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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05081505
Other study ID # KMUHIRB-E(II)-20190397
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2020
Est. completion date March 29, 2021

Study information

Verified date October 2021
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 29, 2021
Est. primary completion date March 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 82 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Structural exercise course
12-week structured exercise class, team competition, social support, and incentive strategy
Autonomous group class
12-week autonomous group class, team competition, social support, and incentive strategy

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Attendance rate The attendance rate of the subjects participating in structured exercise courses and autonomous group classes 12 and 24 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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