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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04281654
Other study ID # 1428455-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date April 26, 2020

Study information

Verified date February 2022
Source George Mason University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, & Aging Project-NSHAP survey), and perceptions of self (focus interviews).


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 26, 2020
Est. primary completion date April 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility 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 Design


Intervention

Other:
Active Social Conversation
Active Social Conversation

Locations

Country Name City State
United States Hylton Performing Arts Center Manassas Virginia

Sponsors (2)

Lead Sponsor Collaborator
George Mason University National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Secondary 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. Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention
Secondary 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 Post 1 (Week 10) and Post 2 (Week 15) Intervention
Secondary 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. Post 1 (Week 10) and Post 2 (Week 15) Intervention
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