NCT06840873

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
Last Updated

October 7, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

February 18, 2025

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    10 minutes

  • O2 pulse in ml/beat

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

    30 minutes

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

    Maximal VO2 during testing, also means aerobic capacity

    30 minutes

  • Working load in watt

    Maximal Working load during testing

    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.

    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.

    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.

    10 minutes

Secondary Outcomes (2)

  • Quality of life (scores)

    baseline, 4, and 8 weeks

  • Perceived stress (scores)

    baseline, 4, and 8 weeks

Study Arms (2)

Health consultation

PLACEBO COMPARATOR

The participants with healthy consultation do aerobic training at home

Behavioral: Healthy consulation

wearable device

EXPERIMENTAL

The participants with wearable device do exercise training at home

Device: wearable device

Interventions

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.

wearable device

Participants received routine outpatient health education.

Health consultation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service General Hospital

Tiapei, 114, Taiwan

Location

MeSH Terms

Conditions

Motor ActivityPost-Acute COVID-19 SyndromeFatigue

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

BehaviorCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

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

February 18, 2025

First Posted

February 21, 2025

Study Start

November 2, 2023

Primary Completion

June 30, 2024

Study Completion

November 1, 2024

Last Updated

October 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations