Healthy AgingNCT04957381
The Effect of Cardiopulmonary and Muscular Fitness on Healthy Aging Among Community-Dwelling Older Adults
An observational study of Healthy Aging, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Group exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Nov 2020to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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 55 to 100 years
- All sexes
- Adult, Older adult
Study population: Community-dwelling older adults
Who may be able to join
- Aged ≥ 55 years old
- Had contact information from project
- Had attended both pre-test or post-test during program
- Volunteer to participant
Who cannot join
- Incomplete physical fitness data
- Participant with frailty after screening during the class
- Not available to respond
- Not accept the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- Group exercises
- Keywords
- Healthy aging, Cardiorespiratory fitness, Muscular fitness, Health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exercisesBehavioural
Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Group exercises | |
| 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). Receives: Behavioral: Group exercises | |
| 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). Receives: Behavioral: Group exercises | |
| 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). Receives: Behavioral: Group exercises | |
| 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). Receives: Behavioral: Group exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological health: non-frailty
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Physiological health: independence in basic activities of daily living
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Physiological health: independence in instrumental activities of daily living
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Mental health: normal cognitive function
MoCA (Montreal cognitive assessment). Minimum value is 0 and maximum value is 30. Normal cognitive function is defined as score above 24.
Measured: once follow up at 2-4 years after community-based health promotion programs
Mental health: absent of depression status
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Social function: good social relations
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Social function: good environmental support
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.
Measured: once follow up at 2-4 years after community-based health promotion programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start12 Nov 2020
- Primary completion11 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wun Tsai, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957381
- Sponsor's protocol ID
- YM109154E
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiopulmonary and Muscular Fitness on Healthy Aging Among Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04957381
- Acronym / sponsor ID
- YM109154E
- Conditions
- Healthy Aging
- Keywords
- Healthy aging, Cardiorespiratory fitness, Muscular fitness, Health promotion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 11 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Jul 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| low to moderate CRF with low MF | – | Behavioral: Group exercisesAccording to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and low muscular fitness (MF). |
| low to moderate CRF with moderate MF | – | Behavioral: Group exercisesAccording to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and moderate muscular fitness (MF). |
| low to moderate CRF with high MF | – | Behavioral: Group exercisesAccording to the senior fitness test norms in Taiwan, participants with low to moderate cardiorespiratory fitness (CRF) and high muscular fitness (MF). |
| high CRF with low to moderate MF | – | Behavioral: Group exercisesAccording to the senior fitness test norms in Taiwan, participants with high cardiorespiratory fitness (CRF) and low to moderate muscular fitness (MF). |
| high CRF and high MF | – | Behavioral: Group exercisesAccording to the senior fitness test norms in Taiwan, participants with high cardiorespiratory fitness (CRF) and high muscular fitness (MF). |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older adults
Key inclusion criteria (4 listed)
- Aged ≥ 55 years old
- Had contact information from project
- Had attended both pre-test or post-test during program
- Volunteer to participant
Key exclusion criteria (4 listed)
- Incomplete physical fitness data
- Participant with frailty after screening during the class
- Not available to respond
- Not accept the informed consent
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 |
|---|---|---|
| Group exercisesGroup exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks. | Behavioural | high CRF and high MF, high CRF with low to moderate MF, low to moderate CRF with high MF, low to moderate CRF with low MF, low to moderate CRF with moderate MF |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 Healthy Aging, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 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 Taiwan. 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?
Results are not available in the source record.
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?
Physiological health: non-frailty (time frame: once follow up at 2-4 years after community-based health promotion programs). The study lists 7 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 12 Jul 2021.