The Effect of Smart Sensor Combined With APP for Individualized Precise Exercise Training in Long Covid-19

Study Overview
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Brief Summary
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The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Previous research has indicated that these subsequent sequelae can reduce quality of life. (A. W. Wong et al., 2020) Studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (J. Galloza et al., 2017) However, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with COVID-19 is still lacking. Under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. Previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. The purpose of this study is to compare the effect between the intervention of KNEESUP smart knee assistive device, the use of the APP, and the health education in routine outpatient after diagnosis of Long Covid-19.

Detailed Description
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The purpose of KNEESUP measuring equipment used in this research is to improve the recovery rate and reduce the sequelae after treatment. KNEESUP connects the subjects and researchers through technologies such as IoT and AI. The evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented. For the subject, the subject puts on KNEESUP knee pads in a long sitting position, bends the knees about 30 degrees, aligns the position of the knee pad circle with the bone, and uses the strap on the lower side, upper side, and the knee pads. After wearing, press and hold the sensor on the outer side of the knee pad for 3 seconds, and then open the mobile app. After the hardware setting and connection are completed, the evaluation and exercise can begin.

Official Title
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Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan

Conditions
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Coronavirus Disease, COVID-19, Long Covid-19, Telerehabilitation

Intervention / Treatment
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* Device: KNEESUP smart knee assistive device + KNEESUP care APP
* Device: KNEESUP care APP
* Behavioral: Healthy consulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptoms last one month after recovery without physical impairment understood verbal or non-verbal communication normal cognitive function were willing to participate in the study and accept random allocation Exclusion Criteria: diagnosed with transient ischemic attack or stroke had neuromuscular injury or surgery in the lower limbs in the past six months had heart rhythm regulator hospitalized during training had aggravated symptoms due to infection again had participated in other clinical trials or received other alternative treatments

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KNEESUP smart knee assistive device + KNEESUP care APP<br>The participants with KNEESUP smart knee assistive device and KNEESUP care APP do exercise training at home. | Device: KNEESUP smart knee assistive device + KNEESUP care APP<br>* In KNEESUP smart knee assistive device + KNEESUP care APP group, participants used the KNEESUP intelligent knee assistive device. Participants wore a knee brace with a sensor module on one side of the leg, the sensor could connect with the KNEESUP care APP which were installed in participant's mobile phone. The APP was designed with an individualized exercise program and the knee brace sensor could detect the action moment of the participants during exercise. This equipment could help the participants to achieve professional-level home rehabilitation.<br>|
| Active Comparator: KNEESUP care APP<br>The participants with KNEESUP care APP do exercise training at home. | Device: KNEESUP care APP<br>* In KNEESUP care APP group, the participants only used the KNEESUP care APP which was installed in the mobile phone. The APP was designed with an individualized exercise program. Participants could follow the APP to do the exercise program according to their own conditions.<br>|
| Placebo Comparator: Health consultation<br>The participants with healthy consultation do aerobic training at home. | Behavioral: Healthy consulation<br>* In Healthy consulation group, participants received routine outpatient health education.<br>|

What is the study measuring?
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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 |