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

Primary Purpose

Coronavirus Disease, COVID-19, Long Covid-19

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
KNEESUP smart knee assistive device + KNEESUP care APP
KNEESUP care APP
Healthy consulation
Sponsored by
Shang-Lin Chiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tri-service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

KNEESUP smart knee assistive device + KNEESUP care APP

KNEESUP care APP

Health consultation

Arm Description

The participants with KNEESUP smart knee assistive device and KNEESUP care APP do exercise training at home.

The participants with KNEESUP care APP do exercise training at home.

The participants with healthy consultation do aerobic training at home.

Outcomes

Primary Outcome Measures

Aerobic capacity (VO2 max in ml/kg/min )
Maximal VO2 during testing, also means aerobic capacity
Working load in watt
Maximal Working load during testing
Rest/Max Heart rate in beat/min
resting and maximal heart rate during exercise testing
O2 pulse in ml/beat
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
The resting and maximal blood pressure during exercise testing

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2023
Last Updated
September 29, 2023
Sponsor
Shang-Lin Chiang
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1. Study Identification

Unique Protocol Identification Number
NCT05922865
Brief Title
The Effect of Smart Sensor Combined With APP for Individualized Precise Exercise Training in Long Covid-19
Official Title
Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shang-Lin Chiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease, COVID-19, Long Covid-19, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KNEESUP smart knee assistive device + KNEESUP care APP
Arm Type
Experimental
Arm Description
The participants with KNEESUP smart knee assistive device and KNEESUP care APP do exercise training at home.
Arm Title
KNEESUP care APP
Arm Type
Active Comparator
Arm Description
The participants with KNEESUP care APP do exercise training at home.
Arm Title
Health consultation
Arm Type
Placebo Comparator
Arm Description
The participants with healthy consultation do aerobic training at home.
Intervention Type
Device
Intervention Name(s)
KNEESUP smart knee assistive device + KNEESUP care APP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
KNEESUP care APP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy consulation
Intervention Description
In Healthy consulation group, participants received routine outpatient health education.
Primary Outcome Measure Information:
Title
Aerobic capacity (VO2 max in ml/kg/min )
Description
Maximal VO2 during testing, also means aerobic capacity
Time Frame
30 minutes
Title
Working load in watt
Description
Maximal Working load during testing
Time Frame
30 minutes
Title
Rest/Max Heart rate in beat/min
Description
resting and maximal heart rate during exercise testing
Time Frame
30 minutes
Title
O2 pulse in ml/beat
Description
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Time Frame
30 minutes
Title
Systolic and diastolic blood pressure in mm Hg
Description
The resting and maximal blood pressure during exercise testing
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Physical activity (scores)
Description
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.
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
Quality of life (scores)
Description
The indicator of quality of life in this study will use Taiwan Concise Version of the World Health Organization Quality of Life Questionnaire (WHOQOL) to evaluate. The Taiwan version development team led by Yao Kaiping developed a brief version of the questionnaire (WHOQOL-BREF) based on WHOQOL-100. The questionnaire includes 1 question measuring the overall quality of life, 1 question measuring general health, and 7 questions measuring the physical domain. , 6 questions measure the psychological domain (psychological domain), 3 questions measure the social relationship domain (social relationships domain), and 8 questions measure the environment domain (environment domain), and add 1 local question to the social relationship and environment domains, totaling 28 questions. The item is a 5-point scale, with higher scores indicating a higher quality of life. (Lin Lizhong, Su Yiqing, & Yao Kaiping, 2020; Yao Kaiping, 2002; Zhang Qianhui, Li Xinning, Zheng Yongfu, & Jin Huizhen, 2013).
Time Frame
10 minutes
Title
Sleeping Quality (scores)
Description
Symptoms of sleeping quality will be assessed using Pittsburgh Sleeping Index. The content is aimed at the sleep conditions of the subjects, including seven items including personal self-evaluation of sleep quality, sleep latency, sleep hours, sleep efficiency, sleep disturbance, drug use and daytime dysfunction. Each item is calculated by the Likert four-point method, 0-3 points, the total score ranges from 0-21 points, and the higher the score, the worse the sleep quality. (MORGAN, DALLOSSO, EBRAHIM, ARIE, & Fentem, 1988; Tang Zhenqing et al., 2014).
Time Frame
10 minnutes
Title
Time Up and Go Test
Description
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Time Frame
10 minutes
Title
Balance test
Description
Analysis software was evaluated using METASENS. The subjects were asked to do the one leg standing test with eyes opened and eyes closed in sequence. First ask the subjects to open their eyes, stand on one foot, raise their legs to knee height, keep their hands on their hips for balance, and stop timing when their feet stand on the ground. Then ask the subjects to close their eyes and repeat the above test content. The METASENS analysis software records the time (s) when the subject stands on one foot for balance, and analyzes the shaking amplitude (cm) in the forward, backward, left, and right directions when the subject stands on one foot.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shang-Lin Chiang, PhD
Phone
8860287923311
Ext
12677
Email
andyyy520@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Liang-Hsuan Lu, MS
Phone
8860287923311
Ext
17070
Email
katelinana@gmail.com
Facility Information:
Facility Name
Tri-service General Hospital
City
Taipei
ZIP/Postal Code
115
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Department of Rehabilitation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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