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临床试验/NCT07553897
NCT07553897已完成不适用

Effectiveness of a Tele-Exercise Training Program on Long COVID Symptoms and Quality of Life in Patients With Long COVID

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Long COVID Symptoms

研究概览

简要总结

Patients with long coronavirus disease (COVID-19) experience multisystem symptoms and reduced quality of life (QOL). Proactive interventions are needed to enhance health outcomes.To investigate the effects of a 12-week tele-exercise training program on long COVID symptoms, cardiorespiratory fitness, and QOL.

详细描述

Long COVID is a multi-organ condition with persistent or delayed symptoms lasting weeks after infection, affecting physical and psychological function and reducing quality of life. It can occur regardless of age or initial disease severity, with prevalence ranging from 30% to 87.4%. Common symptoms include fatigue, cardiopulmonary issues, and neurological problems, collectively impairing daily functioning and mental health.

Exercise-based rehabilitation, including tele-exercise training, has emerged as a practical management strategy and may improve symptoms, cardiorespiratory fitness, and quality of life. However, current evidence remains limited due to small sample sizes and inconsistent protocols. Therefore, this study evaluated the effects of a 12-week tele-exercise program on symptoms, fitness, and quality of life in Taiwanese patients with long COVID compared with usual care.

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
Double (Investigator, 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

入选标准

  • Aged 20-80 years
  • Diagnosed with long COVID based on the criteria of the World Health Organization
  • Able to speak and understand Mandarin
  • Able to ambulate independently
  • Owns a mobile phone with Internet access
  • Willing to participate and undergo randomization

排除标准

  • History of arrhythmia
  • History of mental illness
  • Pregnancy
  • Acute or unstable chronic diseases (e.g., recent stroke, ongoing cancer treatment, end-stage renal disease requiring dialysis, or major surgery within the previous 3 months) Comorbid neurological or musculoskeletal conditions (e.g., stroke, Parkinson's disease, or dementia) resulting in moderate-to-severe physical disability

研究组 & 干预措施

Telehealth exercise training

Experimental

Telehealth exercise training for 12 weeks

干预措施: Telehealth exercise training program (Device)

Education and self-exercise

Active Comparator

usual outpatient care for 12 weeks

干预措施: Education and self-exercise (Behavioral)

结局指标

主要结局

Long COVID Symptoms

时间窗: 12 weeks

Common long COVID symptoms, based on the participants' subjective reports, include fatigue, shortness of breath, cough, chest pain, palpitations, brain fog, headaches, sleep disturbances, dizziness, changes in taste or smell, and depression or anxiety; these were assessed by a physician using a checklist with a binary response (present or absent).

Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)

时间窗: 12 weeks

Participants will undergo cardiopulmonary exercise testing using a motorized cycle ergometer with an incremental ramp protocol (10 W/min). The test will continue until participants report physical exhaustion or reach maximal exercise capacity, defined by respiratory exchange ratio criteria. Peak oxygen uptake (VO₂peak, mL/kg/min) will be estimated from maximal cardiac output and oxygen utilization and identified when oxygen consumption plateaus despite increasing exercise intensity. Unit of Measure: mL/kg/min

Cardiorespiratory Fitness - Peak Workload

时间窗: 12 weeks

During cardiopulmonary exercise testing, peak workload (watts) will be recorded as the highest workload achieved on the cycle ergometer. This reflects participants' ability to tolerate increasing exercise intensity. Unit of Measure: watts

Cardiorespiratory Fitness - Anaerobic Threshold

时间窗: 12 weeks

Anaerobic threshold (AT, mL/kg/min) will be determined during cardiopulmonary exercise testing as the point at which energy production begins to shift from aerobic to anaerobic metabolism. Unit of Measure: mL/kg/min

Health-Related Quality of Life

时间窗: 12 weeks

The brief World Health Organization Quality of Life questionnaire includes 26 standardized items covering four domains: physical, psychological, social, and environmental. It also contains two general items assessing overall quality of life and general health. The Taiwanese version adds two culturally specific items related to social respect/acceptance and eating/food. All items are rated on a 5-point Likert scale, where higher scores reflect better quality of life. Scores for each domain are calculated by averaging the item scores within that domain and then multiplying by 4, yielding a final score range from 4 to 20.

次要结局

  • Safety and adverse events(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia-Ying Lai

Doctor

Tri-Service General Hospital

研究点 (1)

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