Physical ActivityNCT03842215
A Smart Physical Examination System for the Health Management in Elderly
An observational study of Physical Activity, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The object of this study is to develop a smart physical examination system targeted on the unmet need of the elderly.Furthermore,the ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- smart physical exam
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jan 2019to Feb 2022
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling people who are recruited from the local community, hospital, club.
Who may be able to join
- 1.55-85 years old 2.people who can do movement by 3.people who can walk >10m independently.
Who cannot join
- people who implant cardiac rhythm, have cardiac arrhythmia,tumor,infection,or any other internal disease.
- people who have visual disturbance (Corrected vision<4.0 or any ophthalmic diseases caused bad eyesight),hearing loss,movement disorder.
- people who can't stand stably.
- people who can't fill out a questionnaire independently.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 500
Tasen Wei, 886-4-7238595 ext. 7416, tasen@cch.org.tw
Tasen Wei
About this study
Official title: Development and Clinical Applications of a Smart Physical Examination System for the Health Management in Elderly
The object of this study is to develop a smart physical examination system targeted on the unmet need of the elderly.Furthermore,the ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
Read the detailed description
Aging usually results in a decline of motor function. However, elderly tends to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instantly feedback the health status of elderly due to insufficient manpower. If elderly goes to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system targeted on the unmet need of the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. Following the principle of commercialization, this project aims at working out the product prototype, finalize the assessment tools/algorithm, and put it into the clinical trials. The project research team comprising the physicians, therapists, hardware and software systems engineering experts, with the early manufacturing involvement from the industry partner. The team members will work closely to solve the clinical, engineering, and market demand issues during the development process. The project will build a platform to deepen the bilateral understanding and research cooperation to solve the aging society problem. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
- Conditions
- Physical Activity
- Being tested
- smart physical exam
- Keywords
- smart physical examination system, health management, elderly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart physical examDevice
Use smart physical exam to collect functional performance
| Study group | Role | What they receive |
|---|---|---|
| silver hair people | Exam subject's physical function by a smart physical exam Receives: Device: smart physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Leg Balance Test
Remove the shoes and stand on the floor. Stand on one leg for 60 seconds and record the duration (seconds) that subject keeps one leg stand.
The test is stopped
- if the legs touch each other,
- if the weight-bearing foot moves on the floor,
- if the non-weight bearing foot touches the floor
- if the hands are removed from the waist.
Measured: Test once while subject is recruited.
Functional Reach Test
Position the patient close to the wall. The patient is instructed to stand with feet shoulder distance apart then make a fist and raise the arm up so that it's parallel to the floor.
At this time, the practitioner takes an initial reading on the yardstick, usually spotting the knuckle of the third metacarpal.
The patient is instructed to reach forward along the yardstick without moving the feet, the hand should remain in a fist.
The practitioner takes a reading on the yardstick of the farthest reach (cm) attained by the patient without taking a step.
Measured: Test once while subject is recruited.
Chair Sit and Reach Test
The subject sits on the edge of a chair. One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Place one hand on top of the other with tips of the middle fingers even. Instruct the subject to Inhale, and then as they exhale, reach forward toward the toes by bending at the hip. Keep the back straight and head up.
Keep the knee straight, and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch the toes then the score is zero. If they do not touch, measure the distance between the fingers and the toes (a negative score), if they overlap, measured by how much (a positive score). Perform two trials.
The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Record which leg was used for measurement.
Measured: Test once while subject is recruited.
2 minute step
The subject stands up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the patella (knee cap) and iliac crest (top of the hip bone). The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Resting is allowed, and holding onto the wall or a stable chair is allowed. Stop after two minutes of stepping, and measure the heart rate (beats/min).
Measured: Test once while subject is recruited.
Arm Curl Test
The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side. The subject sits on the chair, holding the weight in the hand using a suitcase grip with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving. Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds.
The repetitions of arm curl are recorded.
Measured: Test once while subject is recruited.
30-sec sit -to-stand
Use 30-Second sit to stand to test leg strength and endurance.
- Sit in the middle of the chair.
- Place your hands on the opposite shoulder crossed, at the wrists.
- Keep your feet flat on the floor.
- Keep your back straight, and keep your arms against your chest.
- On "Go," rise to a full standing position, then sit back down again.
- Repeat this for 30 seconds.
- Record the repetitions is performed.
Measured: Test once while subject is recruited.
Euro QOL-5D
The Euro QOL-5D (EQ-5D) comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem).
A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores.
The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analog scale (VAS) to indicate the general health status with 100 indicating the best health status.
Measured: Test once while subject is recruited.
International Physical Activity Questionnaire (IPAQ)
IPAQ comprises a set of 4 questionnaires and will ask about the time the subject spent being physically active in the last 7 days.
Three levels (categories) of physical activity are proposed:
Category 1: Low Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive.
Category 2: Moderate
Any one of the following 3 criteria:
- 3 or more days of vigorous activity of at least 20 minutes per day OR
- 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
- 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
Category 3: High
Any one of the following 2 criteria:
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR
- 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Measured: Test once while subject is recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Jan 2019
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TaSen Wei, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842215
- Sponsor's protocol ID
- CCH-181211
- Status last verified
- Jun 2021
- First submitted
- 13 Feb 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only for search
Publications
Arias-Palencia NM, Solera-Martinez M, Gracia-Marco L, Silva P, Martinez-Vizcaino V, Canete-Garcia-Prieto J, Sanchez-Lopez M. Levels and Patterns of Objectively Assessed Physical Activity and Compliance with Different Public Health Guidelines in University Students. PLoS One. 2015 Nov 4;10(11):e0141977. doi: 10.1371/journal.pone.0141977. eCollection 2015.
PubMed 26536605Choi JS, Kang DW, Seo JW, Kim DH, Yang ST, Tack GR. The development and evaluation of a program for leg-strengthening exercises and balance assessment using Kinect. J Phys Ther Sci. 2016 Jan;28(1):33-7. doi: 10.1589/jpts.28.33. Epub 2016 Jan 30.
PubMed 26957724Franz-Ritscherle A, Lange DE. [Effectiveness of various audiovisual technics to improve oral hygiene behavior]. Dtsch Zahnarztl Z. 1983 Sep;38(9):811-5. No abstract available. German.
PubMed 6196174Handrigan GA, Maltais N, Gagne M, Lamontagne P, Hamel D, Teasdale N, Hue O, Corbeil P, Brown JP, Jean S. Sex-specific association between obesity and self-reported falls and injuries among community-dwelling Canadians aged 65 years and older. Osteoporos Int. 2017 Feb;28(2):483-494. doi: 10.1007/s00198-016-3745-x. Epub 2016 Aug 25.
PubMed 27562568Jorgensen MG. Assessment of postural balance in community-dwelling older adults - methodological aspects and effects of biofeedback-based Nintendo Wii training. Dan Med J. 2014 Jan;61(1):B4775.
PubMed 24393594Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.
PubMed 23114461King AC, Taylor CB, Haskell WL, Debusk RF. Strategies for increasing early adherence to and long-term maintenance of home-based exercise training in healthy middle-aged men and women. Am J Cardiol. 1988 Mar 1;61(8):628-32. doi: 10.1016/0002-9149(88)90778-3.
PubMed 3344690Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.
PubMed 25364238Palacios-Cena D, Ortiz-Gutierrez RM, Buesa-Estellez A, Galan-Del-Rio F, Cachon Perez JM, Martinez-Piedrola R, Velarde-Garcia JF, Cano-DE-LA-Cuerda R. Multiple sclerosis patients' experiences in relation to the impact of the kinect virtual home-exercise programme: a qualitative study. Eur J Phys Rehabil Med. 2016 Jun;52(3):347-55. Epub 2016 Feb 17.
PubMed 26883340Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.
PubMed 19276189Schutzer KA, Graves BS. Barriers and motivations to exercise in older adults. Prev Med. 2004 Nov;39(5):1056-61. doi: 10.1016/j.ypmed.2004.04.003.
PubMed 15475041Walston J, McBurnie MA, Newman A, Tracy RP, Kop WJ, Hirsch CH, Gottdiener J, Fried LP; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med. 2002 Nov 11;162(20):2333-41. doi: 10.1001/archinte.162.20.2333.
PubMed 12418947
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Applications of a Smart Physical Examination System for the Health Management in Elderly
- ClinicalTrials.gov ID
- NCT03842215
- Acronym / sponsor ID
- CCH-181211
- Conditions
- Physical Activity
- Keywords
- smart physical examination system, health management, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 15 Feb 2019 (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.
The object of this study is to develop a smart physical examination system targeted on the unmet need of the elderly.Furthermore,the ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
Detailed description
Aging usually results in a decline of motor function. However, elderly tends to refuse the regular health examination because of travel issues or lack of self-health awareness. Examination unit also has difficulty to intensively track and instantly feedback the health status of elderly due to insufficient manpower. If elderly goes to the hospital only when the health problem is getting worse, his/her health is often irreversible and the cost of medical care would be increased. It is therefore an essential issue for the early detection of functional changes in elderly to prevent the deterioration of the health and function. Currently, the telemedicine cares provided by hospitals are not universal due to the out-of-date legislation and non-successful business model. The wearing and operation issues of the wearable devices used for health management are still a gap affecting the acceptance of elderly. Accordingly, the objective of this project is to develop a handy and easy-to-use smart physical examination system targeted on the unmet need of the elderly. With the use of motion-sensing and big data analysis technology, the non-contact professional and intelligent assessment could simplify the general health checkup procedures to promote the health management and to reduce the manpower cost of health care. Following the principle of commercialization, this project aims at working out the product prototype, finalize the assessment tools/algorithm, and put it into the clinical trials. The project research team comprising the physicians, therapists, hardware and software systems engineering experts, with the early manufacturing involvement from the industry partner. The team members will work closely to solve the clinical, engineering, and market demand issues during the development process. The project will build a platform to deepen the bilateral understanding and research cooperation to solve the aging society problem. The ultimate goal is to realize a commercial product aiming at the silver hair market with functional advantages to meet the unmet needs of health management in elderly.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| silver hair people | – | Device: smart physical examExam subject's physical function by a smart physical exam |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling people who are recruited from the local community, hospital, club.
Key inclusion criteria (1 listed)
- 1.55-85 years old 2.people who can do movement by 3.people who can walk >10m independently.
Key exclusion criteria (4 listed)
- people who implant cardiac rhythm, have cardiac arrhythmia,tumor,infection,or any other internal disease.
- people who have visual disturbance (Corrected vision<4.0 or any ophthalmic diseases caused bad eyesight),hearing loss,movement disorder.
- people who can't stand stably.
- people who can't fill out a questionnaire independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart physical examUse smart physical exam to collect functional performance | Device | silver hair people |
Primary outcome
Single Leg Balance Test
Time frame: Test once while subject is recruited.
Remove the shoes and stand on the floor. Stand on one leg for 60 seconds and record the duration (seconds) that subject keeps one leg stand. The test is stopped 1. if the legs touch each other, 2. if the weight-bearing foot moves on the floor, 3. if the non-weight bearing foot touches the floor 4. if the hands are removed from the waist.
Functional Reach Test
Time frame: Test once while subject is recruited.
Position the patient close to the wall. The patient is instructed to stand with feet shoulder distance apart then make a fist and raise the arm up so that it's parallel to the floor. At this time, the practitioner takes an initial reading on the yardstick, usually spotting the knuckle of the third metacarpal. The patient is instructed to reach forward along the yardstick without moving the feet, the hand should remain in a fist. The practitioner takes a reading on the yardstick of the farthest reach (cm) attained by the patient without taking a step.
Chair Sit and Reach Test
Time frame: Test once while subject is recruited.
The subject sits on the edge of a chair. One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Place one hand on top of the other with tips of the middle fingers even. Instruct the subject to Inhale, and then as they exhale, reach forward toward the toes by bending at the hip. Keep the back straight and head up. Keep the knee straight, and hold the reach for 2 seconds. The distance is measured between the tip of the fingertips and the toes. If the fingertips touch the toes then the score is zero. If they do not touch, measure the distance between the fingers and the toes (a negative score), if they overlap, measured by how much (a positive score). Perform two trials. The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Record which leg was used for measurement.
2 minute step
Time frame: Test once while subject is recruited.
The subject stands up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the patella (knee cap) and iliac crest (top of the hip bone). The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Resting is allowed, and holding onto the wall or a stable chair is allowed. Stop after two minutes of stepping, and measure the heart rate (beats/min).
Arm Curl Test
Time frame: Test once while subject is recruited.
The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side. The subject sits on the chair, holding the weight in the hand using a suitcase grip with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving. Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. The arm must be fully bent and then fully straightened at the elbow. Repeat this action as many times as possible within 30 seconds. The repetitions of arm curl are recorded.
30-sec sit -to-stand
Time frame: Test once while subject is recruited.
Use 30-Second sit to stand to test leg strength and endurance. 1. Sit in the middle of the chair. 2. Place your hands on the opposite shoulder crossed, at the wrists. 3. Keep your feet flat on the floor. 4. Keep your back straight, and keep your arms against your chest. 5. On "Go," rise to a full standing position, then sit back down again. 6. Repeat this for 30 seconds. 7. Record the repetitions is performed.
Euro QOL-5D
Time frame: Test once while subject is recruited.
The Euro QOL-5D (EQ-5D) comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analog scale (VAS) to indicate the general health status with 100 indicating the best health status.
International Physical Activity Questionnaire (IPAQ)
Time frame: Test once while subject is recruited.
IPAQ comprises a set of 4 questionnaires and will ask about the time the subject spent being physically active in the last 7 days. Three levels (categories) of physical activity are proposed: Category 1: Low Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive. Category 2: Moderate Any one of the following 3 criteria: * 3 or more days of vigorous activity of at least 20 minutes per day OR * 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR * 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. Category 3: High Any one of the following 2 criteria: * Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR * 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 26536605Arias-Palencia NM, Solera-Martinez M, Gracia-Marco L, Silva P, Martinez-Vizcaino V, Canete-Garcia-Prieto J, Sanchez-Lopez M. Levels and Patterns of Objectively Assessed Physical Activity and Compliance with Different Public Health Guidelines in University Students. PLoS One. 2015 Nov 4;10(11):e0141977. doi: 10.1371/journal.pone.0141977. eCollection 2015.
- Background: PubMed 26957724Choi JS, Kang DW, Seo JW, Kim DH, Yang ST, Tack GR. The development and evaluation of a program for leg-strengthening exercises and balance assessment using Kinect. J Phys Ther Sci. 2016 Jan;28(1):33-7. doi: 10.1589/jpts.28.33. Epub 2016 Jan 30.
- Background: PubMed 6196174Franz-Ritscherle A, Lange DE. [Effectiveness of various audiovisual technics to improve oral hygiene behavior]. Dtsch Zahnarztl Z. 1983 Sep;38(9):811-5. No abstract available. German.
- Background: PubMed 27562568Handrigan GA, Maltais N, Gagne M, Lamontagne P, Hamel D, Teasdale N, Hue O, Corbeil P, Brown JP, Jean S. Sex-specific association between obesity and self-reported falls and injuries among community-dwelling Canadians aged 65 years and older. Osteoporos Int. 2017 Feb;28(2):483-494. doi: 10.1007/s00198-016-3745-x. Epub 2016 Aug 25.
- Background: PubMed 24393594Jorgensen MG. Assessment of postural balance in community-dwelling older adults - methodological aspects and effects of biofeedback-based Nintendo Wii training. Dan Med J. 2014 Jan;61(1):B4775.
- Background: PubMed 23114461Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.
- Background: PubMed 3344690King AC, Taylor CB, Haskell WL, Debusk RF. Strategies for increasing early adherence to and long-term maintenance of home-based exercise training in healthy middle-aged men and women. Am J Cardiol. 1988 Mar 1;61(8):628-32. doi: 10.1016/0002-9149(88)90778-3.
- Background: PubMed 25364238Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.
- Background: PubMed 26883340Palacios-Cena D, Ortiz-Gutierrez RM, Buesa-Estellez A, Galan-Del-Rio F, Cachon Perez JM, Martinez-Piedrola R, Velarde-Garcia JF, Cano-DE-LA-Cuerda R. Multiple sclerosis patients' experiences in relation to the impact of the kinect virtual home-exercise programme: a qualitative study. Eur J Phys Rehabil Med. 2016 Jun;52(3):347-55. Epub 2016 Feb 17.
- Background: PubMed 19276189Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.
- Background: PubMed 15475041Schutzer KA, Graves BS. Barriers and motivations to exercise in older adults. Prev Med. 2004 Nov;39(5):1056-61. doi: 10.1016/j.ypmed.2004.04.003.
- Background: PubMed 12418947Walston J, McBurnie MA, Newman A, Tracy RP, Kop WJ, Hirsch CH, Gottdiener J, Fried LP; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med. 2002 Nov 11;162(20):2333-41. doi: 10.1001/archinte.162.20.2333.
- Individual participant dataSharing planned: No. only for search
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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.
TaSen Wei principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Changhua Christian Hospital at 1 site 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PangTa Liu (886-4-7238598 ext. 7427, 105546@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Leg Balance Test (time frame: Test once while subject is recruited.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842215, which also lists 12 linked publications.
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 2 Jul 2021.