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

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ClinicalTrials.gov Identifier: NCT05922865
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : October 2, 2023
Sponsor:
Information provided by (Responsible Party):
Shang-Lin Chiang, National Defense Medical Center, Taiwan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease COVID-19 Long Covid-19 Telerehabilitation Device: KNEESUP smart knee assistive device + KNEESUP care APP Device: KNEESUP care APP Behavioral: Healthy consulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: KNEESUP smart knee assistive device + KNEESUP care APP
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
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.
Active Comparator: KNEESUP care APP
The participants with KNEESUP care APP do exercise training at home.
 Device: KNEESUP care APP
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.
Placebo Comparator: Health consultation
The participants with healthy consultation do aerobic training at home.
 Behavioral: Healthy consulation
In Healthy consulation group, participants received routine outpatient health education.


Outcome Measures
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Primary Outcome Measures :
  1. Aerobic capacity (VO2 max in ml/kg/min ) [ Time Frame: 30 minutes ]
    Maximal VO2 during testing, also means aerobic capacity

  2. Working load in watt [ Time Frame: 30 minutes ]
    Maximal Working load during testing

  3. Rest/Max Heart rate in beat/min [ Time Frame: 30 minutes ]
    resting and maximal heart rate during exercise testing

  4. O2 pulse in ml/beat [ Time Frame: 30 minutes ]
    It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.

  5. Systolic and diastolic blood pressure in mm Hg [ Time Frame: 30 minutes ]
    The resting and maximal blood pressure during exercise testing


Secondary Outcome Measures :
  1. Physical activity (scores) [ Time Frame: 10 minutes ]
    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.


Other Outcome Measures:
  1. Quality of life (scores) [ Time Frame: 10 minutes ]
    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).

  2. Sleeping Quality (scores) [ Time Frame: 10 minnutes ]
    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).

  3. Time Up and Go Test [ Time Frame: 10 minutes ]
    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).

  4. Balance test [ Time Frame: 10 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922865


Contacts
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Contact: Shang-Lin Chiang, PhD 8860287923311 ext 12677 andyyy520@yahoo.com.tw
Contact: Liang-Hsuan Lu, MS 8860287923311 ext 17070 katelinana@gmail.com

Locations
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Taiwan
Tri-service General Hospital Recruiting
Taipei, Taiwan, 115
Contact: Department of Rehabilitation         
Sponsors and Collaborators
Shang-Lin Chiang
More Information
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Responsible Party: Shang-Lin Chiang, Attending physician, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT05922865    
Other Study ID Numbers: smart knee assistive device
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Post-Acute COVID-19 Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Pathologic Processes