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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart; Complications; Degeneration Muscle; Multiple Morbidities
• Intervention / Treatment: Device: E-clothes; Behavioral: Healthy consultation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shang-Lin Chiang, PhD; Phone Number: 12677 8860287923311; Email: andyyy520@yahoo.com.tw
• Study Contact Backup: Name: Liang-Hsuan Lu, MS; Phone Number: 17070 8860287923311; Email: katelinana@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 115
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Department of Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-clothes; The participants with E-clothes do aerobic training at home	Device: 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.; Behavioral: 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.
Active Comparator: Home exercise; The participants with healthy consultation do aerobic training at home.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity (VO2 max in ml/kg/min )	Maximal VO2 during testing, also means aerobic capacity	30 minutes
Working load in watt	Maximal Working load during testing	30 minutes
Rest/Max Heart rate in beat/min	resting and maximal heart rate during exercise testing,	30 minutes
O2 pulse in ml/beat,	It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.	30 minutes
systolic and diastolic blood pressure in mm Hg,	The resting and maximal blood pressure during exercise testing	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (scores)	The indicator of quality of life in this study will use Short-Form 36 to evaluate. The Taiwan standard version SF-36 developed through the collaboration of Drs. Jui-Fen Rachel Lu et al. in 1996 showed well-established reliability and validity.	20 minutes
Depression (scores)	Symptoms of depression will be assessed using the 21-item BDI, which is a self-report questionnaire frequently used to examine depressive level during the previous two weeks (Beck, Steer, & Brown, 1996)	10 minnutes

Collaborators and Investigators

• Sponsor: Shang-Lin Chiang

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 18, 2019
• First Submitted That Met QC Criteria: July 13, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Smart clothes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No