Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial
NCT ID: NCT05725538
Last Updated: 2023-02-13
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-03-15
2024-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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COVIDReApp Group
The intervention group will complete a program of exercise guided by a m-health system (COVIDReApp) for 24 weeks.
COVIDReApp Group
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 Group
The comparator group will complete a program of exercise in a traditional way (exercises will be provided in paper format) for 24 weeks.
Control Group
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.
Interventions
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COVIDReApp Group
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 Group
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Cadiz
OTHER
Responsible Party
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Jose A. Moral-Munoz
Assistant Professor
Locations
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Hospital Universitario Puerta del Mar
Cadiz, , Spain
Countries
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Central Contacts
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Facility Contacts
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María José Soto Cárdenas, PhD
Role: primary
References
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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.
Lopez-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.
Carfi 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.
Raman 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.
Leite 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.
Ausin-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.
Curci 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.
O'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.
Patel 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.
Puterman 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.
Yang 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.
Salvador-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.
Other Identifiers
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COVIDReApp
Identifier Type: -
Identifier Source: org_study_id
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