Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rest Heart rate in beat/min
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: KNEESUP smart knee assistive device + KNEESUP care APP (Device)
Health consultation
The participants with healthy consultation do exercise training at home.
干预措施: Healthy consulation (Behavioral)
结局指标
主要结局
Rest Heart rate in beat/min
时间窗: baseline, 12 weeks
Resting heart rate during exercise testing
Aerobic capacity (VO2 max in ml/kg/min )
时间窗: baseline, 12 weeks
Maximal VO2 during testing, also means aerobic capacity
Working load in watt
时间窗: baseline, 12 weeks
Maximal Working load during testing
O2 pulse in ml/beat
时间窗: baseline, 12 weeks
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Systolic blood pressure in mm Hg
时间窗: baseline, 12 weeks
The resting blood pressure during exercise testing
Diastolic blood pressure in mm Hg
时间窗: baseline, 12 weeks
The resting blood pressure during exercise testing
Anaerobic Threshold (mL/kg/min)
时间窗: baseline, 12 weeks
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).
Breathing reserve (ml/kg/min)
时间窗: baseline, 12 weeks
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.
VE/VCO2 slope
时间窗: baseline, 12 weeks
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.
Heart rate recovery
时间窗: baseline, 12 weeks
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.
FVC (L/min)
时间窗: baseline, 12 weeks
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.
FEV1 (L/min)
时间窗: baseline, 12 weeks
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.
FEV1/FVC (%)
时间窗: baseline, 12 weeks
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.
Gait: Step length (m) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Speed (m/s) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Cadence (steps per minute) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Left gait cycle (sec) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Right gait cycle (sec) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Turn around time (sec) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Stand up time (sec) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Gait: Total walking time (sec) through Time Up and Go Test
时间窗: baseline, 12 weeks
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).
Long COVID symptoms
时间窗: baseline, 12 weeks
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.
次要结局
- 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)
研究者
Shang-Lin Chiang
Attending physician
National Defense Medical Center, Taiwan