- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081505
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
12-week structured exercise class, team competition, social support, and incentive strategy
12-week autonomous group class, team competition, social support, and incentive strategy
|
What is the study measuring?
Primary Outcome Measures
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.
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)
March 30, 2020
Primary Completion (Actual)
March 29, 2021
Study Completion (Actual)
March 29, 2021
Study Registration Dates
First Submitted
October 5, 2021
First Submitted That Met QC Criteria
October 5, 2021
First Posted (Actual)
October 18, 2021
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Older Adult
-
University of NottinghamRecruitingOlder AdultUnited Kingdom
-
University of Castilla-La ManchaCompleted
-
Brigham Young UniversityCompleted
-
University of ExtremaduraActive, not recruitingOlder Adults, Balance | Postural Balance | Older Adult | Balance AssessmentSpain
-
The Hong Kong Polytechnic UniversityCompleted
-
University of ManitobaCompletedOlder Adult Manual Wheelchair UsersCanada
-
Pamukkale UniversityCompletedDual Task | Community Dwelling Older AdultTurkey
-
Haukeland University HospitalNot yet recruitingGeneral Adult Population | Age 16 and Older
Clinical Trials on Structural exercise course
-
The Hong Kong Polytechnic UniversityRecruitingChronic Low Back Pain (CLBP)Hong Kong
-
Medical Research Council Cognition and Brain Sciences...University of CambridgeActive, not recruiting
-
VA Office of Research and DevelopmentCompleted
-
National Taiwan University HospitalNational Taiwan Normal UniversityCompletedElderly | Exercise TrainingTaiwan
-
Kaohsiung Medical University Chung-Ho Memorial...RecruitingSatisfaction | Working Memory | Balance | Lower Limb | Strength | ComplianceTaiwan
-
University of CyprusUniversity of Crete; VU University of Amsterdam; Eotvos Lorand UniversityRecruiting
-
University of MiamiCompletedQuality of Life | Hidradenitis SuppurativaUnited States
-
Kathmandu University School of Medical SciencesCompletedAntibiotic Prescription | Antibiotic | Fracture Tibia | Fracture Femur | Surgical Site Infection (SSI)Nepal
-
Ottawa Hospital Research InstituteCompletedCardiopulmonary Resuscitation | Basic Life Saving Skills | Skill RetentionCanada
-
International Atomic Energy AgencyCompletedEsophageal CancerChina, Canada, Croatia, India, Pakistan, South Africa, Thailand