- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957381
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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
-
-
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Taipei, Taiwan, 112
- Tsai, Mei-Wun
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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
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 |
Intervention / Treatment |
---|---|
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).
|
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).
|
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).
|
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).
|
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).
|
Group exercises including aerobic, resistance and stretching exercise.
Once a week for 8-12 weeks.
|
What is the study measuring?
Primary Outcome Measures
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.
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once follow up at 2-4 years after community-based health promotion programs
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Physiological health: independence in basic activities of daily living
Time Frame: once follow up at 2-4 years after community-based health promotion programs
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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
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Physiological health: independence in instrumental activities of daily living
Time Frame: once follow up at 2-4 years after community-based health promotion programs
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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.
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once follow up at 2-4 years after community-based health promotion programs
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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.
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once follow up at 2-4 years after community-based health promotion programs
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Mental health: absent of depression status
Time Frame: once follow up at 2-4 years after community-based health promotion programs
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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.
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once follow up at 2-4 years after community-based health promotion programs
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Social function: good social relations
Time Frame: once follow up at 2-4 years after community-based health promotion programs
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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.
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once follow up at 2-4 years after community-based health promotion programs
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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
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)
November 12, 2020
Primary Completion (Anticipated)
November 11, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
July 9, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID 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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