Older AdultsNCT04039438
Relationships Among Sedentary Behaviors and Other Factors
An observational study of Older Adults, run by East Carolina University at 1 site in United States.
Trial summary
Due to the increasing sedentary behaviors in older adults, it is important to understand the factors related to sedentary behaviors. Although systematic reviews have identified sociodemographic and environmental factors related sedentary behaviors, no study on the relationships between interested and important… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 9 Mar 2020
- Phase
- Observational
- 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
Study population: Medically stable older adults
Who may be able to join
- age of 65 years or older
- intact cognition confirmed by the Montreal Cognitive Assessment Blind score 18 or greater
- self-report of no physical activity restrictions from the physician
- sedentary lifestyle confirmed by the Rapid Assessment Disuse Index score 26 or greater,
- living 30 miles from the College of Allied Health Sciences at East Carolina University
Who cannot join
- An acute or terminal illness
- a myocardial infarction in the past 6 months
- unstable cardiovascular or metabolic disease
- neuromusculoskeletal disorders severely disrupting voluntary movement
- limb amputation
- upper or lower extremity fracture in the past 3 months
- current symptomatic hernias or hemorrhoids
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 57834
About this study
Official title: Relationships Among Interest and Importance of Activities, Sedentary Behaviors, and Socio-demographic Factors in Sedentary Older Adults in the Community
Due to the increasing sedentary behaviors in older adults, it is important to understand the factors related to sedentary behaviors. Although systematic reviews have identified sociodemographic and environmental factors related sedentary behaviors, no study on the relationships between interested and important activities and sedentary behaviors in older adults was found.
In this study, investigators aim to investigate the relationships among interested and important activities, sedentary behaviors, and sociodemographic factors in older adults living in the community. Investigators will recruit 30 sedentary older adults living in the community who are cognitively intact, have no physical limitations, and are medically stable. Participants will be assessed once using subjective and objective measures:
Read more
- estimated energy expenditure levels for interested, important, and current activities, 2) time spent on sedentary activities, and 3) sociodemographic factors.
The results of this study will provide supporting evidence for the role of meaningful occupations to decrease sedentary behaviors. In addition, the results may show the relevant sociodemographic factors that occupational therapy practitioners need to be aware when encouraging active lifestyle for sedentary older adults in the community.
- Conditions
- Older Adults
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be provided during the study nor participants will be receiving any intervention anywhere else.
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Card Sort
The Activity Card Sort assesses the participation level in instrumental, leisure, and social activities. The Activity Card Sort uses 89 photographs. For each photograph, participants will be asked if they are interested in doing the activity in each photograph, if the activity in each photograph is important for them to do, and if participants are currently doing it. Then, Three mean metabolic equivalent levels of interested, important, and current activities will be calculated.
Measured: One time during the initial, one-time study visit about their current stauts (participants are visited only once in the study)
Physical activity level
Physical activity level measured by ActiGraph GT9X Link. The data will be collected for at least 7-full days to record the pattern of activity levels of a week.
Measured: 10-14 consecutive days, 24/hours a day, following the initial, one-time visit (participants are visited only once in the study)
Sociodemographic form
The information will be used to determine the characteristics of the participants and generalizability of the results, and to determine the relationships with interested, important, and current activities. The form collects socio-demographic information, such as race, gender, highest education received, living status, occupations, total household annual income, recent hospitalization, cardiovascular risk factors, the number of medications taken daily, and weekly exercise level. Information is all self-reported.
Measured: One time during the initial, one-time study visit about their current status (participants are visited only once in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Aug 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Kim, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039438
- Sponsor's protocol ID
- UMCIRB 19-001417
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2019
- Last updated
- 4 Feb 2021
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among Interest and Importance of Activities, Sedentary Behaviors, and Socio-demographic Factors in Sedentary Older Adults in the Community
- ClinicalTrials.gov ID
- NCT04039438
- Acronym / sponsor ID
- UMCIRB 19-001417
- Conditions
- Older Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 31 Jul 2019 (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.
Due to the increasing sedentary behaviors in older adults, it is important to understand the factors related to sedentary behaviors. Although systematic reviews have identified sociodemographic and environmental factors related sedentary behaviors, no study on the relationships between interested and important activities and sedentary behaviors in older adults was found.
In this study, investigators aim to investigate the relationships among interested and important activities, sedentary behaviors, and sociodemographic factors in older adults living in the community. Investigators will recruit 30 sedentary older adults living in the community who are cognitively intact, have no physical limitations, and are medically stable. Participants will be assessed once using subjective and objective measures:
- estimated energy expenditure levels for interested, important, and current activities, 2) time spent on sedentary activities, and 3) sociodemographic factors.
The results of this study will provide supporting evidence for the role of meaningful occupations to decrease sedentary behaviors. In addition, the results may show the relevant sociodemographic factors that occupational therapy practitioners need to be aware when encouraging active lifestyle for sedentary older adults in the community.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Medically stable older adults
Key inclusion criteria (5 listed)
- age of 65 years or older
- intact cognition confirmed by the Montreal Cognitive Assessment Blind score 18 or greater
- self-report of no physical activity restrictions from the physician
- sedentary lifestyle confirmed by the Rapid Assessment Disuse Index score 26 or greater,
- living 30 miles from the College of Allied Health Sciences at East Carolina University
Key exclusion criteria (8 listed)
- An acute or terminal illness
- a myocardial infarction in the past 6 months
- unstable cardiovascular or metabolic disease
- neuromusculoskeletal disorders severely disrupting voluntary movement
- limb amputation
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 |
|---|---|---|
| No interventionNo intervention will be provided during the study nor participants will be receiving any intervention anywhere else. | Other | – |
Primary outcome
Activity Card Sort
Time frame: One time during the initial, one-time study visit about their current stauts (participants are visited only once in the study)
The Activity Card Sort assesses the participation level in instrumental, leisure, and social activities. The Activity Card Sort uses 89 photographs. For each photograph, participants will be asked if they are interested in doing the activity in each photograph, if the activity in each photograph is important for them to do, and if participants are currently doing it. Then, Three mean metabolic equivalent levels of interested, important, and current activities will be calculated.
Physical activity level
Time frame: 10-14 consecutive days, 24/hours a day, following the initial, one-time visit (participants are visited only once in the study)
Physical activity level measured by ActiGraph GT9X Link. The data will be collected for at least 7-full days to record the pattern of activity levels of a week.
Sociodemographic form
Time frame: One time during the initial, one-time study visit about their current status (participants are visited only once in the study)
The information will be used to determine the characteristics of the participants and generalizability of the results, and to determine the relationships with interested, important, and current activities. The form collects socio-demographic information, such as race, gender, highest education received, living status, occupations, total household annual income, recent hospitalization, cardiovascular risk factors, the number of medications taken daily, and weekly exercise level. Information is all self-reported.
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 Feb 2021.
- 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?
An observational study of Older Adults, run by East Carolina 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 5 inclusion and 8 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 Feb 2021. 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?
Activity Card Sort (time frame: One time during the initial, one-time study visit about their current stauts (participants are visited only once in the study)). 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 4 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.