Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial

NCT05725538 | Unknown

• 1 other identifier: COVIDReApp
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Post-Acute COVID19 Syndrome; Long COVID; Post COVID-19 Condition

Keywords

smartphone; mHealth; mobile health; telerehabilitation; exercise; Post-Acute COVID-19 Syndrome; Long COVID; Post-COVID Condition; COVIDReApp

Outcome Measures

Primary Outcomes (3)

• 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").

  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.

  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.

  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))

  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)

  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)

  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))

  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)

  Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.

Study Arms (2)

COVIDReApp Group

EXPERIMENTAL

The intervention group will complete a program of exercise guided by a m-health system (COVIDReApp) for 24 weeks.

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.

Other: Control Group

Interventions

COVIDReApp Group DEVICE

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.

COVIDReApp Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Hospital Universitario Puerta del Mar

Cadiz, 1009, Spain

RECRUITING

Related Publications (12)

• 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.

  PMID: 34951953 BACKGROUND

• 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.

  PMID: 34373540 BACKGROUND

• 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.

  PMID: 32644129 BACKGROUND

• 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.

  PMID: 33490928 BACKGROUND

• 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.

  PMID: 33711279 BACKGROUND

• 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.

  PMID: 34030861 BACKGROUND

• 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.

  PMID: 32667150 BACKGROUND

• 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.

  PMID: 34039689 BACKGROUND

• 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.

  PMID: 34386155 BACKGROUND

• 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.

  PMID: 34580067 BACKGROUND

• 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.

  PMID: 32926160 BACKGROUND

• 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.

  PMID: 39493634 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Jose A. Moral-Munoz, PhD

CONTACT

956 015699; joseantonio.moral@uca.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single-blind method will be carried out on the persons collecting and analysing the data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 13, 2023
• Study Start: March 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: September 15, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)