- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281654
Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults (SHARe)
Effects of Arts Engagement Programs on Physical Performance, Cognition, Social Isolation, and Self Perception in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this Randomized-Controlled-Trial, 60 adults (20/condition) will take part in 20, 45-minute sessions (ballroom dance, ukulele/guitar playing, or control- i.e. social conversation), 2 times/week for 10 weeks.
While the investigators know that arts participation improves function in older adults, exact effects of different arts programs on health outcomes remains unclear.
The investigators plan to fill this gap by studying how different arts participation affect health outcomes.
The overall aim is to study how arts engagement helps older adults remain active and influences physical, psychological, and emotional functioning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Manassas, Virginia, United States, 20110
- Hylton Performing Arts Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be healthy,
- > 65 years of age and able to take part in learning music, or ballroom dance.
Exclusion Criteria:
- Presence of a co-morbid mental health diagnosis or other physical or behavioral challenges that the study staff assess as rendering the participant unable or unsafe to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ballroom Dance
The Dance group participants will take part in ballroom dance lessons twice/week for 45-minutes/session for 10 weeks
|
Active Social Conversation
Other Names:
|
|
EXPERIMENTAL: Ukulele
The Music group participants will take part in ukulele lessons twice/week for 45-minutes/session for 10 weeks
|
Active Social Conversation
Other Names:
|
|
ACTIVE_COMPARATOR: Control
The Control group participants will meet 2 times per week for 45-minutes/session for 10 weeks to participate in a social conversational group for 10 weeks
|
Active Social Conversation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Performance using the Short Physical Performance Battery (SPPB)
Time Frame: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
The Short Physical Performance Battery (SPPB) is an assessment tool for evaluation of lower extremity functioning in older persons.
In this tool, participants will perform the 3 SPPB components: 1) Ability to stand for 10 sec with feet in 3 different positions (together side-by-side, semi-tandem, and tandem), 2) Two timed trials of a 4-m walk (fastest recorded), and 3) Time to rise from a chair five times.
The subtests are scored from 0-4.
The overall SPPB is scored from 0 (Minimum) to 12 (Maximum score) with higher scores indicating better lower extremity function.
|
Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognition using Montreal Cognitive Assessment (MOCA) survey
Time Frame: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
The Montreal Cognition Assessment (MoCA) is a brief, 30-question test designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
MoCA scores range between 0-30.
A score of 26 or over is considered normal.
|
Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
|
Change in Self-Perception Post Intervention Focus Interview
Time Frame: Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
In these interviews participants discuss how they self-perceive any physical, mental, and social changes they underwent as a result of taking part in the interventions
|
Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
|
Change in Social Connections using the Social Connections Survey
Time Frame: Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
Participants complete questions from the National Social Life, Health, and Aging Project (NSHAP) measure perceived social connection and isolation.
These questions ask participants about 1) Support from partner (we are using 3 of the 6 questions); 2) Support from family (we are using 3 of the 5 questions); 3) Support from friends (we are using 3 of the 5 questions).
All questions are on a 4-point frequency range from "never" to "often", except for 2 questions.
Question #1 construct one is on a 7-point scale from "very unhappy to "very happy" and question #5 construct two is on a 6-point scale from "none" to "more than 20".
The 7 items with the same frequency anchors will be summed; the other two items will be analyzed as one-item indicators.
|
Post 1 (Week 10) and Post 2 (Week 15) Intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jatin P Ambegaonkar, PhD, George Mason University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1428455-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
Clinical Trials on Active Social Conversation
-
Stanford UniversityRecruitingAutism Spectrum DisorderUnited States
-
Lauren Van ScoyPenn State University; University of Kentucky; Francis Family FoundationCompletedChronic Disease | Caregivers
-
Karina Lopes DevitoEnrolling by invitationSocial Media | Dental Education and Teaching Learning ProcessesBrazil
-
Oregon Health and Science UniversityNational Institute on Aging (NIA)CompletedCognitive Change | Mild Cognitive ImpairmentUnited States
-
University of Sao PauloUnknownSchizophrenia and Disorders With Psychotic FeaturesBrazil
-
Frederiksberg University HospitalDepartment of Psychology and Behavioural Sciences, Aarhus UniversityCompletedKnee OsteoarthritisDenmark
-
UMC UtrechtDimence GroepRecruitingAutism Spectrum Disorder (ASD) | NeurotypicalNetherlands
-
Nottingham University Hospitals NHS TrustCompletedPhysical Activity | Moving Medicine | Acute Medical UnitUnited Kingdom
-
Virginia Commonwealth UniversityNational Institute on Drug Abuse (NIDA)CompletedSubstance UseUnited States
-
University of AarhusDanish Cancer Society; TrygFonden, DenmarkUnknownHeart Failure | Neoplasms | Pulmonary DiseaseDenmark