- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840873
Tele-Rehabilitative Exercise Training Program in Nurses With Long COVID
October 1, 2025 updated by: Shang-Lin Chiang
Effectiveness of a 8-week Tele-Rehabilitative Exercise Training Program on Fatigue, Symptom Severity, and Quality of Life in Nurses With Long COVID: A Randomized Controlled Trial
Long COVID can cause a decline in cardiorespiratory fitness, resulting in fatigue and negative impacts on individuals' quality of life (QoL), particularly in nurses who play a crucial role in public health.
Combining with reduced cardiorespiratory fitness and suffering from a spectrum of long-COVID symptoms might substantially exaggertate fatigue, perceived stress, and reduce willingness to work for hospital nurses.
Therefore, this study aimed to evaluate the effectiveness of tele-rehabilitative exercise on fatigue, perceived stress, symptom severity of long COVID, and QoL in this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention is an extra 8-week tele-rehabilitative exercise program (3 aerobic and 2 strengthing exercise sessions/week at a moderate intensity, 30 min/session), monitored through a wearable devices and a mobile App.
The evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented.
Outcome measures were assessed at baseline, 4, and 8 weeks.
Cardiorespiratory fitness was measured before and after the intervention via cardiopulmonary exercise tests.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tiapei, Taiwan, 114
- Tri-Service General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- nurses older than 20 years of age
- have reported a positive result on a COVID-19 rapid test or nucleic acid test
- one or more of the following symptoms for more than four weeks: fatigue, discomfort after physical or mental exertion, fever, cardiopulmonary symptoms such as difficulty breathing or shortness of breath, cough, chest pain, or palpitations (CDC, 2022)
- able to perform activities independently without assistance
- total score of 36 or higher on the Fatigue Severity Scale (FSS), confirming fatigue symptoms, and report that these symptoms either appeared after the infection or worsened following the infection
Exclusion Criteria:
- without the equipment to install a mobile application (APP)
- unsuitable for wearing devices due to any leg diseases
- unable to engage in aerobic or strength training due to neurological or musculoskeletal disorders
- pregnancy
- cancer
- absolute and relative contraindications for cardiopulmonary testing or exercise training
- unsuitable for participation in this study by a rehabilitation specialist;
- regular exercisers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Health consultation
The participants with healthy consultation do aerobic training at home
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Participants received routine outpatient health education.
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Experimental: wearable device
The participants with wearable device do exercise training at home
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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, including 3 aerobic and 2 strengthening exercise sessions per week at a moderate intensity, 30 min/session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aerobic capacity (VO2 max in ml/kg/min )
Time Frame: 30 minutes
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Maximal VO2 during testing, also means aerobic capacity
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30 minutes
|
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Working load in watt
Time Frame: 30 minutes
|
Maximal Working load during testing
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30 minutes
|
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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.
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30 minutes
|
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Severity of long COVID symptoms (scores)
Time Frame: 10 minutes
|
This study uses the Chinese version of the Post-COVID-19 Functional Status Scale (PCFS) translated by Liao and Cheng (2023), which was originally developed by Frederikus A. Klok.
It assesses changes in daily living, work and study activities, social activities, and overall functional status over the past week (Klok et al., 2020).
The scale consists of two parts: the functional status scale and the symptom checklist.
The first part, the functional status scale, is divided into five levels from 0 to 4. The second part, the post-infection symptom checklist, checks for specific symptoms that appear after COVID-19 infection.
It is divided into five levels.
This checklist evaluates respiratory, cardiovascular, gastrointestinal, neurological, psychological, and musculoskeletal symptoms.
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10 minutes
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Fatigue (score)
Time Frame: 10 minutes
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The Chinese version of the Fatigue Severity Scale (CFSS) (Wang et al., 2016) assesses the severity of fatigue in the participants.
The scale is a self-administered questionnaire.
The scale evaluates the severity of fatigue symptoms and their impact on daily activities over the past two weeks.
It consists of 9 items, rated on a 7-point scale, with scores ranging from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement.
The minimum score is 9, and the maximum score is 63.
Higher scores indicate more severe fatigue, with a total score of 36 (inclusive) or higher indicating severe fatigue.
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10 minutes
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Heart rate recovery in beat/min
Time Frame: 30 minutes
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Heart rate recovery is measured by recording your heart rate immediately after stopping exercise, and then at intervals (e.g., 1 minute and 2 minutes) after the exercise ends, which reflects autonomic nervous system function.
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30 minutes
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Anaerobic threshold (AT in ml/kg/min)
Time Frame: 30 minutes
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The point during exercise at which lactate (a byproduct of anaerobic metabolism) starts to accumulate in the blood faster than it can be removed.
This indicates a shift from primarily aerobic energy production to more anaerobic energy production.
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life (scores)
Time Frame: baseline, 4, and 8 weeks
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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.
The total score ranges from 25 to 140.
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baseline, 4, and 8 weeks
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Perceived stress (scores)
Time Frame: baseline, 4, and 8 weeks
|
The Chinese version of the Perceived Stress Scale (PSS) measures the perception of stress (Chiu, 2012).
The original scale was developed by Cohen et al. (Cohen et al., 1983).
The Chinese version has shown good reliability and validity in a study of nurses in Taiwan, with a Cronbach's alpha of 0.73.
The scale is a self-administered questionnaire that measures the level of perceived stress in the past month.
It consists of 14 items, all rated using a Likert scale with five response options: "Never," "Occasionally," "Sometimes," "Often," and "Always" (0-4 points).
Seven of the items (4, 5, 6, 7, 9, 10, 13) are positive questions that need to be reverse-scored.
The total score ranges from 0 to 56, with higher scores indicating higher perceived stress.
A score of 0-28 is considered within the normal stress range, 29-37 indicates high stress, and 38-56 suggests the need to seek external support.
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baseline, 4, and 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2023
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
November 1, 2024
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
February 21, 2025
Study Record Updates
Last Update Posted (Estimated)
October 7, 2025
Last Update Submitted That Met QC Criteria
October 1, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Fatigue
- Motor Activity
- Equipment and Supplies
- Electrical Equipment and Supplies
- Wearable Electronic Devices
Other Study ID Numbers
- c202305117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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