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

October 5, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
Interventional

Enrollment (Actual)

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.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Kaohsiung, Taiwan, 80708
        • Kaohsiung Medical University

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

65 years to 82 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Community-based physical fitness exercise course
Included 12-week structural exercise course (0-12 weeks) and 12-week autonomous group class (12-24 weeks).
Behavioral: Structural exercise course
12-week structured exercise class, team competition, social support, and incentive strategy
Behavioral: Autonomous group class
12-week autonomous group class, team competition, social support, and incentive strategy

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
Exercise stage of change questionnaire
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Physical Activity Scale for the Elderly (PASE)
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Exercise Self-efficacy Scale
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Outcome Expectations for Exercise Scale
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Physical Activity Survey
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Attendance rate
Time Frame: 12 and 24 weeks
The attendance rate of the subjects participating in structured exercise courses and autonomous group classes
12 and 24 weeks
Senior Fitness Test - Body Mass Index (BMI)
Time Frame: basal, 12, 24 weeks follow up
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
basal, 12, 24 weeks follow up
Senior Fitness Test - Waist-hip ratio
Time Frame: basal, 12, 24 weeks follow up
The waist-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips.
basal, 12, 24 weeks follow up
Senior Fitness Test - 30s Chair stand
Time Frame: basal, 12, 24 weeks follow up
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
basal, 12, 24 weeks follow up
Senior Fitness Test - Chair Sit-&-Reach
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Senior Fitness Test - 8-Foot Up-&-Go
Time Frame: basal, 12, 24 weeks follow up
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.
basal, 12, 24 weeks follow up
Senior Fitness Test - 30s Arm curl
Time Frame: basal, 12, 24 weeks follow up
Evaluates the upper body strength and endurance according to the number of arm curls in 30 seconds. Characterized as continuous numeric variable.
basal, 12, 24 weeks follow up
Senior Fitness Test - Back scratch
Time Frame: basal, 12, 24 weeks follow up
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
basal, 12, 24 weeks follow up
Senior Fitness Test - 2-Minute Step
Time Frame: basal, 12, 24 weeks follow up
Evaluates aerobic endurance. Total double past stationary in 2 minutes. Characterized as continuous numeric variable.
basal, 12, 24 weeks follow up
Open-eyes one leg stand
Time Frame: basal, 12, 24 weeks follow up
Evaluates the balance ability. The standing time on one leg, keep eyes open. Characterized as continuous numeric variable.
basal, 12, 24 weeks follow up

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.
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.
March 30, 2020

Primary Completion (Actual)

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.
March 29, 2021

Study Completion (Actual)

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.
March 29, 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).
October 5, 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.
October 5, 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.
October 18, 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.
October 18, 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.
October 5, 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.
October 1, 2021

More Information

Terms related to this study

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.
  • KMUHIRB-E(II)-20190397

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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