Post-Acute COVID19 SyndromeCOVIDReAppNCT05725538
Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial
A study testing COVIDReApp Group in people with Post-Acute COVID19 Syndrome and Long COVID, run by University of Cadiz at 1 site in Spain.
Trial summary
Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID19 Syndrome, Long COVID, Post COVID-19 Condition
- What is being tested?
- COVIDReApp Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2023to 15 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients.
- Over 18 years of age.
- Absence of cognitive and physical deficits that would preclude physical exercise.
- Owner of a smartphone with Internet access.
- Ability to understand and write in Spanish.
Who cannot join
- Concomitant diseases that prevent physical exercise.
- Contraindications to physical exercise detected by physicians.
- Participation in moderate-intensity activities (more than 30 minutes and 3 times per week) at the time of study initiation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, 1009
María José Soto Cárdenas, PhD
About this study
Official title: Efficacy of Exercise-based mHealth Intervention for Patients With Post-acute COVID-19 Syndrome Based on Fatigue, Fitness, Post-exertional Dyspnea, Pain, Anxiety, Depression, Cognitive Function, and Quality of Life: a Randomized Clinical Trial.
Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.
Our hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.
The achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.
- Being tested
- COVIDReApp Group, Control Group
- Keywords
- smartphone, mHealth, mobile health, telerehabilitation, exercise, Post-Acute COVID-19 Syndrome, Long COVID, Post-COVID Condition, COVIDReApp
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIDReApp GroupDevice
The COVIDReApp group will be required to complete an exercise program guided by an m-health system for three times per week during 24 weeks. A 60-minute program, following the recommendations of the American College of Sports Medicine. The daily session will be divided into:
- Warm-up: 5 min. walking so that the patient can hold a conversation , monopodial balance exercise, core exercise and other respiratory and joint mobility exercises.
- Aerobic training: Walking for 10 to 20 min. so that the patient can maintain a conversation, but having to stop to breathe from time to time.
- Strengthening: It will focus on 7 exercises. a) squats, b) dead weight with stiff legs, c) lateral pull-ups, d) inverted flies, e) flies, f) unilateral rowing and g) lateral raises.
- Cool down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back.
Control GroupOther
Participants will receive the same intervention in the traditional way, they will receive the exercise program in paper format. They will receive a document with photos and descriptions of the exercises to be performed. Their doctors will determine if the patients will be able to exercise regularly and they will perform them for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| COVIDReApp Group | Experimental | The intervention group will complete a program of exercise guided by a m-health system (COVIDReApp) for 24 weeks. Receives: Device: COVIDReApp Group |
| Control Group | Active comparator | The comparator group will complete a program of exercise in a traditional way (exercises will be provided in paper format) for 24 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))
The FSS consists of 9 items related to the interference of fatigue with specific activities and rates the perceived severity of fatigue on a 7-point scale (1 = "strongly disagree"; 7 = "strongly agree").
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)
Post-exertional dyspnea is assessed using the Dyspnea-12, a short questionnaire that takes into account both sensory and affective factors that may play a role in dyspnea. Each item in the questionnaire is scored from 0, if the symptom is mild, to 3, if it is severe, and the total score is the sum of the scores for all items. Six of the questions relate to sensory aspects and 6 to affective aspects of dyspnea. The total score ranges from 0 to 36, with 36 being the highest possible severity and 0 being the lowest.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)
The Short Form-12 (SF-12v2) will be administered to assess quality of life. This instrument contains 12 items that allow us to calculate the profile of 8 dimensions: (physical functioning, role-physical, bodily pain, general health perception, vitality, social functioning, role-emotional, and mental health) and two global scores: the physical health (PCS-12) and the mental health (MCS-12) component summary. Each global score ranges from 0 to 100, with higher scores indicating better health.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Secondary outcomes (10)
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))
VAS is a scale used to rate the patient's pain intensity. The patient chooses a number from 0 to 10 (11-point numeric scale) that represents the best level of pain that the patient can imagine. A score of 0 represents no pain and 10 represents the worst pain imaginable.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)
The Arm Curl Test assesses upper body strength by determining the number of times a hand weight (2.3 kg) can be curled through a full range of motion in 30 seconds.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)
The chair stand test evaluates lower body muscular strength by counting the number of times a person can go from a sitting position to a standing position in 30 seconds.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))
The two-minute walk test (2MWT) assesses walking ability, functional endurance and functional capacity. It consists of measuring the distance the patient can walk for 2 minutes as fast as he or she can safely without assistance.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)
Depression and anxiety are assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D).
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))
The Test Your Memory (TYM) screening test is used to assess cognitive function. This tool consists of 10 items with a total score ranging from 0 to 50, calculated on 10 cognitive dimensions: executive function, anterograde memory, visuospatial ability, naming, similarities, verbal fluency, calculation, retrograde memory, copying, orientation. The cut-off point is 42/50 (≤41 points indicates cognitive dysfunction) and a higher score indicates better cognitive performance.
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index
Body measurements: height (standard height meter), weight, and body mass index (Tanita Model TBF-310 GS Weight Scale, Tanita Corporation of America, Inc., Arlington Heights, IL).
Measured: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Baseline of sociodemographic variables
A structured questionnaire will be used to collect sociodemographic data, including the following variables: gender, age, socioeconomic status, marital status, education level, employment status, clinical data, and use of alternative therapies.
Measured: Baseline.
Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))
CovidReApp system will register the daily exercise, which allows us to know the exercise difficulty of each exercise.
Measured: Only CovidReApp group: Daily.
Daily registry of the adherence (CovidReApp log registration and self-reported)
The information is collected by the system only in the COVIDReApp group.
Measured: Daily.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Mar 2023 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID19 SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose A. Moral-Munoz, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725538
- Sponsor's protocol ID
- COVIDReApp
- Acronym
- COVIDReApp
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with third parties.
Publications
Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
PubMed 34951953Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 long-term effects of COVID-19: a systematic review and meta-analysis. Sci Rep. 2021 Aug 9;11(1):16144. doi: 10.1038/s41598-021-95565-8.
PubMed 34373540Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Raman B, Cassar MP, Tunnicliffe EM, Filippini N, Griffanti L, Alfaro-Almagro F, Okell T, Sheerin F, Xie C, Mahmod M, Mozes FE, Lewandowski AJ, Ohuma EO, Holdsworth D, Lamlum H, Woodman MJ, Krasopoulos C, Mills R, McConnell FAK, Wang C, Arthofer C, Lange FJ, Andersson J, Jenkinson M, Antoniades C, Channon KM, Shanmuganathan M, Ferreira VM, Piechnik SK, Klenerman P, Brightling C, Talbot NP, Petousi N, Rahman NM, Ho LP, Saunders K, Geddes JR, Harrison PJ, Pattinson K, Rowland MJ, Angus BJ, Gleeson F, Pavlides M, Koychev I, Miller KL, Mackay C, Jezzard P, Smith SM, Neubauer S. Medium-term effects of SARS-CoV-2 infection on multiple vital organs, exercise capacity, cognition, quality of life and mental health, post-hospital discharge. EClinicalMedicine. 2021 Jan 7;31:100683. doi: 10.1016/j.eclinm.2020.100683. eCollection 2021 Jan.
PubMed 33490928Leite VF, Rampim DB, Jorge VC, de Lima MDCC, Cezarino LG, da Rocha CN, Esper RB; Prevent Senior COVID-19 Rehabilitation Study. Persistent Symptoms and Disability After COVID-19 Hospitalization: Data From a Comprehensive Telerehabilitation Program. Arch Phys Med Rehabil. 2021 Jul;102(7):1308-1316. doi: 10.1016/j.apmr.2021.03.001. Epub 2021 Mar 10.
PubMed 33711279Ausin-Garcia C, Cervilla-Munoz E, Millan-Nunez-Cortes J. Long-term consequences of SARS-COV2 infection: Long-Covid patterns and possible public health implications. Med Clin (Barc). 2021 Oct 8;157(7):e293-e294. doi: 10.1016/j.medcli.2021.02.022. Epub 2021 May 6. No abstract available.
PubMed 34030861Curci C, Pisano F, Bonacci E, Camozzi DM, Ceravolo C, Bergonzi R, De Franceschi S, Moro P, Guarnieri R, Ferrillo M, Negrini F, de Sire A. Early rehabilitation in post-acute COVID-19 patients: data from an Italian COVID-19 Rehabilitation Unit and proposal of a treatment protocol. Eur J Phys Rehabil Med. 2020 Oct;56(5):633-641. doi: 10.23736/S1973-9087.20.06339-X. Epub 2020 Jul 15.
PubMed 32667150O'Sullivan O, Barker-Davies RM, Thompson K, Bahadur S, Gough M, Lewis S, Martin M, Segalini A, Wallace G, Phillip R, Cranley M. Rehabilitation post-COVID-19: cross-sectional observations using the Stanford Hall remote assessment tool. BMJ Mil Health. 2023 Jun;169(3):243-248. doi: 10.1136/bmjmilitary-2021-001856. Epub 2021 May 26.
PubMed 34039689Patel J, Franklin BA, Pujary D, Kaur G, Deodhar A, Kharbanda S, Contractor A. Effects of Supervised Exercise-Based Telerehabilitation on Walk Test Performance and Quality of Life in Patients in India With Chronic Disease: Combatting Covid-19. Int J Telerehabil. 2021 Jun 22;13(1):e6349. doi: 10.5195/ijt.2021.6349. eCollection 2021.
PubMed 34386155Puterman E, Hives B, Mazara N, Grishin N, Webster J, Hutton S, Koehle MS, Liu Y, Beauchamp MR. COVID-19 Pandemic and Exercise (COPE) trial: a multigroup pragmatic randomised controlled trial examining effects of app-based at-home exercise programs on depressive symptoms. Br J Sports Med. 2022 May;56(10):546-552. doi: 10.1136/bjsports-2021-104379. Epub 2021 Sep 27.
PubMed 34580067Yang Y, Koenigstorfer J. Determinants of physical activity maintenance during the Covid-19 pandemic: a focus on fitness apps. Transl Behav Med. 2020 Oct 8;10(4):835-842. doi: 10.1093/tbm/ibaa086.
PubMed 32926160Salvador-Ruiz AJ, Moral-Munoz JA, Salazar A, Lucena-Anton D, De Sola H, Failde I, Duenas M. Enhancing exercise intervention for patients with post-acute COVID-19 syndrome using mobile health technology: The COVIDReApp randomised controlled trial protocol. Digit Health. 2024 Oct 29;10:20552076241247936. doi: 10.1177/20552076241247936. eCollection 2024 Jan-Dec.
PubMed 39493634
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exercise-based mHealth Intervention for Patients With Post-acute COVID-19 Syndrome Based on Fatigue, Fitness, Post-exertional Dyspnea, Pain, Anxiety, Depression, Cognitive Function, and Quality of Life: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05725538
- Acronym / sponsor ID
- COVIDReApp / COVIDReApp
- Keywords
- smartphone, mHealth, mobile health, telerehabilitation, exercise, Post-Acute COVID-19 Syndrome, Long COVID, Post-COVID Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.
Our hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.
The achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVIDReApp Group | Experimental | Device: COVIDReApp GroupThe intervention group will complete a program of exercise guided by a m-health system (COVIDReApp) for 24 weeks. |
| Control Group | Active comparator | Other: Control GroupThe comparator group will complete a program of exercise in a traditional way (exercises will be provided in paper format) for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients.
- Over 18 years of age.
- Absence of cognitive and physical deficits that would preclude physical exercise.
- Owner of a smartphone with Internet access.
- Ability to understand and write in Spanish.
Key exclusion criteria (3 listed)
- Concomitant diseases that prevent physical exercise.
- Contraindications to physical exercise detected by physicians.
- Participation in moderate-intensity activities (more than 30 minutes and 3 times per week) at the time of study initiation.
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 |
|---|---|---|
| COVIDReApp GroupThe COVIDReApp group will be required to complete an exercise program guided by an m-health system for three times per week during 24 weeks. A 60-minute program, following the recommendations of the American College of Sports Medicine. The daily session will be divided into: * Warm-up: 5 min. walking so that the patient can hold a conversation , monopodial balance exercise, core exercise and other respiratory and joint mobility exercises. * Aerobic training: Walking for 10 to 20 min. so that the patient can maintain a conversation, but having to stop to breathe from time to time. * Strengthening: It will focus on 7 exercises. a) squats, b) dead weight with stiff legs, c) lateral pull-ups, d) inverted flies, e) flies, f) unilateral rowing and g) lateral raises. * Cool down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back. | Device | COVIDReApp Group |
| Control GroupParticipants will receive the same intervention in the traditional way, they will receive the exercise program in paper format. They will receive a document with photos and descriptions of the exercises to be performed. Their doctors will determine if the patients will be able to exercise regularly and they will perform them for 24 weeks. | Other | Control Group |
Primary outcome
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
The FSS consists of 9 items related to the interference of fatigue with specific activities and rates the perceived severity of fatigue on a 7-point scale (1 = "strongly disagree"; 7 = "strongly agree").
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Post-exertional dyspnea is assessed using the Dyspnea-12, a short questionnaire that takes into account both sensory and affective factors that may play a role in dyspnea. Each item in the questionnaire is scored from 0, if the symptom is mild, to 3, if it is severe, and the total score is the sum of the scores for all items. Six of the questions relate to sensory aspects and 6 to affective aspects of dyspnea. The total score ranges from 0 to 36, with 36 being the highest possible severity and 0 being the lowest.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
The Short Form-12 (SF-12v2) will be administered to assess quality of life. This instrument contains 12 items that allow us to calculate the profile of 8 dimensions: (physical functioning, role-physical, bodily pain, general health perception, vitality, social functioning, role-emotional, and mental health) and two global scores: the physical health (PCS-12) and the mental health (MCS-12) component summary. Each global score ranges from 0 to 100, with higher scores indicating better health.
10 secondary outcomes
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index
Time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Baseline of sociodemographic variables
Time frame: Baseline.
Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))
Time frame: Only CovidReApp group: Daily.
Daily registry of the adherence (CovidReApp log registration and self-reported)
Time frame: Daily.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 34951953Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
- Background: PubMed 34373540Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 long-term effects of COVID-19: a systematic review and meta-analysis. Sci Rep. 2021 Aug 9;11(1):16144. doi: 10.1038/s41598-021-95565-8.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 33490928Raman B, Cassar MP, Tunnicliffe EM, Filippini N, Griffanti L, Alfaro-Almagro F, Okell T, Sheerin F, Xie C, Mahmod M, Mozes FE, Lewandowski AJ, Ohuma EO, Holdsworth D, Lamlum H, Woodman MJ, Krasopoulos C, Mills R, McConnell FAK, Wang C, Arthofer C, Lange FJ, Andersson J, Jenkinson M, Antoniades C, Channon KM, Shanmuganathan M, Ferreira VM, Piechnik SK, Klenerman P, Brightling C, Talbot NP, Petousi N, Rahman NM, Ho LP, Saunders K, Geddes JR, Harrison PJ, Pattinson K, Rowland MJ, Angus BJ, Gleeson F, Pavlides M, Koychev I, Miller KL, Mackay C, Jezzard P, Smith SM, Neubauer S. Medium-term effects of SARS-CoV-2 infection on multiple vital organs, exercise capacity, cognition, quality of life and mental health, post-hospital discharge. EClinicalMedicine. 2021 Jan 7;31:100683. doi: 10.1016/j.eclinm.2020.100683. eCollection 2021 Jan.
- Background: PubMed 33711279Leite VF, Rampim DB, Jorge VC, de Lima MDCC, Cezarino LG, da Rocha CN, Esper RB; Prevent Senior COVID-19 Rehabilitation Study. Persistent Symptoms and Disability After COVID-19 Hospitalization: Data From a Comprehensive Telerehabilitation Program. Arch Phys Med Rehabil. 2021 Jul;102(7):1308-1316. doi: 10.1016/j.apmr.2021.03.001. Epub 2021 Mar 10.
- Background: PubMed 34030861Ausin-Garcia C, Cervilla-Munoz E, Millan-Nunez-Cortes J. Long-term consequences of SARS-COV2 infection: Long-Covid patterns and possible public health implications. Med Clin (Barc). 2021 Oct 8;157(7):e293-e294. doi: 10.1016/j.medcli.2021.02.022. Epub 2021 May 6. No abstract available.
- Background: PubMed 32667150Curci C, Pisano F, Bonacci E, Camozzi DM, Ceravolo C, Bergonzi R, De Franceschi S, Moro P, Guarnieri R, Ferrillo M, Negrini F, de Sire A. Early rehabilitation in post-acute COVID-19 patients: data from an Italian COVID-19 Rehabilitation Unit and proposal of a treatment protocol. Eur J Phys Rehabil Med. 2020 Oct;56(5):633-641. doi: 10.23736/S1973-9087.20.06339-X. Epub 2020 Jul 15.
- Background: PubMed 34039689O'Sullivan O, Barker-Davies RM, Thompson K, Bahadur S, Gough M, Lewis S, Martin M, Segalini A, Wallace G, Phillip R, Cranley M. Rehabilitation post-COVID-19: cross-sectional observations using the Stanford Hall remote assessment tool. BMJ Mil Health. 2023 Jun;169(3):243-248. doi: 10.1136/bmjmilitary-2021-001856. Epub 2021 May 26.
- Background: PubMed 34386155Patel J, Franklin BA, Pujary D, Kaur G, Deodhar A, Kharbanda S, Contractor A. Effects of Supervised Exercise-Based Telerehabilitation on Walk Test Performance and Quality of Life in Patients in India With Chronic Disease: Combatting Covid-19. Int J Telerehabil. 2021 Jun 22;13(1):e6349. doi: 10.5195/ijt.2021.6349. eCollection 2021.
- Background: PubMed 34580067Puterman E, Hives B, Mazara N, Grishin N, Webster J, Hutton S, Koehle MS, Liu Y, Beauchamp MR. COVID-19 Pandemic and Exercise (COPE) trial: a multigroup pragmatic randomised controlled trial examining effects of app-based at-home exercise programs on depressive symptoms. Br J Sports Med. 2022 May;56(10):546-552. doi: 10.1136/bjsports-2021-104379. Epub 2021 Sep 27.
- Background: PubMed 32926160Yang Y, Koenigstorfer J. Determinants of physical activity maintenance during the Covid-19 pandemic: a focus on fitness apps. Transl Behav Med. 2020 Oct 8;10(4):835-842. doi: 10.1093/tbm/ibaa086.
- Derived from this study: PubMed 39493634Salvador-Ruiz AJ, Moral-Munoz JA, Salazar A, Lucena-Anton D, De Sola H, Failde I, Duenas M. Enhancing exercise intervention for patients with post-acute COVID-19 syndrome using mobile health technology: The COVIDReApp randomised controlled trial protocol. Digit Health. 2024 Oct 29;10:20552076241247936. doi: 10.1177/20552076241247936. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No. Individual data will not be shared with third parties.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVIDReApp Group in people with Post-Acute COVID19 Syndrome and Long COVID, run by University of Cadiz at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose A. Moral-Munoz, PhD (956 015699 ext. +34, joseantonio.moral@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS)) (time frame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.). The study lists 3 primary outcomes in all. 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 NCT05725538, which also lists 12 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 13 Feb 2023.