purposeful (i.e., to achieve a 
goal) and to build procedural (‗muscle‘) memory. In addition, breathing and guided 
meditation exercises are included to promote relaxation and well-being. 
Because we are combining these exercises in a new way, we feel that it is important 
for us to beta-test and refine the program in a small group of subjects prior to pilot-
testing it in a larger group. The primary goal of the beta-testing phase will be to 
identify a core group of exercises that target the key muscles and movements required 
to maintain functional independence that are safe, fun and meaningful to the 
participants as well as variations of these exercises to accomodate differences in 
baseline functional ability of participants. Classes will occur 2-3 days/week for 30-45 
minutes for 8 weeks. Caregivers will be invited to attend 1 class per month, but this 
will be optional. 
3b. Phase 2: Pilot-test. Participant/caregiver dyads who do not participate in beta-
testing will be invited to participate in the pilot test. These subjects will be randomly 
assigned to either Group 1 (intervention), which will participate first, or Group 2 
(waitlist control group). Group 1 will participate in the PLIÉ program 2-3 days/week for 
30-45 minutes for 18 weeks while Group 2 engages in their usual activities at the day 
care center, which includes a brief daily chair-based exercise session. After Group 1 
has completed their training, Group 2 will participate in the PLIÉ program 2-3 
days/week for 30-45 minutes for 18 weeks. Caregivers will be invited to attend 1 class 
per month, but this will be optional. 
4. Pre- and post-intervention assessment. We will perform a variety of 
standard measures in all participants and caregivers. In the beta-testing group, 
assessments will occur at baseline and after the 8-week training period and will 
primarily be utilized to assess feasibility and logistics of data collection procedures. In 
the pilot-testing group, assessments will be performed at baseline, 18 weeks and 36 
weeks in all participants. Separate appointments will be made for primary participants 
and caregivers to maximize the validity of data collected (e.g., to ensure that 

caregivers do not 'help' primary participants with answers to questions and feel 
comfortable providing information about issues such as difficult behaviors or levels of 
stress). Assessments will take place at IOA unless otherwise requested by caregivers. 
4a. Primary participants. 
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. 
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).  
 
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). 
 
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. 
 
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. 
4b. Caregivers. 
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. 
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). 
 
Participant's falls will be assessed based on caregiver report of number of falls in 
the previous 8 weeks (beta-testing group) or 18 weeks (pilot-testing groups).   
 
Participant's 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. 
 
Participant and caregiver 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.   
 
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). 
 
5. Goal-setting. 
 
Prior to beginning PLIÉ, participants and caregivers will talk with the exercise 
instructor to discuss which daily activities are most meaningful to them and to 
determine whether there are any specific goals related to physical function or daily 
activities that they would like to achieve. The exercise instructor will use this 
information to target exercises toward these goals during training if possible. 
Discussions will be in person with the participant and may be in person or by phone 
with the caregiver. 
6. Compliance and adverse events. Compliance will be assessed based on class 
attendance. Bi-weekly check-in calls will be performed with caregivers to assess for 
adverse events and to address issues related to non-compliance. 
If you have a procedure table, attach it to the submission with your other study 
documents. 
16.2 Interviews, questionnaires, and/or surveys will be administered or focus groups will be 
conducted: 
● Yes ○ No  
List any standard instruments used for this study:   
 
Mini-Mental State Examination (MMSE) (Folstein 1975) 
 
Alzheimer‘s Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) 
scale (Galasko 1997) 
 
Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-cog) 
(Rosen 1984) 
 
Physical Performance Battery (SPPB) (Guralnick 1994) 
 
Neuropsychiatric Inventory (NPI) (Cummings 1997) 
 
Falls Efficacy Scale (FES) (Hauer 2010) 
 
Quality of Life Scale in Alzheimer‘s Disease (QOL-AD) (Logsdon 1999) 
 
SF-36v2 (Stewart 1989) 
 
Caregiver Burden Inventory (CBI) (Novak 1989) 
Attach any non-standard instruments at the end of the application. 
 
16.3 Conduct of study procedures or tests off-site by non-UCSF personnel: 
● Yes ○ No  
If yes, explain: 
Study procedures will be performed at the Institute on Aging's Irene Swindells Center 
for Adult Day Services by UCSF personnel. 
 
16.4 Sharing of experimental research test results with subjects or their care providers: 

○ Yes ● No  
If yes, explain: 
 
16.5 * Specimen collection for future research and/or specimen repository/bank 
administration: 
○ Yes ● No  
 
16.6 Time commitment (per visit and in total): 
Primary participant 
 
Consent/eligibility visit (30-45 minutes) 
 
Baseline assessment (60-90 minutes) 
 
Intervention (30-45 minutes, 2-3 days/week for either 8 weeks (Phase 1 beta-
testing) or 18 weeks (Phase 2 pilot-testing)) 
 
Post-intervention assessments at 18 and 36 weeks (60-90 minutes each) 
 
Total: 12-20 hours over 10 weeks for the beta-testing group; 20-45 hours 
over 40 weeks for pilot-study group 
Caregiver 
 
Consent/eligibility visit (30-45 minutes) 
 
Baseline assessment (60-90 minutes) 
 
Biweekly telephone check-ins (5-10 minutes each) 
 
Post-intervention assessments at 18 and 36 weeks (60-90 minutes each) 
 
Total: 4-6 hours over 10 weeks for the beta-testing group; 5-7 hours over 40 
weeks for pilot-study group 
 
16.7 Locations: 
All study procedures will take place at the Institute on Aging's Irene Swindells Center 
for Adults Day Services in San Francisco. 
 
16.8 Describe the resources in place to conduct this study in a way that assures protection of 
the rights and welfare of participants: 
The safety and welfare of study participants will be ensured by performing all study 
procedures at the IOA, where they are already attending an adult day care program. 
Study personnel who assess for eligibility, obtain consent and administer study 
questionnaires will be extensively trained in how to work with individuals with mild-to-
moderate dementia and caregivers in a sensitive and respectful manner. Class size will 
be limited to 2-4 participants and 1 instructor during beta-testing and 8 participants 
with 2 instructors during pilot-testing to ensure the safety of study participants. 
Exercise instructors will be certified in at least one type of exercise training and will be 
extensively trained in how to safely work with individuals with mild-to-moderate 
dementia. Data will be maintained on secure servers or in locked file cabinets. 
 
17.0   Alternatives 
17.1 Study drug or treatment is available off-study: 

○ Yes  
○ No   
● Not applicable  
 
17.2 * Is there a standard of care (SOC) or usual care that would be offered to prospective 
subjects at UCSF (or the study site) if they did not participate: 
● Yes ○ No  
If yes, describe the SOC or usual care that patients would receive if they choose not to 
participate: 
The adult day health program at IOA currently includes approximately 20 minutes of 
chair-based exercises. These classes will be available to individuals who choose not to 
participate in our study or are assigned to the wait-list control group. 
 
17.3 Describe other alternatives to study participation that are available to prospective 
subjects: 
Subjects could ask their physicians to suggest other exercise programs or could 
engage in similar exercises on their own at home. They also could choose not to 
participate. 
 
18.0   Risks and Benefits 
18.1 * Risks and discomforts: 
As with any program involving new exercises, primary participants may experience 
injuries including muscle strain or soreness, joint pain or fall-related injuries. In 
addition, primary participants or caregivers may find the baseline or follow-up 
assessments to be stressful. Loss to privacy may occur if information is released 
outside the study team. 
 
18.2 Steps taken to minimize risks to subjects: 
We have consulted with a wide range of experts who have experience leading exercise 
classes for individuals with mild-to-moderate dementia to ensure that the PLIE 
exercise program is safe and likely to be effective. These include local, national and 
international experts in traditional exercise programs as well as Tai Chi, Feldenkrais, 
and yoga. We will minimize stress during baseline and post-intervention assessments 
by training research staff to recognize and appropriately address signs of discomfort or 
stress when indicated (e.g., taking breaks, rescheduling appointment, skipping 
sections that cause undue discomfort). We will minimize risk of loss of privacy by 
training all research staff to maintain data in a secure manner and not to discuss study 
participants outside the research team. 
 
18.3 Benefits to subjects: 
● Yes ○ No  
If yes, describe: 
Some primary participants may experience improvements in physical, emotional or 
cognitive function or sleep, but this is not guaranteed. 
 
18.4 Benefits to society: 

We anticipate that findings from this pilot study will be used to support a larger study 
that will determine the efficacy of PLIE for helping individuals with mild-to-moderate 
dementia maintain function and independence. If this program is successful, it could 
substantially improve quality of life for individuals with dementia and their caregivers. 
 
18.5 Explain why the risks to subjects are reasonable:  
The risks to subjects are comparable to daily life experiences related to engaging in 
physical activity or in being assessed in a clinical setting. 
 
19.0   Confidentiality and Privacy 
19.1 Plans for maintaining privacy in the research setting: 
Data will be entered into the MyResearch portal, which provides a secure web-based 
data management and storage system for UCSF investigators. Paper copies of data 
collection forms will be stored in locked files cabinets. Subjects will be identified by a 
unique participant identification number. Personal identifying information will be stored 
separately and securely.  
 
19.2 Possible consequences to subjects resulting from a loss of privacy: 
Loss of privacy could potentially result in stigma related to dementia diagnoses or test 
scores. 
 
19.3 Study data are: 
□ Derived from the Integrated Data Repository (IDR) or The Health Record Data 
Service (THREDS) at SFGH 
□ Derived from a medical record (identify source below) 
□ Added to the hospital or clinical medical record 
□ Created or collected as part of health care 
□ Used to make health care decisions 
■ Obtained from the subject, including interviews, questionnaires 
□ Obtained from a foreign country or countries only 
□ Obtained from records open to the public 
□ Obtained from existing research records 
□ None of the above 
If derived from a medical record, identify source: 
 
19.4 Identifiers may be included in research records: 
● Yes ○ No  
If yes, check all the identifiers that may be included: 
■ Names 
■ Dates 
■ Postal addresses 
■ Phone numbers 
□ Fax numbers 
 

■ Email addresses 
□ Social Security Numbers* 
■ Medical record numbers 
■ Health plan numbers 
□ Account numbers 
□ License or certificate numbers 
□ Vehicle ID numbers 
□ Device identifiers or serial numbers 
□ Web URLs 
□ IP address numbers 
□ Biometric identifiers 
□ Facial photos or other identifiable images 
□ Any other unique identifier 
* Required for studies conducted at the VAMC 
19.5 Identifiable information might be disclosed as part of study activities: 
● Yes ○ No  
If yes, indicate to whom identifiable information may be disclosed: 
□ The subject's medical record 
□ The study sponsor 
□ Collaborators 
□ The US Food & Drug Administration (FDA) 
■ Others (specify below) 
□ A Foreign Country or Countries (specify below) 
If Others, specify: 
Medical personnel if there is a study-related injury. Study auditors. 
 
19.6 Indicate how data are kept secure and protected from improper use and 
disclosure (check all that apply): 
  
NOTE: Whenever possible, do not store subject identifiers on laptops, PDAs, or other 
portable devices. If you collect subject identifiers on portable devices, you MUST encrypt 
the devices. 
■ Data are stored securely in My Research  
□ Data are coded; data key is destroyed at end of study 
■ Data are coded; data key is kept separately and securely  
■ Data are kept in a locked file cabinet 
■ Data are kept in a locked office or suite  
■ Electronic data are protected with a password  
■ Data are stored on a secure network 
■ Data are collected/stored using REDCap or REDCap Survey 
 
19.7 Additional measures to assure confidentiality and protect identifiers from improper use 
and disclosure, if any: 

Research staff are HIPAA-trained and will be instructed not to discuss or disclose 
information about study participants outside the research team. 
 
19.8 This study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action: 
● Yes ○ No  
Explain: 
Interviews with subjects or caregivers could potentially reveal information related to 
abuse or thoughts of suicide or homicide.   
 
19.9 This study will be issued a Certificate of Confidentiality: 
○ Yes ● No  
 
20.0   Subjects 
20.1 Check all types of subjects that may be enrolled: 
□ Inpatients 
□ Outpatients 
■ Healthy volunteers 
□ Staff of UCSF or affiliated institutions 
 
20.2 Additional vulnerable populations: 
□ Children 
□ Subjects unable to consent for themselves 
□ Subjects unable to consent for themselves (emergency setting) 
■ Subjects with diminished capacity to consent 
□ Subjects unable to read, speak or understand English 
□ Pregnant women 
□ Fetuses 
□ Neonates 
□ Prisoners 
□ Economically or educationally disadvantaged persons 
□ Investigators‘ staff  
□ Students 
Explain why it is appropriate to include the types of subjects checked above in this 
particular study: 
The goal of the study is to determine whether the PLIE exercise program enables 
individuals with mild-to-moderate dementia to maintain functional status and 
independence. Therefore, although study participants will have a diminished capacity 
to provide consent, findings from the study could potentially improve quality of life 
for some study participants and provide important data for others with mild-to-
moderate dementia. 
Describe the additional safeguards that have been included in the study to protect the 
rights and welfare of these subjects and minimize coercion or undue influence: 
Informed consent will be obtained from study participants and their caregivers 
 

together. Capacity to consent will be determined using a standard protocol that is 
based on the protocol used at the UCSF Memory and Aging Center. Subjects who are 
able to consent for themselves will do so. Subjects who do not demonstrate capacity to 
consent will be asked for assent and caregivers will provide consent on their behalf.  
21.0   Recruitment 
21.1 * Methods (check all that apply): 
□ Study investigators (and/or affiliated nurses or staff) recruit their own patients 
directly in person or by phone.  
□ Study investigators recruit their own patients by letter. Attach the letter for review. 
□ Study investigators send a ―Dear Doctor‖ letter to colleagues asking for referrals of 
eligible patients. If interested, the patient will contact the PI or the PI may directly 
recruit the patients (with documented permission from the patient). Investigators 
may give the referring physicians a study information sheet for the patients. 
□ Study investigators provide their colleagues with a ―Dear Patient‖ letter describing 
the study. This letter can be signed by the treating physicians and would inform the 
patients how to contact the study investigators. The study investigators may not 
have access to patient names and addresses for mailing 
□ Advertisements, notices, and/or media used to recruit subjects. Interested subjects 
initiate contact with study investigators. Attach ads, notices, or media text for 
review. In section below, please explain where ads will be posted.  
□ Study investigators identify prospective subjects through chart review. (Study 
investigators request a Waiver of Authorization for recruitment purposes.)  
□ Large-scale epidemiological studies and/or population-based studies: Prospective 
subjects are identified through a registry or medical records and contacted by 
someone other than their personal physician. (Study investigators request a Waiver 
of Authorization for recruitment purposes.)  
□ Direct contact of potential subjects who have previously given consent to be 
contacted for participation in research. Clinic or program develops a CHR-approved 
recruitment protocol that asks patients if they agree to be contacted for research (a 
recruitment database) or consent for future contact was documented using the 
consent form for another CHR-approved study.  
□ Study investigators list the study on the School of Medicine list of UCSF Clinical 
Trials website or a similarly managed site. Interested subjects initiate contact with 
investigators. 
□ Study investigators recruit potential subjects who are unknown to them through 
methods such as snowball sampling, direct approach, use of social networks, and 
random digit dialing.  
■ Other  
If Other, explain: 
As described in the Procedures section, IOA staff will assess initial eligibility based on 
factors such as the primary participant's age, diagnosis and ability to walk 
independently. Caregivers of potentially eligible subjects will be contacted by IOA staff 
either in person or by telephone to make them aware of the study and to let them 
know they will be receiving a letter in the mail. Study investigators will then mail a 
letter to caregivers describing the study and providing an opportunity to participate by 
returning a form, calling the research office or telling IOA staff. 
 
21.2 * How, when, and by whom eligibility will be determined: 
Initial eligibility (age, dementia diagnosis, English language fluency, ability to walk 
independently) will be determined by IOA staff. Caregivers who express interest will be 
 

contacted by telephone by research staff to assess initial eligibility criteria. Those meet 
initial criteria will be scheduled for an appointment to obtain written consent and to 
assess other eligiblity criteria (mild-to-moderate stage disease based on Mini-Mental 
State Exam score). 
21.3 * How, when, where and by whom potential subjects will be approached: 
Please see above. 
 
21.4 * Protected health information (PHI) will be accessed prior to obtaining consent: 
● Yes ○ No  
 
22.0   Waiver of Consent/Authorization for Recruitment 
Purposes 
(Note: This section partially replaces the old "Request for Waiver of 
Consent/Authorization for Minimal Risk Research or for Screening for 
Recruitment" supplement form. Please do not attach the old form to 
this application.) 
  
This section is now required when study investigators (and/or 
affiliated nurses or staff) recruit their own patients directly. 
22.1 * Study personnel need to access protected health information (PHI) during the 
recruitment process and it is not practicable to obtain informed consent until potential 
subjects have been identified: 
● Yes  
If no, a waiver of consent/authorization is NOT needed. 
 
22.2 *  A waiver for screening of health records to identify potential subjects poses no more 
than minimal risk to privacy for participants: 
● Yes  
If no, a waiver of authorization can NOT be granted. 
 
22.3 * Screening health records prior to obtaining consent will not adversely affect subjects' 
rights and welfare: 
● Yes  
If no, a waiver of authorization can NOT be granted. 
 
22.4 * Check all the identifiers that will be collected prior to obtaining informed consent: 
■ Names 
■ Dates 
■ Postal addresses 
 

■ Phone numbers 
□ Fax numbers 
□ Email addresses 
□ Social Security Numbers* 
□ Medical record numbers 
□ Health plan numbers 
□ Account numbers 
□ License or certificate numbers 
□ Vehicle ID numbers 
□ Device identifiers or serial numbers 
□ Web URLs 
□ IP address numbers 
□ Biometric identifiers 
□ Facial photos or other identifiable images 
□ Any other unique identifier 
□ None 
Note: HIPAA requires that you collect the minimum necessary. 
22.5 * Describe any health information that will be collected prior to obtaining informed 
consent: 
During the telephone screening process, we will collect data to assess initial eligibility 
criteria including diagnoses of exclusionary medical conditions or contraindications to 
exercise. 
Note: HIPAA requires that you collect the minimum necessary. 
 
22.6 * Describe your plan to destroy the identifiers at the earliest opportunity consistent with 
the research or provide a health or research justification for retaining the identifiers, or 
indicate and explain that retention is required by law: 
PHI for individuals who decline to participate will be retained to ensure that these 
individuals are not contacted inadvertently for future studies. 
 
23.0   Informed Consent  
23.1 * Methods (check all that apply): 
■ Signed consent will be obtained from subjects and/or parents (if subjects are 
minors) 
□ Verbal consent will be obtained from subjects using an information sheet or script 
□ Electronic consent will be obtained from subjects via the web or email 
□ Implied consent will be obtained via mail, the web or email 
■ Signed consent will be obtained from surrogates 
□ Emergency waiver of consent is being requested for subjects unable to provide 
consent  
□ Informed consent will not be obtained 
 
23.2 * Process for obtaining informed consent: 

The participant and caregiver will sit together with research staff during the consent 
process. Research staff will review the key points of the consent documents and will 
ask if the participant or caregiver have any questions. Research staff will then ask 
questions of the participant to assess capacity to consent.  The assessment form is 
included for review. If the participant demonstrates capacity to consent, they will sign 
the consent form; if not, they will be informed that the caregiver is being asked to sign 
on their behalf, and the participant will be asked to assent to study procedures. 
Because caregivers also will be actively participating in the study (by providing 
information about the participant behaviors, stress, etc.), they will sign a separate 
consent form. Finally, research staff will sign both forms and will indicate that an 
assent discussion was completed if appropriate. 
 
23.3 * How investigators will make sure subjects understand the information provided to 
them: 
Research staff will ask participants a series of yes/no questions to assess whether 
consent information was understood. The wording of the questions will be varied to 
ensure that participants cannot simply answer yes or no to all questions. Information 
not understood will be discussed again and understanding will be reassessed. If 
participants are unable to answer any questions after two discussions, they will be 
considered unable to provide consent and will be asked to assent to study procedures 
by agreeing to have their caregiver provide consent on their behalf. Participants who 
are unable to provide either consent or assent will be considered ineligible for the 
study. 
 
24.0   Surrogate Consent 
(Note: This section partially replaces the old "Surrogate 
Consent" supplement form. Please do not attach the old form to this 
application.) 
24.1 Subjects are inpatients on a psychiatric ward or mental health facility, or on psychiatric 
hold: 
● No  
If yes, use of surrogate consent for research is NOT allowed in California. 
 
24.2 This study is related to the cognitive impairment, lack of capacity, or serious or life-
threatening diseases and conditions of the research subjects:  
● Yes  
If no, use of surrogate consent for research is NOT allowed in California. 
 
24.3 Explain why use of surrogates is necessary for completion of this study: 
Purpose of the study is to develop an exercise program that will help to delay loss of 
independence in individuals with mild to moderate dementia.  Consequently, due to 
the nature and purpose of the study, it is likely that some participants may have lost 
their capacity for decision making.  A surrogate may be necessary for multiple 
reasons:  A) to be able to provided consent should it be determined that the study 
participant does not have the capacity to make decisions and B) to provide reliable 
information regarding the participant‘s current level of functioning including mental 
and physical functioning, relevant to the study and C) to provide information on 
caregiver burden resulting from the loss of independence of the participant. 
 

24.4 Plans for assessing the decision-making capacity of prospective subjects: 
1. 
Attempts will be made to obtain informed consent directly from the subject. 
2. 
To ensure the subject has the capacity to consent and is able to directly 
consent, decision making capacity will be assessed by interviewer who will be 
thoroughly trained by the PI. 
3. 
Subject‘s decision making capacity will be assessed by observations made 
during the consent and information sharing process. Observations made will 
be used to assess the subject‘s ability:  
1. 
to make and state a decision and 
2. 
to understand the study objectives, in particular the potential 
participant‘s ability to express his/her own understanding and 
rationale for decisions involving:  
 
The nature of the research and relevant information including 
time in the study and procedures. 
 
Consequences of not participating in the study 
 
Alternatives to participation 
4. 
A Capacity Assessment Record for PLIÉ participants will be used to record the 
capacity to consent and will be kept with the research chart. 
5. 
Should the investigator determine the subject lacks decision making capacity, 
the investigator will inform the participant and seek surrogate consent. 
6. 
Surrogate will then be asked to fill out the Self-Certification of Surrogate 
Decision Maker form.  The form will be kept in the participant‘s research chart. 
7. 
Consent form will be reviewed again with surrogate and participant. 
8. 
Consent will be obtained from surrogate 
9. 
Assent will be obtained from participant 
10. Should the participant not assent, the participant will be excluded from the 
study despite the surrogate‘s consent. 
 
24.5 Plans for obtaining consent from subjects who regain ability to consent after a surrogate 
has given initial consent: 
Dementia progression is typically assessed in clinical and research settings every 6 to 
12 months. Because our study is low-risk and relatively brief (8-36 weeks), we will not 
reassess capacity to consent in participants. However, a subject's resistance or 
objection to engaging in study procedures at any point will be taken as evidence of 
refusal or withdrawal.   
 
24.6 Requirements for any study involving surrogates for obtaining informed consent. Check 
to acknowledge: 
■ Research takes place in California. All surrogates will complete the ―Self-
Certification of Surrogate Decision Makers for Participation in Research‖ form. 
■ Conscious subjects will be notified of the decision to contact a surrogate. If subjects 
object to study participation, they will be excluded even if their surrogate has given 
consent. 
■ Surrogates will not receive any financial compensation for providing consent. 
■ If a higher-ranking surrogate is identified at any time, the investigators will defer to 
the higher-ranking surrogate‘s decision regarding the subject‘s participation in the 
research. 
For research taking place outside of California, explain how investigators will confirm 
that surrogates are legally authorized representatives: 
 
24.7 VA Studies Only 

Provide any additional information to explain comply with the additional VAMC 
requirements for use of surrogates in research: 
 
25.0   Financial Considerations 
25.1 Subjects payment or compensation method (check all that apply): 
Payments will be (check all that apply): 
■ Subjects will not be paid 
□ Cash 
□ Check 
□ Gift card 
□ Other: 
Specify Other: 
 
25.2 Describe the schedule and amounts of payments, including the total subjects can receive 
for completing the study. If deviating from recommendations in Subject Payment 
Guidelines, include specific justification below.  
 
25.3 Costs to Subjects:  Will subjects or their insurance be charged for any study procedures? 
○ Yes ● No  
If yes, describe those costs below, and compare subjects‘ costs to the costs 
associated with alternative care off-study. Finally, explain why it is appropriate to 
charge those costs to the subjects. 
 
26.0   CTSI Screening Questions 
26.1 * This study will be carried out at one of the UCSF Clinical Research Services (CRS) units 
or will utilize CRS services: 
○ Yes ● No  
 
26.2 This project involves community-based research: 
● Yes ○ No  
 
26.3 This project involves practice-based research: 
○ Yes ● No