Cardiorespiratory FitnessNCT06840873
Tele-Rehabilitative Exercise Training Program in Nurses With Long COVID
A study testing wearable device and Healthy consulation in people with Cardiorespiratory Fitness and Exercise, run by Shang-Lin Chiang at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiorespiratory Fitness, Exercise, Long COVID
- What is being tested?
- wearable device and Healthy consulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiorespiratory Fitness, Exercise, Long COVID, Nurses, Quality of Life (QOL), Fatigue
- Being tested
- wearable device, Healthy consulation
- Medical subject headings
- Motor Activity, Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable deviceDevice
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.
Healthy consulationBehavioural
Participants received routine outpatient health education.
| Study group | Role | What they receive |
|---|---|---|
| Health consultation | Placebo comparator | The participants with healthy consultation do aerobic training at home Receives: Behavioral: Healthy consulation |
| wearable device | Experimental | The participants with wearable device do exercise training at home Receives: Device: wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue (score)
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.
Measured: 10 minutes
O2 pulse in ml/beat
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Measured: 30 minutes
Aerobic capacity (VO2 max in ml/kg/min )
Maximal VO2 during testing, also means aerobic capacity
Measured: 30 minutes
Working load in watt
Maximal Working load during testing
Measured: 30 minutes
Heart rate recovery in beat/min
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.
Measured: 30 minutes
Anaerobic threshold (AT in ml/kg/min)
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.
Measured: 30 minutes
Severity of long COVID symptoms (scores)
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.
Measured: 10 minutes
Secondary outcomes (2)
Quality of life (scores)
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.
Measured: baseline, 4, and 8 weeks
Perceived stress (scores)
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.
Measured: baseline, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start2 Nov 2023
- Primary completion30 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shang-Lin Chiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shang-Lin Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840873
- Sponsor's protocol ID
- c202305117
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06840873
- Acronym / sponsor ID
- c202305117
- Conditions
- Cardiorespiratory Fitness, Exercise, Long COVID, Nurses, Quality of Life (QOL), Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shang-Lin ChiangUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health consultation | Placebo comparator | Behavioral: Healthy consulationThe participants with healthy consultation do aerobic training at home |
| wearable device | Experimental | Device: wearable deviceThe participants with wearable device do exercise training at home |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable deviceParticipants 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. | Device | wearable device |
| Healthy consulationParticipants received routine outpatient health education. | Behavioural | Health consultation |
Primary outcome
Fatigue (score)
Time frame: 10 minutes
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.
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.
Aerobic capacity (VO2 max in ml/kg/min )
Time frame: 30 minutes
Maximal VO2 during testing, also means aerobic capacity
Working load in watt
Time frame: 30 minutes
Maximal Working load during testing
Heart rate recovery in beat/min
Time frame: 30 minutes
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.
Anaerobic threshold (AT in ml/kg/min)
Time frame: 30 minutes
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.
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.
2 secondary outcomes
Quality of life (scores)
Time frame: baseline, 4, and 8 weeks
Perceived stress (scores)
Time frame: baseline, 4, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable device and Healthy consulation in people with Cardiorespiratory Fitness and Exercise, run by Shang-Lin Chiang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (score) (time frame: 10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.