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

NCT05922865 | Completed

• 1 other identifier: smart knee assistive device
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease; COVID-19; Long Covid-19; Telerehabilitation

Outcome Measures

Primary Outcomes (22)

• Aerobic capacity (VO2 max in ml/kg/min )

  Maximal VO2 during testing, also means aerobic capacity

  baseline, 12 weeks

• Anaerobic Threshold (mL/kg/min)

  Anaerobic Threshold (AT) refers to the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be removed. It represents a transition point between predominantly aerobic metabolism (using oxygen) and increased anaerobic metabolism (without sufficient oxygen).

  baseline, 12 weeks

• Working load in watt

  Maximal Working load during testing

  baseline, 12 weeks

• Breathing reserve (ml/kg/min)

  A measure used during cardiopulmonary exercise testing (CPET) to assess how much of a person's maximum ventilatory capacity is unused at peak exercise. It reflects the difference between the maximum voluntary ventilation (MVV) and the minute ventilation (VE) reached during exercise.

  baseline, 12 weeks

• Rest Heart rate in beat/min

  Resting heart rate during exercise testing

  baseline, 12 weeks

• O2 pulse in ml/beat

  It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.

  baseline, 12 weeks

• Systolic blood pressure in mm Hg

  The resting blood pressure during exercise testing

  baseline, 12 weeks

• Diastolic blood pressure in mm Hg

  The resting blood pressure during exercise testing

  baseline, 12 weeks

• VE/VCO2 slope

  The ventilation/ perfusion abnormalities (VE/VCO2) is measured by graded exercise testing.The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.

  baseline, 12 weeks

• Heart rate recovery

  The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery. The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \< 12 or 22 beats per minute in 1- or 2- min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.

  baseline, 12 weeks

• FVC (L/min)

  The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.

  baseline, 12 weeks

• FEV1 (L/min)

  The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV1 was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1 indicates better lung function.

  baseline, 12 weeks

• FEV1/FVC (%)

  The measured FEV1 is divided by the measured FVC. he change in FEV1/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.

  baseline, 12 weeks

• Gait: Step length (m) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Speed (m/s) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Cadence (steps per minute) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Left gait cycle (sec) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Right gait cycle (sec) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Turn around time (sec) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Stand up time (sec) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Gait: Total walking time (sec) through Time Up and Go Test

  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).

  baseline, 12 weeks

• Long COVID symptoms

  A simple checklist to record Long COVID symptoms. Symptoms that persisted or were newly developed after acute infection were documented as sequelae. Symptoms included fatigue, shortness of breath, cognitive dysfunction (referred to as "brain fog"), chest pain, cough, dizziness, headache, sleep disturbances, palpitations, depression/anxiety, and olfactory dysfunction.

  baseline, 12 weeks

Secondary Outcomes (5)

• Quality of life (scores)

  baseline, 12 weeks

• Sleeping Quality (scores)

  baseline, 12 weeks

• Body composition: Body weight (kg)

  baseline, 12 weeks

• Body composition: Body fat (%)

  baseline, 12 weeks

• Body composition: Lean mass weight (kg)

  baseline, 12 weeks

Study Arms (2)

KNEESUP smart knee assistive device + KNEESUP care APP

EXPERIMENTAL

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

Health consultation

PLACEBO COMPARATOR

The participants with healthy consultation do exercise training at home.

Behavioral: Healthy consulation

Interventions

KNEESUP smart knee assistive device + KNEESUP care APP DEVICE

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.

KNEESUP smart knee assistive device + KNEESUP care APP

Healthy consulation BEHAVIORAL

In Healthy consulation group, participants received routine outpatient health education.

Health consultation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shang-Lin Chiang: lead

Study Sites (1)

Tri-service General Hospital

Taipei, 115, Taiwan

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: June 28, 2023
• Study Start: July 11, 2023
• Primary Completion: February 27, 2024
• Study Completion: March 15, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)