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Older AdultNCT05081505

Community-based Physical Fitness Exercise on the Older Adults' Functional Fitness and Adherence to Physical Activity

A study testing Structural exercise course and Autonomous group class in people with Older Adult, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Maintaining adequate physical activity (PA) and regularly exercising are very important to promote the good physical and mental health of the elderly. According to the transtheoretical model (TTM) framework, previous research studies have formulated many strategies to promote exercise behaviors, such as incentive… Read more about this study

Who is it for?
Ages 65 to 82 yearsHealthy volunteers can take part
Conditions the study is for
Older Adult
What is being tested?
Structural exercise course and Autonomous group class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
30 Mar 2020to 29 Mar 2021
Phase
Interventional
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 65 to 82 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • age between 65 to 90 years old
  • can stand up from a chair without armrests
  • can walk independently for 2 minutes without relying on any mechanical assistance
  • no medical issues according to the PAR-Q+ form assessment
  • can complete the Senior Fitness Test (SFT)

Who cannot join

  • diagnosed with severe dementia (unable to understand and/or follow verbal commands)
  • suffering from stroke, severe hypertension, heart disease, and diabetes
  • hip or knee replacement surgery in the past 6 months
  • hip fracture
  • having undergoing rehabilitation plan
  • unable to complete the pre-tests or post-test

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University

    Kaohsiung City, 80708

Other trials in Taiwan

About this study

Official title: The Influence of a New Intervention Model of Community-based Physical Fitness Exercise on the Older Adults' Adherence to Physical Activity and the Improvement of Functional Fitness

Maintaining adequate physical activity (PA) and regularly exercising are very important to promote the good physical and mental health of the elderly. According to the transtheoretical model (TTM) framework, previous research studies have formulated many strategies to promote exercise behaviors, such as incentive strategies, combines municipal resources and links up with the referral of primary care institutions, or including patients in the decision-making process about exercise choices to enable patients to have greater autonomy. In addition, in terms of the strategic aspects of achieving goals, competitive incentives are also an effective strategy. Therefore, this study aims to find out the effects of the community-based physical fitness exercise course, which is given according to TTM, on improving functional fitness and exercise persistence of the older adults.

Conditions
Older Adult
Being tested
Structural exercise course, Autonomous group class

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structural exercise courseBehavioural

    12-week structured exercise class, team competition, social support, and incentive strategy

  • Autonomous group classBehavioural

    12-week autonomous group class, team competition, social support, and incentive strategy

Study groups in NCT05081505
Study groupRoleWhat they receive
Community-based physical fitness exercise courseExperimentalIncluded 12-week structural exercise course (0-12 weeks) and 12-week autonomous group class (12-24 weeks).
Receives: Behavioral: Structural exercise course; Behavioral: Autonomous group class

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise stage of change questionnaire

    Exercise Change Stage Short Question Form is a 5 item scale. It has only one question, used to categorizes individuals into one of the five stages of change: (1) Precontemplation (2) Contemplation (3) Preparation (4) Action (5) Maintenance.

    Measured: basal, 12, 24 weeks follow up

  2. Physical Activity Scale for the Elderly (PASE)

    PASE is used to assess the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile. The minimum and maximum score that can be obtained from the scale is 0 and 400.The higher score indicates better level of physical activity.

    Measured: basal, 12, 24 weeks follow up

  3. Exercise Self-efficacy Scale

    The Exercise Self-efficacy Scale measures an individual's perceived ability to overcome various obstacles to perform physical activity, with higher scores indicating more confidence in performing the exercise.

    Measured: basal, 12, 24 weeks follow up

  4. Outcome Expectations for Exercise Scale

    The Outcome Expectations for Exercise Scale contains 9 statements rated by participants using a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree". It can help identify older adults with low outcome expectations for exercise.

    Measured: basal, 12, 24 weeks follow up

  5. Physical Activity Survey

    The physical activity survey is measured according to the PASE items. It is calculated by the frequency value (hours per day in the one-week reporting period) for low-intensity, medium-intensity, high-intensity, and muscle strengthening exercise. The higher score indicates the more time spent on the physical activity at each level.

    Measured: basal, 12, 24 weeks follow up

  6. Attendance rate

    The attendance rate of the subjects participating in structured exercise courses and autonomous group classes

    Measured: 12 and 24 weeks

  7. Senior Fitness Test - Body Mass Index (BMI)

    Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.

    Measured: basal, 12, 24 weeks follow up

  8. Senior Fitness Test - Waist-hip ratio

    The waist-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips.

    Measured: basal, 12, 24 weeks follow up

  9. Senior Fitness Test - 30s Chair stand

    Evaluates the lower body strength according to the number of times the individual stood up and sat down in 30 seconds. Characterized as continuous numeric variable

    Measured: basal, 12, 24 weeks follow up

  10. Senior Fitness Test - Chair Sit-&-Reach

    Evaluates the lower back and hamstring flexibility according to the distance measured between the tip of the finger tips and the toes. Characterized as continuous numerical variable.

    Measured: basal, 12, 24 weeks follow up

  11. Senior Fitness Test - 8-Foot Up-&-Go

    Assesses motor agility and dynamic balance. Evaluates the time in seconds and hundredths in an established path of 2.44 meters on the route to go and return to starting position. Characterized as continuous numerical variable.

    Measured: basal, 12, 24 weeks follow up

  12. Senior Fitness Test - 30s Arm curl

    Evaluates the upper body strength and endurance according to the number of arm curls in 30 seconds. Characterized as continuous numeric variable.

    Measured: basal, 12, 24 weeks follow up

  13. Senior Fitness Test - Back scratch

    Evaluates the flexibility of the upper limbs. It measures the distance in inches between the tips of the fingers in the back area. Characterized as continuous numeric variable

    Measured: basal, 12, 24 weeks follow up

  14. Senior Fitness Test - 2-Minute Step

    Evaluates aerobic endurance. Total double past stationary in 2 minutes. Characterized as continuous numeric variable.

    Measured: basal, 12, 24 weeks follow up

  15. Open-eyes one leg stand

    Evaluates the balance ability. The standing time on one leg, keep eyes open. Characterized as continuous numeric variable.

    Measured: basal, 12, 24 weeks follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start30 Mar 2020
  3. Primary completion29 Mar 2021
  4. Study completion29 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single group trial, according to the pre-test result of the exercise stage of the change questionnaire, they were divided into the maintenance phase group (MP, N=15) and under the maintenance phase group (MPb, N=15). All subjects joined the community-based physical fitness exercise course for 24 weeks. To quantify the effect of this intervention method on functional fitness and exercise persistence of the elderly, this study analyzed the related exercise behavior changes of MPb and MP elderly.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081505
Sponsor's protocol ID
KMUHIRB-E(II)-20190397
Status last verified
Oct 2021
First submitted
5 Oct 2021
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Structural exercise course and Autonomous group class in people with Older Adult, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 18 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Exercise stage of change questionnaire (time frame: basal, 12, 24 weeks follow up). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081505.

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 18 Oct 2021.

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