NCT05081505

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

March 30, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

October 5, 2021

Last Update Submit

October 5, 2021

Conditions

Outcome Measures

Primary Outcomes (15)

  • 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.

    basal, 12, 24 weeks follow up

  • 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.

    basal, 12, 24 weeks follow up

  • 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.

    basal, 12, 24 weeks follow up

  • 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.

    basal, 12, 24 weeks follow up

  • 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.

    basal, 12, 24 weeks follow up

  • Attendance rate

    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)

    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

    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

    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

    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

    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

    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

    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

    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

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

    basal, 12, 24 weeks follow up

Study Arms (1)

Community-based physical fitness exercise course

EXPERIMENTAL

Included 12-week structural exercise course (0-12 weeks) and 12-week autonomous group class (12-24 weeks).

Behavioral: Structural exercise courseBehavioral: Autonomous group class

Interventions

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

Community-based physical fitness exercise course

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

Community-based physical fitness exercise course

Eligibility Criteria

Age65 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 18, 2021

Study Start

March 30, 2020

Primary Completion

March 29, 2021

Study Completion

March 29, 2021

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations