Degeneration MuscleNCT04022590
Cardiopulmonary Training in the Victims With Multiple Morbidities by Application of Novel Heart Rate Sensing Clothes
A study testing E-clothes and Healthy consultation in people with Degeneration Muscle and Multiple Morbidities, run by Shang-Lin Chiang at 1 site in Taiwan.
Trial summary
Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degeneration Muscle, Multiple Morbidities, Heart; Complications
- What is being tested?
- E-clothes and Healthy consultation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2019to 31 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than two chronic disease.(multiple morbidity)
- able to speak and understand Mandarin
- able to walk without assistance
- able to use smart phones and understand how to use the e-clothes and related app
- agreed to be randomized to one of the two groups
Who cannot join
- a history of cancer
- confirmed psychiatric disease
- inability to participate due to comorbid neurological and musculoskeletal conditions
- a history of arrhythmia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-service General Hospital
Taipei, 115
Department of Rehabilitation
About this study
Official title: Tri-service General Hospital
Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from the clothes. Therefore, investigators try to conduct a feasibility study to evaluate the reliability and validity of the exercise heart rate sensing e-clothes and after that, investigators will incorporate this wearable clothes to home-based exercise training as one of the major components in our case management model.
Read the detailed description
Easy-to-use and service touch points allow patients/ users to realize the value and status of their physiological functions/ parameters based on their evidence is important. According to the U.S. survey, 90% of people can change their lifestyle behaviors, improve their personal health awareness, achieve holistic health care and improve their quality of life due to "Quantify Self". Therefore, a broader health care system, health consumption services or ecological system has been building to integrate health care resources, extend health care services from hospital to communities and individual' homes. When people consume in their daily life, immediate public health guidance or professional intervention can be offered at the same time, not only can effectively maintain individuals' health, early detection of possible physiological signs/ parameters, can also delay the progression of the disease and reduce the burden of first-line health care workers. Therefore, it is the era of smart healthcare that provides a health service platform with APPs(Applications) to provide personalized integrated medical services. However, in order to monitor or evaluate the effect of treatment (i.e., exercise training) still needs to be provided through the actual feedback of individual physiological data.
Clothes with smart function which is able to connect with social media and APPs has been promoting and marketing as smart sports or lifestyle-monitor goods, such as exercise-related physical parameters and sleep quality quantifying. Sleep physiology information collected through the clothes including degree and quality of sleep can be recorded and transmitted to the remote health system via APP and cloud service platform. On this cloud platform, health information can exchange with clinician's physicians, offering advises for users to whether to go to the hospital for further examination.
- Being tested
- E-clothes, Healthy consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-clothesDevice
The E-clothes could prove heart rate or heart rate variability(HRV) information to the participants' smart phone by blue tooth. Then the smart phone will calculate and provide the suitable aerobic training intensity by the microphone when the participants do aerobic training.
Healthy consultationBehavioural
Healthy consultation will educate the participants do aerobic training three times a week for 3 months. And the each training period is at least 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| E-clothes | Experimental | The participants with E-clothes do aerobic training at home Receives: Device: E-clothes; Behavioral: Healthy consultation |
| Home exercise | Active comparator | The participants with healthy consultation do aerobic training at home. Receives: Behavioral: Healthy consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity (VO2 max in ml/kg/min )
Maximal VO2 during testing, also means aerobic capacity
Measured: 30 minutes
Working load in watt
Maximal Working load during testing
Measured: 30 minutes
Rest/Max Heart rate in beat/min
resting and maximal heart rate during exercise testing,
Measured: 30 minutes
O2 pulse in ml/beat,
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Measured: 30 minutes
systolic and diastolic blood pressure in mm Hg,
The resting and maximal blood pressure during exercise testing
Measured: 30 minutes
Secondary outcomes (1)
Physical activity (scores)
The participants' weekly physical activity will be assessed by a research nurse using the International Physical Activity Questionnaire (IPAQ)-short form, Chinese version, which has well-established reliability and validity (Liou, Jwo, Yao, Chiang, \& Huang, 2008). This 7-item instrument measures time (minute) of physical activity including housework, transportation, leisure activity, and moderate-to-vigorous-intensity physical activity for the past 7 days.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start8 Jul 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration MuscleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shang-Lin Chiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shang-Lin Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022590
- Sponsor's protocol ID
- Smart clothes
- Status last verified
- Sep 2023
- First submitted
- 18 May 2019
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-service General Hospital
- ClinicalTrials.gov ID
- NCT04022590
- Acronym / sponsor ID
- Smart clothes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shang-Lin ChiangUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jul 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.
Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from the clothes. Therefore, investigators try to conduct a feasibility study to evaluate the reliability and validity of the exercise heart rate sensing e-clothes and after that, investigators will incorporate this wearable clothes to home-based exercise training as one of the major components in our case management model.
Detailed description
Easy-to-use and service touch points allow patients/ users to realize the value and status of their physiological functions/ parameters based on their evidence is important. According to the U.S. survey, 90% of people can change their lifestyle behaviors, improve their personal health awareness, achieve holistic health care and improve their quality of life due to "Quantify Self". Therefore, a broader health care system, health consumption services or ecological system has been building to integrate health care resources, extend health care services from hospital to communities and individual' homes. When people consume in their daily life, immediate public health guidance or professional intervention can be offered at the same time, not only can effectively maintain individuals' health, early detection of possible physiological signs/ parameters, can also delay the progression of the disease and reduce the burden of first-line health care workers. Therefore, it is the era of smart healthcare that provides a health service platform with APPs(Applications) to provide personalized integrated medical services. However, in order to monitor or evaluate the effect of treatment (i.e., exercise training) still needs to be provided through the actual feedback of individual physiological data.
Clothes with smart function which is able to connect with social media and APPs has been promoting and marketing as smart sports or lifestyle-monitor goods, such as exercise-related physical parameters and sleep quality quantifying. Sleep physiology information collected through the clothes including degree and quality of sleep can be recorded and transmitted to the remote health system via APP and cloud service platform. On this cloud platform, health information can exchange with clinician's physicians, offering advises for users to whether to go to the hospital for further examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| E-clothes | Experimental | Device: E-clothes, Behavioral: Healthy consultationThe participants with E-clothes do aerobic training at home |
| Home exercise | Active comparator | Behavioral: Healthy consultationThe participants with healthy consultation do aerobic training at home. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- more than two chronic disease.(multiple morbidity)
- able to speak and understand Mandarin
- able to walk without assistance
- able to use smart phones and understand how to use the e-clothes and related app
- agreed to be randomized to one of the two groups
Key exclusion criteria (4 listed)
- a history of cancer
- confirmed psychiatric disease
- inability to participate due to comorbid neurological and musculoskeletal conditions
- a history of arrhythmia
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 |
|---|---|---|
| E-clothesThe E-clothes could prove heart rate or heart rate variability(HRV) information to the participants' smart phone by blue tooth. Then the smart phone will calculate and provide the suitable aerobic training intensity by the microphone when the participants do aerobic training. | Device | E-clothes |
| Healthy consultationHealthy consultation will educate the participants do aerobic training three times a week for 3 months. And the each training period is at least 30 minutes. | Behavioural | E-clothes, Home exercise |
Primary outcome
Aerobic capacity (VO2 max in ml/kg/min )
Time frame: 30 minutes
Maximal VO2 during testing, also means aerobic capacity
Working load in watt
Time frame: 30 minutes
Maximal Working load during testing
Rest/Max Heart rate in beat/min
Time frame: 30 minutes
resting and maximal heart rate during exercise testing,
O2 pulse in ml/beat,
Time frame: 30 minutes
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
systolic and diastolic blood pressure in mm Hg,
Time frame: 30 minutes
The resting and maximal blood pressure during exercise testing
1 secondary outcome
Physical activity (scores)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-clothes and Healthy consultation in people with Degeneration Muscle and Multiple Morbidities, run by Shang-Lin Chiang 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 5 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 Oct 2023. 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 Shang-Lin Chiang, PhD (8860287923311 ext. 12677, andyyy520@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (VO2 max in ml/kg/min ) (time frame: 30 minutes). The study lists 5 primary outcomes in all. 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 2 Oct 2023.