Movement and Music Intervention for Individuals With Dementia
Phase: NA
Conditions: Dementia With Lewy Bodies, Dementia
Sponsor: Ohio State University

COVER PAGE  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  09/08/2017  
  
  
 
Study Title: Movement and Music Intervention for Dementia  
NCT Number: NCT03121950 
Date of document: September 8, 2017 
 
 

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
Movement and Music Intervention for Dementia  
Deb Kegelmeyer, Anne Kloos, Douglas Scharre  
  
Dementia impacts 5%-7% of individuals >60 years old.[1] It impacts the 
individual’s ability to perform work, care for him/herself and ultimately leads to physical 
disability. There is a high caregiver burden associated with dementia and many 
individuals end their lives in a long-term care facility. Overall caring for individuals with 
dementia is a psychological, physical and financial burden on their loved ones and 
society. Average total cost of care per person with dementia ($287 038) is greater than 
that of person’s with cancer ($173 383).[2] Although Medicare expenditures were similar 
across groups, average out-of-pocket spending for patients with dementia ($61 522) 
was 81% higher than that for individuals without dementia ($34 068).[2]   
  
Best care for individuals with dementia currently involves the use of 
cholinesterase inhibitors to slow cognitive decline. There is no curative therapy and 
most treatments are implemented to manage behavioral symptoms. There is evidence 
in both animal and human studies that exercise modifies metabolic, structural and 
functional dimensions of the brain, even in older adults.[3] Emerging evidence points to 
a protective effect of exercise on cognitive function in those with mild to moderate 
dementia but studies are limited in design and scope and while some show benefit 
others show no impact of exercise on cognition.[3, 4]   
  
Neuroplasticity requires that the correct type and dosage of exercise be applied. 
Research to date has demonstrated that individuals with mild to moderate dementia 
retain the ability to undergo neuroplasticity but the type of exercise and dosage needed 
are not yet clear. Studies have shown that exercise in individuals with dementia can 
lead to improved balance[5], strength and aerobics[6, 7] and function[4-6]. Studies 
showing improved cognitive function included a combination of exercise and an activity 
that was cognitively challenging.[4, 5, 8] Cheng et al. (2014) demonstrated cognitive 
improvement through the use of a cognitively challenging game, Mahjong.[9] In their 
study the group who participated in Tai Chi 3 times a week for 12 weeks did not have a 
slower rate of global deterioration.[9] Two studies demonstrate that optimal benefit may 
be obtained through the use of an exercise intervention that includes cognitively 
challenging activities. Law et al. (2014) had individuals with mild cognitive impairment 
participate in functional task training or in cognitive training alone.[4] Both groups 
demonstrated improved cognitive function but only the functional task training group 
improved in functional status and everyday problem solving activities.[4] Lam et al. 
(2015) compared exercise, cognitive activity or both to demonstrate that the use of both 
exercise and cognitive training is superior to either one alone.[8]   
  
It is recommended that exercise programs be structured, individualized, higher 
intensity, longer duration and multicomponent to bring about improvement in cognitive 

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
function in those with dementia.[3] Due to the current reimbursement market in the 
insurance industry individualized programs are only feasible for a short duration unless 
the individual can pay out of pocket for the program. Compliance can be an issue with 
higher intensity, longer duration programs as demonstrated by the Lam et al. study in 
which 25% of the participants dropped out before the one year intervention ended.[8] 
This study included one hour of exercise 3 times a week for a year which was effective 
but a 25% drop out rate is concerning. The other studies demonstrating improvement in 
cognitive performance in individuals with dementia ranged from 6 – 48 sessions.[4, 5, 9] 
Exercise session length was typically 60 minutes.   
  
Dance is increasingly becoming a popular form of exercise intervention for 
individuals with Parkinson disease (PD)[10-12] and dementia[13-16]. Dance is an 
aerobic exercise that challenges balance and involves functional transitions. In addition 
learning dance sequences is cognitively challenging. Dance is a structured, 
multicomponent exercise that can be higher intensity and thus fulfills the criteria laid out 
by Kirk-Sanchez et al. (2014) of qualities of an exercise program likely to bring about 
change in cognitive function.[3] In individuals with Parkinson disease and dementia it 
has been shown to improve motor function.[10-12, 14-16] In individuals with PD studies 
have shown improvement in cognitive function as measured by MoCA[11, 12], the 
Brooks spatial task[12], reverse corsi block test of working memory,[12], frontal 
assessment battery at bedside and mental rotation task[10]. The only study examining 
impact of dance on cognition in individuals with dementia showed slight improvement in 
mini-mental status exam scores.[16]   
  
Music is an integral part of dancing and as such its impact on cognitive and 
behavioral function must be considered. Studies show that listening to music activates 
specific areas of the brain, most associated with emotional behaviors.[17] Areas 
activated are the insular and cingulate cortex, hypothalamus, hippocampus, amygdala 
and prefrontal cortex.[17] Listening to music has been shown to impact behavior and 
evoke reminiscing in individuals with dementia.[18] Given its potential impact on neural 
function we propose to include a control group who will listen to live music 
performances in a group setting. The control group is proposed to elucidate potential 
benefits of group socialization and music and differentiate these from the potential 
benefits of the dance training.   
  
We hypothesize that a structured dance program involving novelty and learning 
of sequences will improve both motor and cognitive function in individuals with mild to 
moderate dementia greater than a control intervention of social music listening. Aims of 
this study are to investigate the impact of dance training on 1.) Functional movements 
such as sit to stand transfers and walking; 2.) Balance; and 3.) Cognitive function in 
individuals with mild to moderate dementia.   
METHODS  

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
Ninety individuals with a diagnosis of mild to moderate dementia will be recruited to take 
part in the study. Participants will be equally distributed into a dance training group or a 
control group who will listen to music in a group setting. Group placement will alternate 
unless the participant expresses a strong preference to be in a specific group.   
Inclusion Criteria  
Exclusion Criteria  
Diagnosis of dementia (mild to moderate) 
MMSE equivalent score ≥ 10  
Unable to walk 10 feet unassisted  
Age > 60 years old  
Presence of orthopedic disorder that 
impacts walking  
Able to follow simple instructions  
Presence of other neurologic diagnosis 
that impacts cognitive or motor function 
such as stroke, Parkinson disease or 
traumatic brain injury  
  
Enrollment  
Participants will be recruited from local neurology clinics, support groups and senior 
living communities. Potential participants will be told about the study and screened to 
determine if he/she meets inclusion/exclusion criteria using the screening form 
administered by a researcher. After screening the participant will be consented and then 
given the Mini Mental State Exam Equivalent (MMSE equivalent). Individuals with a 
score < 10 (severe dementia) will be disqualified and will not continue in the study.   
Outcome Assessment:  
Participants will be recruited and enrolled until there are 15 participants completed in 
each group. Baseline measures will be assessed by a trained assessor prior to start of 
the intervention (0-2 weeks), intermediate assessment at 6 weeks and post-intervention 
assessment 0-2 weeks after completing the intervention. Assessment will take 60 
minutes and will be conducted either at a senior living community center, or at the 
MEND laboratory in Atwell Hall, Ohio State University.    
Primary Outcome Measures  
• Motor: Timed up and Go cognitive   
The timed up and go cognitive assesses the ability to stand up, walk, turn and sit back 
down while doing a cognitive task. The individual is timed first while doing the task 
without a secondary cognitive task and then while doing the task and counting 
backwards from 100 in increments of 3. It is valid and reliable measure of mobility and 
dual task ability.[19]  
Cognitive: MoCA  

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
The Montreal cognitive assessment is a valid and reliable screening tool for dementia 
that assesses the major cognitive domains. [20] It is a paper test that takes 5 to 10 
minutes to administer.  
Secondary Outcome Measures  
• 
Balance - miniBESTest   
The mini BESTest is a clinical balance assessment tool that aims to target and 
identify 6 different balance control systems that has been shown to be valid and 
reliable in the elderly[21]. It takes 10 – 15 minutes to administer and involves 
tests static and dynamic balance and includes the TUG cognitive.   
• 
Activities and Function - Functional Rating Scale of Symptoms of Dementia (care 
partner fills out)   
A 
scale in which the caregiver rates the ability of the individual with dementia 
to perform daily care activities, memory and sleep.[22]  
• 
Caregiver burden – Caregiver Burden Scale   
A 
survey tool that is a valid and reliable measure to assess perceived 
burden among people caring for others with disabilities.[23]  
  
  
Intervention:  
The dance class will be a 90 minute group class held 2 times per week for 12 weeks. 
Class will consist of seated warm up and stretching routines followed by seated dance 
that becomes progressively more challenging and leads into standing dance activities. 
Each participant will stand behind their chair so that the chair can be used to assist with 
balance. Dance activities initially comprise simple one step moves and progress to more 
complex sequences. Sequences will be carried over session to session to promote 
learning of longer sequences. The dance class will be taught by a trained dance 
instructor who has experience in teaching dance to individuals with neurodegenerative 
diseases.   
The control group will meet one time per week for 90 minutes and will listen to live 
music performances. These performances are held in the community room of a local 
senior care living facility and include residents of the senior care community. Control 
participants will attend with their caregivers and will have opportunity to socialize with 
other study participants as well as members of the senior care community. Music style 
and type varies week to week and is chosen to be appropriate to individuals over 65 
years of age.   
Statistical Analysis:  
We calculated the number needed based on previous studies and arrived at 15 per 
group. Given there is an expectation that some subjects will be found to not meet the 

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
inclusion criteria when given the mini mental status exam equivalent after consenting 
and that some individuals may drop out we are asking for permission to enroll a 
maximum of 45 participants in each group. Once each group has 15 individuals actively 
participating we will stop enrollment  
 A one-way ANOVA will be performed for each outcome variable to estimate differences 
between groups. Where data is nonparametric the Kruskal-Wallis one-way ANOVA will 
be utilized to estimate differences between groups.  Post-hoc Bonferroni comparisons 
with alpha set a priori at p<0.05 will be utilized to determine where there are significant 
differences.  
  
References  
  
1. 
Prince, M., et al., The global prevalence of dementia: a systematic review and 
metaanalysis. Alzheimers Dement, 2013. 9(1): p. 63-75 e2.  
2. 
Kelley, A.S., et al., The burden of health care costs for patients with dementia in the last 
5 years of life. Ann Intern Med, 2015. 163(10): p. 729-36.  
3. 
Kirk-Sanchez, N.J. and E.L. McGough, Physical exercise and cognitive performance in 
the elderly: current perspectives. Clin Interv Aging, 2014. 9: p. 51-62.  
4. 
Law, L.L., et al., Effects of functional tasks exercise on older adults with cognitive 
impairment at risk of Alzheimer's disease: a randomised controlled trial. Age Ageing, 
2014. 43(6): p. 813-20.  
5. 
de Andrade, L.P., et al., Benefits of multimodal exercise intervention for postural control 
and frontal cognitive functions in individuals with Alzheimer's disease: a controlled trial. J 
Am Geriatr Soc, 2013. 61(11): p. 1919-26.  
6. 
Schwenk, M., et al., Improvements in gait characteristics after intensive resistance and 
functional training in people with dementia: a randomised controlled trial. BMC Geriatr, 
2014. 14: p. 73.  
7. 
Antunes, H.K., et al., The influence of physical exercise and leisure activity on 
neuropsychological functioning in older adults. Age (Dordr), 2015. 37(4): p. 9815.  
8. 
Lam, L.C., et al., Would older adults with mild cognitive impairment adhere to and benefit 
from a structured lifestyle activity intervention to enhance cognition?: a cluster 
randomized controlled trial. PLoS One, 2015. 10(3): p. e0118173.  
9. 
Cheng, S.T., et al., Can leisure activities slow dementia progression in nursing home 
residents? A cluster-randomized controlled trial. Int Psychogeriatr, 2014. 26(4): p. 
63743.  
10. 
Hashimoto, H., et al., Effects of dance on motor functions, cognitive functions, and 
mental symptoms of Parkinson's disease: a quasi-randomized pilot trial. Complement 
Ther Med, 2015. 23(2): p. 210-9.  
11. 
Rios Romenets, S., et al., Tango for treatment of motor and non-motor manifestations in 
Parkinson's disease: a randomized control study. Complement Ther Med, 2015. 23(2): p. 
175-84.  
12. 
McKee, K.E. and M.E. Hackney, The effects of adapted tango on spatial cognition and 
disease severity in Parkinson's disease. J Mot Behav, 2013. 45(6): p. 519-29.  

PROTOCOL  
  
IRB Protocol Number:  2016H0211  
 
IRB Approval date:  04/05/2017  
  
  
 
13. 
Kimura, K. and N. Hozumi, Investigating the acute effect of an aerobic dance exercise 
program on neuro-cognitive function in the elderly. Psychology of Sport and Exercise, 
2012. 13(5): p. 623-629.  
14. 
Duignan, D., L. Hedley, and R. Milverton, Exploring dance as a therapy for symptoms 
and social interaction in a dementia care unit. Nurs Times, 2009. 105(30): p. 19-22.  
15. 
Verghese, J., Cognitive and mobility profile of older social dancers. J Am Geriatr Soc, 
2006. 54(8): p. 1241-4.  
16. 
Hokkanen, L., et al., Dance/Movement Therapeutic methods in management of 
dementia. J Am Geriatr Soc, 2003. 51(4): p. 576-7.  
17. 
Boso, M., et al., Neurophysiology and neurobiology of the musical experience. Funct 
Neurol, 2006. 21(4): p. 187-91.  
18. 
Tuckett, A.G., et al., What carers and family said about music therapy on behaviours of 
older people with dementia in residential aged care. Int J Older People Nurs, 2015. 
10(2): p. 146-57.  
19. 
Evans, K., K.M. Refshauge, and R. Adams, Measurement of active rotation in standing: 
reliability of a simple test protocol. Percept. Mot. Skills, 2006. 103(2): p. 619-628.  
20. 
Nasreddine, Z.S., et al., The Montreal Cognitive Assessment, MoCA: a brief screening 
tool for mild cognitive impairment. J Am Geriatr Soc, 2005. 53(4): p. 695-9.  
21. 
Godi, M., et al., Comparison of reliability, validity, and responsiveness of the 
miniBESTest and Berg Balance Scale in patients with balance disorders. Phys Ther, 
2013. 93(2): p. 158-67.  
22. 
Rakel, Conn's Current Therapy. Alzheimer's Disease, ed. T. Hutton. 1990, Philadelphia: 
W.B. Saunders.  
23. 
Macera, C.A., et al., A measure of perceived burden among caregivers. Eval Health 
Prof, 1993. 16(2): p. 205-11.  

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 8 of 17  
Form date: 09/30/14   
  
 
The Ohio State University Consent to Participate in Research 
 
 
Study Title:  
Movement and Music Intervention for Individuals with Dementia 
Principal Investigator: 
Deb Kegelmeyer 
Sponsor:  
Mangurian Foundation 
 
• This is a consent form for research participation.  It contains important information 
about this study and what to expect if you decide to participate.  Please consider the 
information carefully. Feel free to discuss the study with your friends and family and to ask 
questions before making your decision whether or not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what 
decision you make, there will be no penalty to you and you will not lose any of your usual 
benefits.  Your decision will not affect your future relationship with The Ohio State 
University.  If you are a student or employee at Ohio State, your decision will not affect 
your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, as explained 
below, your participation may result in unintended or harmful effects for you that may be 
minor or may be serious depending on the nature of the research. 
• You will be provided with any new information that develops during the study that 
may affect your decision whether or not to continue to participate.  If you decide to 
participate, you will be asked to sign this form and will receive a copy of the form.  You are 
being asked to consider participating in this study for the reasons explained below.   
 
1.   Why is this study being done? 
Dementia impacts 5%-7% of individuals >60 years old. It impacts the person’s ability to 
perform work, care for him/herself and ultimately leads to physical disability. There is a high 
caregiver burden associated with dementia and many individuals require care in a long-term 
care facility. There is some emerging evidence that music based interventions may have a 
protective effect on the brain in those with dementia. There is also evidence that doing 
activities that engage the brain through music are beneficial. This study seeks to investigate the 
potential benefits of a music based intervention for individuals with dementia.  
 
2.   How many people will take part in this study? 
90 individuals with a diagnosis of mild to moderate dementia will be recruited to participate in 
this study 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 9 of 17  
Form date: 09/30/14   
  
3.   What will happen if I take part in this study? 
You will be asked to take a screening test that is a pen and paper test of your memory and 
thinking. If your score is greater than 10 you would be able to continue to participate in the 
study. If your score is less than 10 you would not be able to continue to participate in the study. 
If you meet the criteria to be in the study you will be assessed with pen and paper tests of your 
memory and thinking. You will have your walking, coordination, and mobility assessed. We 
will ask permission from you to interview a study partner or family member who knows you 
well.  This person must be willing to come with you to the study visit to answer questions 
about your thinking and functioning abilities  
 
After the initial assessment you will be assigned to one of two groups. Both groups will 
involve listening to music. You may also be asked to take part in an interactive program with 
the music that would include dance. You will attend class 1 to 2 times per week for 3 months. 
Each session will be 1.5 hours long. Classes will be held at a senior living facility.  
 
You will undergo all of the assessment tests after 6 weeks and again at the end of the study, 
after the 3 month long music based intervention.  
 
4.   How long will I be in the study? 
The study will last for 3 to 4 months. This includes 3 assessments and 3 months of the music 
based intervention. The music based intervention involves 1-2 sessions per week. Each session 
is 1.5 hours long.  
 
 
5. Can I stop being in the study? 
 
You may leave the study at any time.  If you decide to stop participating in the study, there will 
be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.  
Your decision will not affect your future relationship with The Ohio State University.  
 
 
6. What risks, side effects or discomforts can I expect from being in the study? 
There is a risk that you could become tired or have muscle soreness after the class. You will be 
allowed to rest whenever you need to rest. Muscle soreness, if it develops, usually resolves 
within 24 hours. There is a risk that you could fall during the music intervention. There will be 
chairs and trained instructors to minimize this risk.  
 
7. What benefits can I expect from being in the study? 
The music intervention may provide you with entertainment and could be enjoyable. In 
addition, you will be able to socialize with other individuals who have dementia. You may 
obtain some physical conditioning from the music intervention.  
 
8. What other choices do I have if I do not take part in the study? 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 10 of 17  
Form date: 09/30/14   
  
 
You may choose not to participate without penalty or loss of benefits to which you are 
otherwise entitled.  
 
 
9. Will my study-related information be kept confidential? 
 
Efforts will be made to keep your study-related information confidential.  However, there may 
be circumstances where this information must be released.  For example, personal information 
regarding your participation in this study may be disclosed if required by state law.   
 
Also, your records may be reviewed by the following groups (as applicable to the research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors; and 
• 
Your insurance company (if charges are billed to insurance). 
 
If this study is related to your medical care, your study-related information may be placed in 
your permanent hospital, clinic, or physician’s office records. Authorized Ohio State University 
staff not involved in the study may be aware that you are participating in a research study and 
have access to your information.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At most, 
the website will include a summary of the results.  You can search the website at any time.  
 
You may also be asked to sign a separate Health Insurance Portability and Accountability Act 
(HIPAA) research authorization form if the study involves the use of your protected health 
information. 
 
 
10.  What are the costs of taking part in this study? 
 
 
Unless you are a resident of the facility, you will have to travel to and from Parkside Village 
Senior Living (730 N Spring Rd, Westerville, OH 43082) 1-2 times a week for 3.5 months. 
There will be no cost for parking but you will incur costs for gasoline.  
 
11. Will I be paid for taking part in this study? 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 11 of 17  
Form date: 09/30/14   
  
There is no payment for taking part in this study.  
 
 
12. What happens if I am injured because I took part in this study? 
 
If you suffer an injury from participating in this study, you should notify the researcher or study 
doctor immediately, who will determine if you should obtain medical treatment at The Ohio 
State University Wexner Medical Center.   
 
The cost for this treatment will be billed to you or your medical or hospital insurance. The Ohio 
State University has no funds set aside for the payment of health care expenses for this study.  
 
 
13. What are my rights if I take part in this study? 
 
If you choose to participate in the study, you may discontinue participation at any time without 
penalty or loss of benefits.  By signing this form, you do not give up any personal legal rights 
you may have as a participant in this study. 
 
You will be provided with any new information that develops during the course of the research 
that may affect your decision whether or not to continue participation in the study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which you are 
otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio State 
University reviewed this research project and found it to be acceptable, according to applicable 
state and federal regulations and University policies designed to protect the rights and welfare 
of participants in research. 
 
 
14. Who can answer my questions about the study? 
 
For questions, concerns, or complaints about the study you may contact Deb Kegelmeyer 614-
293-0214. 
 
For questions about your rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact Ms. 
Sandra Meadows in the Office of Responsible Research Practices at 1-800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-related 
injury, you may contact Dr. Douglas Scharre, MD at 1-614-293-4969. 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 12 of 17  
Form date: 09/30/14   
  
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this form. 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for subject 
(when applicable) 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given to 
the participant or his/her representative. 
 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 13 of 17  
Form date: 09/30/14   
  
The Ohio State University Consent to Participate in Research 
 
CAREGIVER CONSENT 
Study Title:  
Movement and Music Intervention for Individuals with Dementia 
Principal Investigator: 
Deb Kegelmeyer 
Sponsor:  
Mangurian Foundation 
 
• This is a consent form for research participation.  It contains important information 
about this study and what to expect if you decide to participate.  Please consider the 
information carefully. Feel free to discuss the study with your friends and family and to ask 
questions before making your decision whether or not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what 
decision you make, there will be no penalty to you and you will not lose any of your usual 
benefits.  Your decision will not affect your future relationship with The Ohio State 
University.  If you are a student or employee at Ohio State, your decision will not affect 
your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, as explained 
below, your participation may result in unintended or harmful effects for you that may be 
minor or may be serious depending on the nature of the research. 
• You will be provided with any new information that develops during the study that 
may affect your decision whether or not to continue to participate.  If you decide to 
participate, you will be asked to sign this form and will receive a copy of the form.  You are 
being asked to consider participating in this study for the reasons explained below.   
 
1.   Why is this study being done? 
Dementia impacts 5%-7% of individuals >60 years old. It impacts the person’s ability to 
perform work, care for him/herself and ultimately leads to physical disability. There is a high 
caregiver burden associated with dementia and many individuals require care in a long-term 
care facility. There is some emerging evidence that music based interventions may have a 
protective effect on the brain in those with dementia. There is also evidence that doing 
activities that engage the brain through music are beneficial. This study seeks to investigate the 
potential benefits of a music based intervention for individuals with dementia.  
 
2.   How many people will take part in this study? 
90 individuals with a diagnosis of mild to moderate dementia will be recruited to participate in 
this study. In addition a spouse or caregiver of each individual with dementia will provide 
information for the study.  
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 14 of 17  
Form date: 09/30/14   
  
3.   What will happen if I take part in this study? 
You will be asked to answer questions regarding how well the individual with dementia 
functions at home while performing every day tasks. This is a one page questionnaire. In 
addition you will be asked to fill out a caregiver burden survey to obtain information regarding 
your feelings about caring for an individual with dementia. You will be asked to do these 
assessments 3 times during the study, at the start of the study, 6 weeks into the study and at the 
end of the study.   
 
4.   How long will I be in the study? 
The study will last for 3 to 4 months. This includes 3 assessments. Each assessment will take 
you 5 to 10 minutes.  
 
 
5. Can I stop being in the study? 
 
You may leave the study at any time.  If you decide to stop participating in the study, there will 
be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.  
Your decision will not affect your future relationship with The Ohio State University.  
 
 
6.   What risks, side effects or discomforts can I expect from being in the study? 
We have not identified any risks associated with filling out the questionnaires.  
 
7. What benefits can I expect from being in the study? 
There are no known benefits from filling out the questionnaires.  
 
8.   What other choices do I have if I do not take part in the study? 
 
You may choose not to participate without penalty or loss of benefits to which you are 
otherwise entitled.  
 
 
9.   Will my study-related information be kept confidential? 
 
Efforts will be made to keep your study-related information confidential.  However, there may 
be circumstances where this information must be released.  For example, personal information 
regarding your participation in this study may be disclosed if required by state law.   
 
Also, your records may be reviewed by the following groups (as applicable to the research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 15 of 17  
Form date: 09/30/14   
  
• 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors; and 
• 
Your insurance company (if charges are billed to insurance). 
 
If this study is related to your medical care, your study-related information may be placed in 
your permanent hospital, clinic, or physician’s office records. Authorized Ohio State University 
staff not involved in the study may be aware that you are participating in a research study and 
have access to your information.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At most, 
the website will include a summary of the results.  You can search the website at any time.  
 
You may also be asked to sign a separate Health Insurance Portability and Accountability Act 
(HIPAA) research authorization form if the study involves the use of your protected health 
information. 
 
 
10. What are the costs of taking part in this study? 
 
You may have to drive to and from the dance, music, or assessment sessions at Parkside Village 
Senior Living (730 N Spring Rd, Westerville, OH 43082) 1-2 times a week for 3.5 months. 
There will be no cost for parking but you will incur costs for gasoline.  
 
11. Will I be paid for taking part in this study? 
 
There is no payment for taking part in this study.  
 
 
12. What happens if I am injured because I took part in this study? 
 
If you suffer an injury from participating in this study, you should notify the researcher or study 
doctor immediately, who will determine if you should obtain medical treatment at The Ohio 
State University Wexner Medical Center.   
 
The cost for this treatment will be billed to you or your medical or hospital insurance. The Ohio 
State University has no funds set aside for the payment of health care expenses for this study.  
 
13. What are my rights if I take part in this study? 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 16 of 17  
Form date: 09/30/14   
  
If you choose to participate in the study, you may discontinue participation at any time without 
penalty or loss of benefits.  By signing this form, you do not give up any personal legal rights 
you may have as a participant in this study. 
 
You will be provided with any new information that develops during the course of the research 
that may affect your decision whether or not to continue participation in the study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which you are 
otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio State 
University reviewed this research project and found it to be acceptable, according to applicable 
state and federal regulations and University policies designed to protect the rights and welfare 
of participants in research. 
 
14. Who can answer my questions about the study? 
 
For questions, concerns, or complaints about the study you may contact Deb Kegelmeyer 614-
293-0214. 
 
For questions about your rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact Ms. 
Sandra Meadows in the Office of Responsible Research Practices at 1-800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-related 
injury, you may contact Dr. Douglas Scharre, MD at 1-614-293-4969. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

CONSENT    
 
IRB Protocol Number: 2016H0211 
Biomedical/Cancer  
 
 
 
 
 
 
       IRB Approval date:  09/08/2017 
 
  
 
Version:  3  
  
 
  
Page 17 of 17  
Form date: 09/30/14   
  
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this form. 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for subject 
(when applicable) 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given to 
the participant or his/her representative. 
 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time