CoronavirusNCT04794036
Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient
A study testing Asynchronous telerehabilitation programme and Rehabilitation programme in people with Coronavirus and Fatigue, run by Universidad San Jorge at 2 sites in Spain.
Trial summary
SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus, Fatigue, Musculoskeletal Complication
- What is being tested?
- Asynchronous telerehabilitation programme and Rehabilitation programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Apr 2021to 1 Dec 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18-75 years.
- Patients who have been hospitalized for more than 5 days for COVID-19.
- Patients who have been discharged from the hospital and present a fatigue score higher than 4 points on average on the fatigue severity scale (FSS).
- Independent walking, even with the use of any technical aid.
- Have signed the informed consent form.
Who cannot join
- Patients with central and/or peripheral neurological diseases that prevent the programme from being followed.
- Patients with rheumatic pathology or acute musculoskeletal injury in their medical history.
- Patients with severe respiratory failure: SaO2 less than 90% or respiratory rate >30.
- Patients with cardiac comorbidities or signs of cardiovascular inestability as uncontrolled arrythmia, blood pressure and/or effort angina.
- Patients with other contraindicated pathology for moderate-intensity aerobic or strength exercise.
- Patients without access to mobile internet or computer with internet at home.
- Patients with a score ≤24 on the Mini-Cognitive Examination (MEC).
- Patients who are unable to follow oral and written instructions in Spanish.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Real Nuestra Señora de Gracia
Zaragoza, 50004
Hospital Royo Villanova
Zaragoza, 50007
About this study
Official title: Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patients: a Feasibility Study
SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is recommended that early post-acute rehabilitation be continued after the hospital phase to increase levels of physical activity, which can also be continued with long-term telerehabilitation.
This project would offer a free service of asynchronous physical telerehabilitation for the patient that is easy to implement and follow up.
Read more
For this purpose, patients will be recruited at the time of discharge from the Hospital Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza and two intervention groups with the same physical therapy and educational programme will be carried out. The experimental group will be carried out by means of home telerehabilitation, while the control group will receive the programme in an explanatory booklet.
The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week physical therapy and therapeutic education programme using asynchronous telerehabilitation in post-COVID-19 patients, and to compare its effects with patients who have undergone the same programme, but in a non-telematic format.
The secondary objective is to analyze the feasibility of a physical home-based asynchronous telerehabilitation programme in post-COVID-19 patients.
Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic education using asynchronous telerehabilitation software is feasible and preliminarily effective in increasing physical fitness as well as adherence to treatment, and in the improvement of psychosocial factors.
Read the detailed description
At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge.
At the second phase, a feasibility pilot study with a single-blinded randomized clinical trial design with volunteer patients admitted to hospital and recruited at the time of discharge by COVID-19 will evaluate a physiotherapy programme. There will be an intervention group (asynchronous telerehabilitation at home) and a control group (home rehabilitation by means of an explanatory leaflet). The intervention will be carried out for 12 weeks with a follow-up at 3 and 6 months.
Intervention:
The physical rehabilitation programme will be designed with three levels of intensity of aerobic, strength and respiratory exercises, and a list of recommendations for self-management of the sequelae of the COVID-19.
The intervention will last for a total of 12 weeks at home (three days a week for 45-60 minutes a day) with a biweekly phone check-up.
All patients will be provided with the same physical rehabilitation and educational programme, with each allocation group differing in the format of the prescription.
Experimental group
A programme with exercise videos and health recommendations will be prescribed through a telerehabilitation platform to improve fatigue and fitness resulting from COVID-19. The application will be installed on patients' mobile phones and its use will be explained to them so that they can carry out the programme from their homes.
Control group The control group will receive a paper booklet with clear pictures and descriptions of the exercise and educative programme to improve fatigue and fitness.
Assessment:
Fatigue will be assessed with the fatigue severity scale (FSS). Functional capacity will be measured through operation: with the Post-COVID Functional Status Scale (PCFS), the strength with the 30" sit-to-stand (STST), the 30" arm curl test (ACT), and through aerobic capacity with de six minutes walking test (6MWT).
Psychosocial factors will be measured with the general self-efficacy scale (GSES), the depression and anxiety scale (DASS-21), the behavioral regulation questionnaire in sport (BRSQ) and the multidimensional scale of perceived social support (MSPSS).
Quality of life will be measured with the quality of life scale (SF-12).
Adherence and engagement be measured by diary recording and satisfaction with a brief interview.
Outcome measures:
Fatigue, functional status post-COVID-19, strength, aerobic capacity, anxiety and depression, behavior in sport, perceived social support and quality of life will be evaluated before intervention, after intervention (12 weeks) at 3 and 6 months for follow-up.
Adherence and satisfaction will be evaluated after intervention (12 weeks) and during intervention (each 15 days).
- Conditions
- Coronavirus, Fatigue, Musculoskeletal Complication
- Being tested
- Asynchronous telerehabilitation programme, Rehabilitation programme
- Keywords
- Coronavirus, Telerehabilitation, Exercise Therapy, Education
- Medical subject headings
- Coronavirus Infections, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronous telerehabilitation programmeOther
Home-based physical rehabilitation programme using a telerehabilitation platform
Rehabilitation programmeOther
Home-based physical rehabilitation programme by means of an explanatory booklet
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Telerehabilitation asynchronous programme at home Receives: Other: Asynchronous telerehabilitation programme |
| Control Group | Active comparator | Rehabilitation programme with an explanatory booklet at home Receives: Other: Rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Level
Change in fatigue severity level. Fatigue will be assessed with the Fatigue Severity Scale (FSS). The Fatigue Severity Scale is a self-reported scale composed of 9 items. Each item is rated from 1 to 7 (from 1=strongly disagree to 7=strongly agree). In the FSS, a mean of less than 4 points is considered to be no fatigue and more than 4 is considered to present fatigue. The higher the score, the greater the severity of fatigue.
Measured: Pre-intervention (day 1); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Secondary outcomes (13)
Adherence
Adherence level. Adherence will be measured in days of exercise performance by means of a diary questionnaire. Adherence will be coded 0=if on that day they have not done what was prescribed, 1= if they have done some exercise, 2=if on that day they have carried out all the activity prescribed, 3= if they have carried out additional activity.
Measured: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Engagement
Engagement level. Engagement will be measured in days of exercise performance by means of a diary questionnaire. Engagement will be coded 0=if on that day they have not done what was prescribed, 1= if they have done some exercise, 2=if on that day they have carried out all the activity prescribed, 3= if they have carried out additional activity.
Measured: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Satisfaction level
Satisfaction will be measured with a brief interview using a Likert scale. Satisfaction will be recorded on a Likert scale from 0=very dissatisfied to 4=very satisfied.
Measured: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Incidents
Incidents will be measured with a brief interview. The number of incidents and whether or not it has influenced adherence shall be recorded.
Measured: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Maximum Leg Strength Endurance
Maximum leg strength endurance for 30" will be measured with the strength with the 30" Sit-To-Stand (STST). To perform the 30" Sit-To-Stand, from a sitting position, patients will rise and return to the starting position as many times as possible within 30 seconds.
Measured: Pre-intervention (1 day); after intervention (day 84).
Maximum Arm Strength Endurance
Maximum arm strength endurance for 30" will be measured with the 30" Arm Curl Test (ACT). To perform the Arm Curl Test, from a sitting position, as many elbow flexion-extension movements of dominant limb as possible should be performed in 30 seconds with a 2 kg weight.
Measured: Pre-intervention (1 day); after intervention (day 84).
Submaximum Aerobic Capacity Walking
Submaximum aerobic capacity walking for 6 minutes will be measured with the 6-Minutes Walking Test (6MWT). In the 6-Minutes Walking Test, patients are asked to walk the maximum possible distance for 6 minutes.
Measured: Pre-intervention (1 day); after intervention (day 84).
Post-COVID Functional Status
Functional capacity will be measured with the Post-COVID Functional Status Scale (PCFS). In the Post-COVID Functional Status Scale, the levels range from 4 level that means severe functional limitations to 0 that means no limitations and no symptoms."D" level means death.
Measured: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention)
Depression, Anxiety and Stress
Depression, anxiety and stress will be measured with the Depression, Anxiety and Stress Scale (DASS-21). In this scale, each item is answered according to the intensity of each symptom suffered in the last week on a Likert scale from 0 to 3 points. The global scale contains three different blocks for: depression, anxiety and stress. Each block has seven items. The global scale score ranges from 0 to 21 points. In the Depression, Anxiety and Stress Scale, higher scores indicate higher levels of stress, depression and anxiety.
Measured: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Self-efficacy
Self-efficacy will be measured with the General Self-efficacy Scale (GSES).The General Self-efficacy Scale consists of 10 items with a minimum score of 10 points and a maximum of 50 points with Likert-type responses. In the GSES, the higher score indicates higher perceived general self-efficacy.
Measured: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Behavior in sport
Behavior in sport will be measured with the Behavioral Questionnaire in Sport (BRSQ) (36-item version). The Behavioral Questionnaire in Sport measures extrinsic motivation through different factors depending on whether the patient performs physical activity because they believe that it is part of a healthy lifestyle (integrated regulation), because they believe that the activity is important but not pleasant (identified regulation), because of feelings of guilt (introjected regulation) and / or external pressures (external regulation). Intrinsic motivation is measured by three factors, knowledge, execution, and stimulation. Another factor it measures is demotivation. This scale is validated in the Spanish context. Its items are valued using a Likert scale that ranges from 1 (not at all true) to 7 (very true).
Measured: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Perceived social support
Perceived social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS). The Multidimensional Scale of Perceived Social Support is validated in the Spanish population by Landeta and Calvete, obtaining high psychometric properties. It is considered a priority scale to be applied in people who are in the process of recovery. It measures social support in three dimensions (family, friends and significant others) and also provides a final score. The version used consists of 12 items that are answered using a Likert scale that ranges from 1 (totally disagree) to 7 (totally agree).
Measured: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Quality of Life Assessment
Changes in the quality of life. Quality of life will be measured with the Short Form Health Survey (SF-12-v2). It consists of 12 likert-type items ranging from 1 to 6 points. In the Short Form Health Survey, a higher score indicates a higher self-perceived quality of life.
Measured: pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start5 Apr 2021
- Primary completion13 Jun 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Real Nuestra Señora de Gracia, Hospital Universitario Royo Villanova
- Responsible party
- Sponsor
- Investigators
- Carolina Jiménez Sánchez, MD, Principal investigator, Universidad San JorgeSandra Calvo, Dr, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794036
- Sponsor's protocol ID
- COVID-19_TRHB
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carpallo-Porcar B, Calvo S, Perez-Palomares S, Blazquez-Perez L, Brandin-de la Cruz N, Jimenez-Sanchez C. Perceptions and Experiences of a Multimodal Rehabilitation Program for People With Post-Acute COVID-19: A Qualitative Study. Health Expect. 2025 Jun;28(3):e70283. doi: 10.1111/hex.70283.
PubMed 40302157Carpallo-Porcar B, Calvo S, Alamillo-Salas J, Herrero P, Gomez-Barrera M, Jimenez-Sanchez C. An Opportunity for Management of Fatigue, Physical Condition, and Quality of Life Through Asynchronous Telerehabilitation in Patients After Acute Coronavirus Disease 2019: A Randomized Controlled Pilot Study. Arch Phys Med Rehabil. 2024 Aug;105(8):1439-1448. doi: 10.1016/j.apmr.2024.04.014. Epub 2024 May 4.
PubMed 38710426Carpallo-Porcar B, Romo-Calvo L, Perez-Palomares S, Jimenez-Sanchez C, Herrero P, Brandin-de la Cruz N, Calvo S. Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial. PLoS One. 2022 Jul 19;17(7):e0270766. doi: 10.1371/journal.pone.0270766. eCollection 2022.
PubMed 35853037
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04794036
- Acronym / sponsor ID
- COVID-19_TRHB
- Conditions
- Coronavirus, Fatigue, Musculoskeletal Complication
- Keywords
- Coronavirus, Telerehabilitation, Exercise Therapy, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Hospital Real Nuestra Señora de Gracia, Hospital Universitario Royo Villanova
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Mar 2021 (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.
SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is recommended that early post-acute rehabilitation be continued after the hospital phase to increase levels of physical activity, which can also be continued with long-term telerehabilitation.
This project would offer a free service of asynchronous physical telerehabilitation for the patient that is easy to implement and follow up.
For this purpose, patients will be recruited at the time of discharge from the Hospital Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza and two intervention groups with the same physical therapy and educational programme will be carried out. The experimental group will be carried out by means of home telerehabilitation, while the control group will receive the programme in an explanatory booklet.
The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week physical therapy and therapeutic education programme using asynchronous telerehabilitation in post-COVID-19 patients, and to compare its effects with patients who have undergone the same programme, but in a non-telematic format.
The secondary objective is to analyze the feasibility of a physical home-based asynchronous telerehabilitation programme in post-COVID-19 patients.
Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic education using asynchronous telerehabilitation software is feasible and preliminarily effective in increasing physical fitness as well as adherence to treatment, and in the improvement of psychosocial factors.
Detailed description
At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge.
At the second phase, a feasibility pilot study with a single-blinded randomized clinical trial design with volunteer patients admitted to hospital and recruited at the time of discharge by COVID-19 will evaluate a physiotherapy programme. There will be an intervention group (asynchronous telerehabilitation at home) and a control group (home rehabilitation by means of an explanatory leaflet). The intervention will be carried out for 12 weeks with a follow-up at 3 and 6 months.
Intervention:
The physical rehabilitation programme will be designed with three levels of intensity of aerobic, strength and respiratory exercises, and a list of recommendations for self-management of the sequelae of the COVID-19.
The intervention will last for a total of 12 weeks at home (three days a week for 45-60 minutes a day) with a biweekly phone check-up.
All patients will be provided with the same physical rehabilitation and educational programme, with each allocation group differing in the format of the prescription.
Experimental group
A programme with exercise videos and health recommendations will be prescribed through a telerehabilitation platform to improve fatigue and fitness resulting from COVID-19. The application will be installed on patients' mobile phones and its use will be explained to them so that they can carry out the programme from their homes.
Control group The control group will receive a paper booklet with clear pictures and descriptions of the exercise and educative programme to improve fatigue and fitness.
Assessment:
Fatigue will be assessed with the fatigue severity scale (FSS). Functional capacity will be measured through operation: with the Post-COVID Functional Status Scale (PCFS), the strength with the 30" sit-to-stand (STST), the 30" arm curl test (ACT), and through aerobic capacity with de six minutes walking test (6MWT).
Psychosocial factors will be measured with the general self-efficacy scale (GSES), the depression and anxiety scale (DASS-21), the behavioral regulation questionnaire in sport (BRSQ) and the multidimensional scale of perceived social support (MSPSS).
Quality of life will be measured with the quality of life scale (SF-12).
Adherence and engagement be measured by diary recording and satisfaction with a brief interview.
Outcome measures:
Fatigue, functional status post-COVID-19, strength, aerobic capacity, anxiety and depression, behavior in sport, perceived social support and quality of life will be evaluated before intervention, after intervention (12 weeks) at 3 and 6 months for follow-up.
Adherence and satisfaction will be evaluated after intervention (12 weeks) and during intervention (each 15 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Asynchronous telerehabilitation programmeTelerehabilitation asynchronous programme at home |
| Control Group | Active comparator | Other: Rehabilitation programmeRehabilitation programme with an explanatory booklet at home |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range 18-75 years.
- Patients who have been hospitalized for more than 5 days for COVID-19.
- Patients who have been discharged from the hospital and present a fatigue score higher than 4 points on average on the fatigue severity scale (FSS).
- Independent walking, even with the use of any technical aid.
- Have signed the informed consent form.
Key exclusion criteria (8 listed)
- Patients with central and/or peripheral neurological diseases that prevent the programme from being followed.
- Patients with rheumatic pathology or acute musculoskeletal injury in their medical history.
- Patients with severe respiratory failure: SaO2 less than 90% or respiratory rate >30.
- Patients with cardiac comorbidities or signs of cardiovascular inestability as uncontrolled arrythmia, blood pressure and/or effort angina.
- Patients with other contraindicated pathology for moderate-intensity aerobic or strength exercise.
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 |
|---|---|---|
| Asynchronous telerehabilitation programmeHome-based physical rehabilitation programme using a telerehabilitation platform | Other | Experimental Group |
| Rehabilitation programmeHome-based physical rehabilitation programme by means of an explanatory booklet | Other | Control Group |
Primary outcome
Fatigue Severity Level
Time frame: Pre-intervention (day 1); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Change in fatigue severity level. Fatigue will be assessed with the Fatigue Severity Scale (FSS). The Fatigue Severity Scale is a self-reported scale composed of 9 items. Each item is rated from 1 to 7 (from 1=strongly disagree to 7=strongly agree). In the FSS, a mean of less than 4 points is considered to be no fatigue and more than 4 is considered to present fatigue. The higher the score, the greater the severity of fatigue.
13 secondary outcomes
Adherence
Time frame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Engagement
Time frame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Satisfaction level
Time frame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Incidents
Time frame: Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).
Maximum Leg Strength Endurance
Time frame: Pre-intervention (1 day); after intervention (day 84).
Maximum Arm Strength Endurance
Time frame: Pre-intervention (1 day); after intervention (day 84).
Submaximum Aerobic Capacity Walking
Time frame: Pre-intervention (1 day); after intervention (day 84).
Post-COVID Functional Status
Time frame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention)
Depression, Anxiety and Stress
Time frame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Self-efficacy
Time frame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Behavior in sport
Time frame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Perceived social support
Time frame: Pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
Quality of Life Assessment
Time frame: pre-intervention (1 day); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).
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 11 Apr 2023.
- Derived from this study: PubMed 40302157Carpallo-Porcar B, Calvo S, Perez-Palomares S, Blazquez-Perez L, Brandin-de la Cruz N, Jimenez-Sanchez C. Perceptions and Experiences of a Multimodal Rehabilitation Program for People With Post-Acute COVID-19: A Qualitative Study. Health Expect. 2025 Jun;28(3):e70283. doi: 10.1111/hex.70283.
- Derived from this study: PubMed 38710426Carpallo-Porcar B, Calvo S, Alamillo-Salas J, Herrero P, Gomez-Barrera M, Jimenez-Sanchez C. An Opportunity for Management of Fatigue, Physical Condition, and Quality of Life Through Asynchronous Telerehabilitation in Patients After Acute Coronavirus Disease 2019: A Randomized Controlled Pilot Study. Arch Phys Med Rehabil. 2024 Aug;105(8):1439-1448. doi: 10.1016/j.apmr.2024.04.014. Epub 2024 May 4.
- Derived from this study: PubMed 35853037Carpallo-Porcar B, Romo-Calvo L, Perez-Palomares S, Jimenez-Sanchez C, Herrero P, Brandin-de la Cruz N, Calvo S. Efficacy of an asynchronous telerehabilitation program in post-COVID-19 patients: A protocol for a pilot randomized controlled trial. PLoS One. 2022 Jul 19;17(7):e0270766. doi: 10.1371/journal.pone.0270766. eCollection 2022.
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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.
Carolina Jiménez Sánchez, MD principal investigator
Universidad San Jorge
Sandra Calvo, Dr principal investigator
Universidad San Jorge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asynchronous telerehabilitation programme and Rehabilitation programme in people with Coronavirus and Fatigue, run by Universidad San Jorge at 2 sites in Spain.
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 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. 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 Severity Level (time frame: Pre-intervention (day 1); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794036, which also lists 3 linked publications.
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 11 Apr 2023.