Heart; Complications Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-service General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shang-Lin Chiang |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Primary | Aerobic capacity (VO2 max in ml/kg/min ) | Maximal VO2 during testing, also means aerobic capacity | 30 minutes | |
Primary | Working load in watt | Maximal Working load during testing | 30 minutes | |
Primary | Rest/Max Heart rate in beat/min | resting and maximal heart rate during exercise testing, | 30 minutes | |
Primary | O2 pulse in ml/beat, | It means the heart pumps O2 volume by each heart beat, and also means left ventricle function. | 30 minutes | |
Primary | systolic and diastolic blood pressure in mm Hg, | The resting and maximal blood pressure during exercise testing | 30 minutes | |
Secondary | 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 |
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