Physical Fitness in Older AdultsNCT05801445
Increasing Movement and Exercise in Geriatric Patients Through Large-Scaled Creative Occupation Interventions
A study testing Occupation-based activity and Body-Weight Exercise in people with Physical Fitness in Older Adults, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness in Older Adults
- What is being tested?
- Occupation-based activity and Body-Weight Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 27 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals unable to stand with minimal support
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The purpose of this study is to determine whether large-scaled creative occupations, such as painting large paintings, would be equally, if not more beneficial than traditional exercise for older adults. Painting on large mural-sized paintings will simulate the participation of endurance heavy, physically demanding tasks. This is because to complete the task, participants will be required to reach to cover the canvas, stand for extended periods of time, and perform repetitive movements. It is hypothesized that this activity will increase active range of motion, strength, endurance, balance, as well as motivation to participate in physical activity by providing a more enjoyable, alternative form of exercise.
- Conditions
- Physical Fitness in Older Adults
- Being tested
- Occupation-based activity, Body-Weight Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-based activityBehavioural
Painting large-scale canvas
Body-Weight ExerciseBehavioural
Body-weight exercises designed for older adults
| Study group | Role | What they receive |
|---|---|---|
| Occupational Arm | Experimental | Not described Receives: Behavioral: Occupation-based activity |
| Traditional Exercise Arm | Active comparator | Not described Receives: Behavioral: Body-Weight Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity active range of motion
Degrees goniometry
Measured: 10 weeks
Upper and lower extremity strength
Manual muscle test
Measured: 10 weeks
Standing balance
Functional reach test
Measured: 10 weeks
Secondary outcomes (1)
Self-motivation
Questionnaire
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Sep 2023
- Primary completion17 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Fitness in Older AdultsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Eugene Vice, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801445
- Sponsor's protocol ID
- IRB-300010109
- Status last verified
- Nov 2023
- First submitted
- 24 Mar 2023
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Movement and Exercise in Geriatric Patients Through Large-Scaled Creative Occupation Interventions
- ClinicalTrials.gov ID
- NCT05801445
- Acronym / sponsor ID
- IRB-300010109
- Conditions
- Physical Fitness in Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 6 Apr 2023 (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 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.
Detailed description
The purpose of this study is to determine whether large-scaled creative occupations, such as painting large paintings, would be equally, if not more beneficial than traditional exercise for older adults. Painting on large mural-sized paintings will simulate the participation of endurance heavy, physically demanding tasks. This is because to complete the task, participants will be required to reach to cover the canvas, stand for extended periods of time, and perform repetitive movements. It is hypothesized that this activity will increase active range of motion, strength, endurance, balance, as well as motivation to participate in physical activity by providing a more enjoyable, alternative form of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Arm | Experimental | Behavioral: Occupation-based activity |
| Traditional Exercise Arm | Active comparator | Behavioral: Body-Weight Exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals unable to stand with minimal support
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 |
|---|---|---|
| Occupation-based activityPainting large-scale canvas | Behavioural | Occupational Arm |
| Body-Weight ExerciseBody-weight exercises designed for older adults | Behavioural | Traditional Exercise Arm |
Primary outcome
Upper extremity active range of motion
Time frame: 10 weeks
Degrees goniometry
Upper and lower extremity strength
Time frame: 10 weeks
Manual muscle test
Standing balance
Time frame: 10 weeks
Functional reach test
1 secondary outcome
Self-motivation
Time frame: 10 weeks
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 28 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-based activity and Body-Weight Exercise in people with Physical Fitness in Older Adults, run by University of Alabama at Birmingham 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 0 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 28 Nov 2023. 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?
Upper extremity active range of motion (time frame: 10 weeks). The study lists 3 primary outcomes in all. 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 28 Nov 2023.