Cardiopulmonary Training in the Victims With Multiple Morbidities by Application of Novel Heart Rate Sensing Clothes

NCT ID: NCT04022590

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2024-12-31

Brief 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 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.

Conditions

Degeneration Muscle; Multiple Morbidities; Heart; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

E-clothes

The participants with E-clothes do aerobic training at home

Group Type: EXPERIMENTAL

E-clothes

Intervention Type: DEVICE

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 consultation

Intervention Type: BEHAVIORAL

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.

Home exercise

The participants with healthy consultation do aerobic training at home.

Group Type: ACTIVE_COMPARATOR

Healthy consultation

Intervention Type: BEHAVIORAL

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.

Interventions

E-clothes

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.

Intervention Type: DEVICE

Healthy consultation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• a history of cancer
• confirmed psychiatric disease
• inability to participate due to comorbid neurological and musculoskeletal conditions
• a history of arrhythmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shang-Lin Chiang

OTHER

Sponsor Role: lead

Responsible Party

Shang-Lin Chiang

Attending physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tri-service General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shang-Lin Chiang, PhD

Role: CONTACT

andyyy520@yahoo.com.tw

8860287923311 ext. 12677

Liang-Hsuan Lu, MS

Role: CONTACT

katelinana@gmail.com

8860287923311 ext. 17070

Facility Contacts

Department of Rehabilitation

Role: primary

Other Identifiers

Smart clothes

Identifier Type: -

Identifier Source: org_study_id