NCT05801445

Brief Summary

The goal of this clinical trial is to compare two different types of activities in improving physical fitness in older adults. The main question it aims to answer is whether a person completing a large-scaled art project has similar physical improvements as a person completing a more traditional exercise program. Participants will be asked to either stand for up to an hour while completing a painting across a large canvas or stand for up to an hour while doing body weight exercises. Researchers will compare the painting group to the exercise group to see if physical improvements are the same or different.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

March 24, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

March 24, 2023

Last Update Submit

November 27, 2023

Conditions

Physical Fitness in Older Adults

Outcome Measures

Primary Outcomes (3)

  • Upper extremity active range of motion

    Degrees goniometry

    10 weeks

  • Upper and lower extremity strength

    Manual muscle test

    10 weeks

  • Standing balance

    Functional reach test

    10 weeks

Secondary Outcomes (1)

  • Self-motivation

    10 weeks

Study Arms (2)

Occupational Arm

EXPERIMENTAL
Behavioral: Occupation-based activity

Traditional Exercise Arm

ACTIVE COMPARATOR
Behavioral: Body-Weight Exercise

Interventions

Occupation-based activityBEHAVIORAL

Painting large-scale canvas

Occupational Arm
Body-Weight ExerciseBEHAVIORAL

Body-weight exercises designed for older adults

Traditional Exercise Arm

Eligibility Criteria

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

You may not qualify if:

  • Individuals unable to stand with minimal support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crowne Health Services

Citronelle, Alabama, 36522, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 6, 2023

Study Start

September 1, 2023

Primary Completion

November 17, 2023

Study Completion

November 27, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)