Relationships Among Sedentary Behaviors and Other Factors

February 2, 2021 updated by: Young Joo Kim, East Carolina University

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:

1) 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 57834
        • East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medically stable older adults

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One time during the initial, one-time study visit about their current stauts (participants are visited only once in the study)
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.
10-14 consecutive days, 24/hours a day, following the initial, one-time visit (participants are visited only once in the study)
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.
One time during the initial, one-time study visit about their current status (participants are visited only once in the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Carolina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMCIRB 19-001417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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