NCT04957381

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

April 26, 2021

Last Update Submit

July 9, 2021

Conditions

Keywords

Healthy agingCardiorespiratory fitnessMuscular fitnessHealth promotion

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    once follow up at 2-4 years after community-based health promotion programs

Study Arms (5)

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

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

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

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

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

Interventions

Group exercisesBEHAVIORAL

Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.

high CRF and high MFhigh CRF with low to moderate MFlow to moderate CRF with high MFlow to moderate CRF with low MFlow to moderate CRF with moderate MF

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling older adults

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsai, Mei-Wun

Taipei, 112, Taiwan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 26, 2021

First Posted

July 12, 2021

Study Start

November 12, 2020

Primary Completion

November 11, 2021

Study Completion

December 31, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Locations