Physical Fitness Performance of Students With Physical and Mental DisabilitiesNCT04225377
Physical Therapy Combined With Adapted Education on Physical Fitness in College Students With Physical Disabilities
An observational study of Physical Fitness Performance of Students With Physical and Mental Disabilities and Physical Therapy Technology Integrated Into Physical Education Curriculum, run by China Medical University Hospital at 2 sites in Taiwan.
Trial summary
Purpose: To integrate therapeutic exercise and techniques of physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body, and health-related physical fitness training and physical therapy into adapted physical education courses to improve the limitations and… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Physical Fitness Performance of Students With Physical and Mental Disabilities, Physical Therapy Technology Integrated Into Physical Education Curriculum
- How many people
- 10 participants
- Where
- 2 sitesTaiwan
- Study dates
- 12 Dec 2019to 31 Jul 2020
- Phase
- Observational
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: 10 students of China Medical University will be recruited to take physical education courses (ages 18-25 years old), regardless of gender. Students who participate in the physical education courses are required to attach relevant certificates issued by the physician and sign the exercise safety consent form.
Who may be able to join
- College students whose body, mind and limbs are not suitable for strenuous exercise recognized by the Physical Education Office of China Medical University.
- College students with permanent or temporary physical and mental disabilities.
- College students with congenital disorders or temporary disorders.
Who cannot join
- Exercise will affect wound healing after surgery
- Medical order emphasize people who cannot exercise
- Certifiable disease
- Unable to follow the exercise command
- History of malignant tumors
- Any other factors that are unable to complete the exercise required in the course
- Subjects need to take matters in the Sports Safety Questionnaire project as a precaution
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Department of Physical Therapy of China Medical University
Taichung, Test2, test3
China Medical University
Taichung
About this study
Official title: Observational Study of Physical Therapy Combined With Adapted Education on Physical Fitness in College Students With Physical Disabilities
Purpose: To integrate therapeutic exercise and techniques of physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body, and health-related physical fitness training and physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body and to improve the physical fitness performance of the students with physical and mental disabilities. Expected results: Adapting to physical education curriculum supplemented by physical therapy techniques can effectively improve the degree of physical and mental impairment, the effect of add-on fitness training, and make the physical fitness performance of students with physical and mental disabilities more progressive.
Read the detailed description
Background: The degree of disorder of college students with physical and mental disabilities over 18 years old is mostly chronic, and the disease may be stable, the body and mind are more adaptable to their own disability, but also due to physical disorders, health-related physical fitness can enter the process of degradation earlier than the average person. Students with physical and mental disabilities can increase physical activity by adapted physical education courses, but because of their individual differences, the degree of disorder and the category are different. It is difficult to progress physical fitness without further professional intervention. Therefore, if the physiotherapy exercise therapy training and the hand-on treatment course are combined and integrated into the adapted physical education course and after-school time, it will be able to effectively improve the physical fitness performance of students with physical and mental disabilities. Purpose: To integrate therapeutic exercise and techniques of physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body, and health-related physical fitness training and physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body and to improve the physical fitness performance of the students with physical and mental disabilities. Methods: It is expected that 20-30 students and students over 18 years old who are involved in physical education classes will be recruited. One semester of physical education for a total of 18 weeks, 2 lessons per week (100 minutes), each class covers 40 minutes of individualized physical therapy sports therapy guidance and hand-on treatment and 40 minutes of group fitness training courses. The physical fitness assessment was conducted before the first week of each semester and after the 18th week. The "Physical Therapy and Adaptation to Physical Education" program was implemented for two semesters. The fitness assessment program mainly includes: cardio endurance, muscle fitness, body composition, softness and balance. Expected results: Adapting to physical education curriculum supplemented by physical therapy techniques can effectively improve the degree of physical and mental impairment, the effect of add-on fitness training, and make the physical fitness performance of students with physical and mental disabilities more progressive.
- Conditions
- Physical Fitness Performance of Students With Physical and Mental Disabilities, Physical Therapy Technology Integrated Into Physical Education Curriculum
- Keywords
- adapted physical education,Physical Therapy,physical fitness,disability
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture assessment
Using the plumb line to assess the subject's standing upright, whether the earlobe (mastoid process), acromion, middle torso, greater trochanter of femur, knee joint and lateral malleolus are on a vertical gravity line,whether the gravity line passes through the cervical, thoracic, lumbar and sacral vertebral concave posture assessment.
Measured: 36weeks
Secondary outcomes (6)
Body composition
Body mass index(BMI)== kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared
Measured: 36 weeks
Muscle fitness/muscle endurance
The subject sits on a chair with the soles of both feet resting on the ground, holding dumbbells (8 pounds for men, 5 pounds for women) with arms straight and hanging down next to the chair. After the start, the subject will bend his arms to the shoulders and calculate 30 seconds. The total number of correct bends in a second.
The subject sits in the middle of the chair with his back straight, hands crossed in front of his chest, after the start, the subject stands up and sits down, and counts the number of standing up and sitting times completed within 60 seconds.
Measured: 36 weeks
Upper and lower limbs and body flexibility
The subject adopts a standing posture, with the dominant hand placed behind the shoulder on the same side, with the palm facing the back, with the fingers straight, stretch down as far as possible along the center of the back, and the palm of the other hand outwards from the bottom Extend your back upwards, keep your hands as close as possible, touch each other, or overlap your hands. Never hold and pull with your hands. Measure the distance between the middle finger of both hands.
The subject sits on the front edge of the chair, with one foot bent on the ground, the other foot is straight forward, the heel touches the ground, the toes are raised, and the palms of both hands are folded (middle fingers) and stretched out. Stretch straight feet. Measure the distance from the middle finger to the toe.
The subject is standing with both feet, the body bends forward, left and right, and then measures the distance from the middle finger to the ground.
Measured: 36 weeks
Cardiopulmonary endurance
First measure the height of 1/2 of the line between the midpoint of the patella and the iliofemoral ridge of the subject, and mark it with colored tape on the wall or door frame as the basis for knee elevation. After the start, the subject should step on the spot as soon as possible, and the knee must be raised to the marked height. Record the number of steps completed in 2 minutes.
Measured: 36 weeks
Agility
The chair needs to lean against the wall or rely on other safety objects. The subject sits on the chair, with both feet on the ground, one foot can be slightly forward, and the chair can be supported when getting up, but running is not allowed during the journey. The subject sits on a chair. After the start, the subject stands up and walks to the pyramid, walks around the pyramid and returns to the chair to sit down and calculate the required time.
Measured: 36 weeks
Balance
Stand with your hands on your waist, stand on one foot, and place the foot off the ground on the inside of the ankle that supports your foot. Record the right and left foot support time for correct actions, with a full score of 30 seconds.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Dec 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Fitness Performance of Students With Physical and Mental DisabilitiesStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yueh Ling Hsieh's laboratory funding
- Responsible party
- Sponsor
- Investigators
- Yueh-Ling Hsieh, PHD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225377
- Sponsor's protocol ID
- CRREC-108-134
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Physical Therapy Combined With Adapted Education on Physical Fitness in College Students With Physical Disabilities
- ClinicalTrials.gov ID
- NCT04225377
- Acronym / sponsor ID
- CRREC-108-134
- Conditions
- Physical Fitness Performance of Students With Physical and Mental Disabilities, Physical Therapy Technology Integrated Into Physical Education Curriculum
- Keywords
- adapted physical education,Physical Therapy,physical fitness,disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Yueh Ling Hsieh's laboratory funding
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To integrate therapeutic exercise and techniques of physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body, and health-related physical fitness training and physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body and to improve the physical fitness performance of the students with physical and mental disabilities. Expected results: Adapting to physical education curriculum supplemented by physical therapy techniques can effectively improve the degree of physical and mental impairment, the effect of add-on fitness training, and make the physical fitness performance of students with physical and mental disabilities more progressive.
Detailed description
Background: The degree of disorder of college students with physical and mental disabilities over 18 years old is mostly chronic, and the disease may be stable, the body and mind are more adaptable to their own disability, but also due to physical disorders, health-related physical fitness can enter the process of degradation earlier than the average person. Students with physical and mental disabilities can increase physical activity by adapted physical education courses, but because of their individual differences, the degree of disorder and the category are different. It is difficult to progress physical fitness without further professional intervention. Therefore, if the physiotherapy exercise therapy training and the hand-on treatment course are combined and integrated into the adapted physical education course and after-school time, it will be able to effectively improve the physical fitness performance of students with physical and mental disabilities. Purpose: To integrate therapeutic exercise and techniques of physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body, and health-related physical fitness training and physical therapy into adapted physical education courses to improve the limitations and obstacles of the physical body and to improve the physical fitness performance of the students with physical and mental disabilities. Methods: It is expected that 20-30 students and students over 18 years old who are involved in physical education classes will be recruited. One semester of physical education for a total of 18 weeks, 2 lessons per week (100 minutes), each class covers 40 minutes of individualized physical therapy sports therapy guidance and hand-on treatment and 40 minutes of group fitness training courses. The physical fitness assessment was conducted before the first week of each semester and after the 18th week. The "Physical Therapy and Adaptation to Physical Education" program was implemented for two semesters. The fitness assessment program mainly includes: cardio endurance, muscle fitness, body composition, softness and balance. Expected results: Adapting to physical education curriculum supplemented by physical therapy techniques can effectively improve the degree of physical and mental impairment, the effect of add-on fitness training, and make the physical fitness performance of students with physical and mental disabilities more progressive.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 10 students of China Medical University will be recruited to take physical education courses (ages 18-25 years old), regardless of gender. Students who participate in the physical education courses are required to attach relevant certificates issued by the physician and sign the exercise safety consent form.
Key inclusion criteria (3 listed)
- College students whose body, mind and limbs are not suitable for strenuous exercise recognized by the Physical Education Office of China Medical University.
- College students with permanent or temporary physical and mental disabilities.
- College students with congenital disorders or temporary disorders.
Key exclusion criteria (7 listed)
- Exercise will affect wound healing after surgery
- Medical order emphasize people who cannot exercise
- Certifiable disease
- Unable to follow the exercise command
- History of malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posture assessment
Time frame: 36weeks
Using the plumb line to assess the subject's standing upright, whether the earlobe (mastoid process), acromion, middle torso, greater trochanter of femur, knee joint and lateral malleolus are on a vertical gravity line,whether the gravity line passes through the cervical, thoracic, lumbar and sacral vertebral concave posture assessment.
6 secondary outcomes
Body composition
Time frame: 36 weeks
Muscle fitness/muscle endurance
Time frame: 36 weeks
Upper and lower limbs and body flexibility
Time frame: 36 weeks
Cardiopulmonary endurance
Time frame: 36 weeks
Agility
Time frame: 36 weeks
Balance
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueh-Ling Hsieh, PHD principal investigator
China Medical University, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Fitness Performance of Students With Physical and Mental Disabilities and Physical Therapy Technology Integrated Into Physical Education Curriculum, run by China Medical University Hospital at 2 sites 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 3 inclusion and 7 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Posture assessment (time frame: 36weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.