The Effect of Cardiopulmonary and Muscular Fitness on Healthy Aging Among Community-Dwelling Older Adults

July 9, 2021 updated by: Mei-Wun Tsai, National Yang Ming University
To compare the different cardiopulmonary and muscular fitness of community-dwelling older adults on healthy aging, and to identify the optimal cutoff points of their cardiopulmonary fitness and muscular fitness on targeting healthy aging.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

Detailed Description

At the end of the 20th century, the WHO began to promote the issue of healthy aging. From then on, the Taiwan government gradually attached importance to long-term care and devoted to developing community-based health promotion programs for the elderly. Currently, the programs commonly plan to proceed through the group exercise intervention, increasing physical activity to improve their physical fitness and also to prevent their functional disability. This study aims to compare the different cardiorespiratory fitness and muscular fitness of community-dwelling older adults on healthy aging, and figure out to what extent of cardiorespiratory fitness level and muscular fitness level may achieve healthy aging. The present healthy status of participants will be investigated by interviewing if having any disability or frail. Based on multidimensional model, the definition and measurement of healthy aging status include physiological, psychological and social function aspect. In this study, the health aging status is defined as non-frailty, independence in basic and instrumental activities of daily living, normal cognitive function, absent of depression status, good social relations and good environmental support.

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 (Anticipated)

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.
200

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

  • Taiwan
      • Taipei, Taiwan, 112
        • Tsai, Mei-Wun

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

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community-dwelling older adults

Description

Inclusion Criteria:

  • Aged ≥ 55 years old
  • Had contact information from project
  • Had attended both pre-test or post-test during program
  • Volunteer to participant

Exclusion Criteria:

  • Incomplete physical fitness data
  • Participant with frailty after screening during the class
  • Not available to respond
  • Not accept the informed consent

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
low to moderate CRF with low MF
According to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and low muscular fitness (MF).
Behavioral: Group exercises
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
low to moderate CRF with moderate MF
According to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and moderate muscular fitness (MF).
Behavioral: Group exercises
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
low to moderate CRF with high MF
According to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and high muscular fitness (MF).
Behavioral: Group exercises
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
high CRF with low to moderate MF
According to the senior fitness test norms in Taiwan, participants with high cardiorespiratory fitness (CRF) and low to moderate muscular fitness (MF).
Behavioral: Group exercises
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
high CRF and high MF
According to the senior fitness test norms in Taiwan, participants with high cardiorespiratory fitness (CRF) and high muscular fitness (MF).
Behavioral: Group exercises
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.

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
Physiological health: non-frailty
Time Frame: once follow up at 2-4 years after community-based health promotion programs
SOF index (study of osteoporotic fracture index). Minimum value is 0 and maximum value is 3. Non-frailty is defined as the score less than 2 points.
once follow up at 2-4 years after community-based health promotion programs
Physiological health: independence in basic activities of daily living
Time Frame: once follow up at 2-4 years after community-based health promotion programs
Katz ADL index (Katz index of independence in activities of daily living). Minimum value is 0 and maximum value is 6. Independence in basic ADL is defined as that score 0 point.
once follow up at 2-4 years after community-based health promotion programs
Physiological health: independence in instrumental activities of daily living
Time Frame: once follow up at 2-4 years after community-based health promotion programs
Lawton IADL scale (Lawton scale of instrumental activities of daily living). Minimum value is 0 and maximum value is 8. Independence in IADL is defined as that score 0 point.
once follow up at 2-4 years after community-based health promotion programs
Mental health: normal cognitive function
Time Frame: once follow up at 2-4 years after community-based health promotion programs
MoCA (Montreal cognitive assessment). Minimum value is 0 and maximum value is 30. Normal cognitive function is defined as score above 24.
once follow up at 2-4 years after community-based health promotion programs
Mental health: absent of depression status
Time Frame: once follow up at 2-4 years after community-based health promotion programs
GDS-15 (short form geriatric depression scale). Minimum value is 0 and maximum value is 15. Absent of depression status is defined as score less than 5.
once follow up at 2-4 years after community-based health promotion programs
Social function: good social relations
Time Frame: once follow up at 2-4 years after community-based health promotion programs
WHOQOL-BREF (WHO Quality of Life-BREF questionnaire). Minimum value is 4 and maximum value is 20. Good social relations is defined as score above 15.
once follow up at 2-4 years after community-based health promotion programs
Social function: good environmental support
Time Frame: once follow up at 2-4 years after community-based health promotion programs
WHOQOL-BREF (WHO Quality of Life-BREF questionnaire). Minimum value is 4 and maximum value is 20. Good environment support is defined as score above 15.
once follow up at 2-4 years after community-based health promotion programs

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.
National Yang Ming 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.
November 12, 2020

Primary Completion (Anticipated)

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.
November 11, 2021

Study Completion (Anticipated)

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.
December 31, 2021

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).
April 26, 2021

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 9, 2021

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 12, 2021

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.
July 12, 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.
July 9, 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.
July 1, 2021

More Information

Terms related to this study

Keywords

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.
  • YM109154E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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