Social IsolationSHAReNCT04281654
Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults
A study testing Active Social Conversation in people with Social Isolation and Mental Status Change, run by George Mason University at 1 site in United States.
Trial summary
The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Mental Status Change, Cognitive Impairment
- What is being tested?
- Active Social Conversation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 26 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be healthy,
- > 65 years of age and able to take part in learning music, or ballroom dance.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hylton Performing Arts Center
Manassas, Virginia, 20110
About this study
Official title: Effects of Arts Engagement Programs on Physical Performance, Cognition, Social Isolation, and Self Perception in Older Adults
The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).
Read the 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.
- Conditions
- Social Isolation, Mental Status Change, Cognitive Impairment, Physical Activity, Quality of Life, Self-Perception
- Being tested
- Active Social Conversation
- Keywords
- Dance, Music, Social Conversation
- Medical subject headings
- Social Isolation, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Social ConversationOther
Also called Active Control
Active Social Conversation
| Study group | Role | What they receive |
|---|---|---|
| Ballroom Dance | Experimental | The Dance group participants will take part in ballroom dance lessons twice/week for 45-minutes/session for 10 weeks Receives: Other: Active Social Conversation |
| Ukulele | Experimental | The Music group participants will take part in ukulele lessons twice/week for 45-minutes/session for 10 weeks Receives: Other: Active Social Conversation |
| Control | Active comparator | 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 Receives: Other: Active Social Conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance using the Short Physical Performance Battery (SPPB)
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.
Measured: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Secondary outcomes (3)
Change in Cognition using Montreal Cognitive Assessment (MOCA) survey
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.
Measured: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Change in Self-Perception Post Intervention Focus Interview
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
Measured: Post 1 (Week 10) and Post 2 (Week 15) Intervention
Change in Social Connections using the Social Connections Survey
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.
Measured: Post 1 (Week 10) and Post 2 (Week 15) Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Sep 2019
- Primary completion25 Apr 2020
- Study completion26 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Sponsor
- Investigators
- Jatin P Ambegaonkar, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281654
- Sponsor's protocol ID
- 1428455-1
- Acronym
- SHARe
- Status last verified
- Feb 2022
- First submitted
- 29 Jul 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Arts Engagement Programs on Physical Performance, Cognition, Social Isolation, and Self Perception in Older Adults
- ClinicalTrials.gov ID
- NCT04281654
- Acronym / sponsor ID
- SHARe / 1428455-1
- Conditions
- Social Isolation, Mental Status Change, Cognitive Impairment, Physical Activity, Quality of Life, Self-Perception
- Keywords
- Dance, Music, Social Conversation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ballroom Dance | Experimental | Other: Active Social ConversationThe Dance group participants will take part in ballroom dance lessons twice/week for 45-minutes/session for 10 weeks |
| Ukulele | Experimental | Other: Active Social ConversationThe Music group participants will take part in ukulele lessons twice/week for 45-minutes/session for 10 weeks |
| Control | Active comparator | Other: Active Social ConversationThe 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 |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Be healthy,
- > 65 years of age and able to take part in learning music, or ballroom dance.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Social ConversationAlso: Active ControlActive Social Conversation | Other | Ballroom Dance, Control, Ukulele |
Primary outcome
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.
3 secondary outcomes
Change in Cognition using Montreal Cognitive Assessment (MOCA) survey
Time frame: 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
Change in Social Connections using the Social Connections Survey
Time frame: Post 1 (Week 10) and Post 2 (Week 15) Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jatin P Ambegaonkar, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Social Conversation in people with Social Isolation and Mental Status Change, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Performance using the Short Physical Performance Battery (SPPB) (time frame: Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.