NCT04281654

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2020

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

July 29, 2019

Last Update Submit

February 16, 2022

Conditions

Social IsolationMental Status ChangeCognitive ImpairmentPhysical ActivityQuality of LifeSelf-Perception

Keywords

DanceMusicSocial Conversation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Cognition using Montreal Cognitive Assessment (MOCA) survey

    Pre (Week 0), Post 1 (Week 10) and Post 2 (Week 15) Intervention

  • Change in Self-Perception Post Intervention Focus Interview

    Post 1 (Week 10) and Post 2 (Week 15) Intervention

  • Change in Social Connections using the Social Connections Survey

    Post 1 (Week 10) and Post 2 (Week 15) Intervention

Study Arms (3)

Ballroom Dance

EXPERIMENTAL

The Dance group participants will take part in ballroom dance lessons twice/week for 45-minutes/session for 10 weeks

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

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

Other: Active Social Conversation

Interventions

Active Social ConversationOTHER

Active Social Conversation

Also known as: Active Control
Ballroom DanceControlUkulele

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be healthy,
  • \> 65 years of age and able to take part in learning music, or ballroom dance.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hylton Performing Arts Center

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Social IsolationCognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jatin P Ambegaonkar, PhD

    George Mason University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

February 24, 2020

Study Start

September 1, 2019

Primary Completion

April 25, 2020

Study Completion

April 26, 2020

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)