Clinical trial NCT05922865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Disease
COVID-19
Long Covid-19
Telerehabilitation
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: Inclusion Criteria:

* symptoms last at least 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

Primary outcomes:
measure: Aerobic capacity (VO2 max in ml/kg/min )
timeFrame: baseline, 12 weeks
measure: Anaerobic Threshold (mL/kg/min)
timeFrame: baseline, 12 weeks
measure: Working load in watt
timeFrame: baseline, 12 weeks
measure: Breathing reserve (ml/kg/min)
timeFrame: baseline, 12 weeks
measure: Rest Heart rate in beat/min
timeFrame: baseline, 12 weeks
measure: O2 pulse in ml/beat
timeFrame: baseline, 12 weeks
measure: Systolic blood pressure in mm Hg
timeFrame: baseline, 12 weeks
measure: Diastolic blood pressure in mm Hg
timeFrame: baseline, 12 weeks
measure: VE/VCO2 slope
timeFrame: baseline, 12 weeks
measure: Heart rate recovery
timeFrame: baseline, 12 weeks
measure: FVC (L/min)
timeFrame: baseline, 12 weeks
measure: FEV1 (L/min)
timeFrame: baseline, 12 weeks
measure: FEV1/FVC (%)
timeFrame: baseline, 12 weeks
measure: Gait: Step length (m) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Speed (m/s) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Cadence (steps per minute) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Left gait cycle (sec) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Right gait cycle (sec) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Turn around time (sec) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Stand up time (sec) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Gait: Total walking time (sec) through Time Up and Go Test
timeFrame: baseline, 12 weeks
measure: Long COVID symptoms
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Quality of life (scores)
timeFrame: baseline, 12 weeks
measure: Sleeping Quality (scores)
timeFrame: baseline, 12 weeks
measure: Body composition: Body weight (kg)
timeFrame: baseline, 12 weeks
measure: Body composition: Body fat (%)
timeFrame: baseline, 12 weeks
measure: Body composition: Lean mass weight (kg)
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service General Hospital
Study officials:
References: