Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient

NCT04794036 | Completed DMC

• 1 other identifier: COVID-19_TRHB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Coronavirus; Fatigue; Musculoskeletal Complication

Keywords

Coronavirus; Telerehabilitation; Exercise Therapy; Education

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).

• Engagement

  Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).

• Satisfaction level

  Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).

• Incidents

  Pre-intervention (day 1); during intervention (every 15 days during intervention); after intervention (day 84).

• Maximum Leg Strength Endurance

  Pre-intervention (1 day); after intervention (day 84).

Study Arms (2)

Experimental Group

EXPERIMENTAL

Telerehabilitation asynchronous programme at home

Other: Asynchronous telerehabilitation programme

Control Group

ACTIVE COMPARATOR

Rehabilitation programme with an explanatory booklet at home

Other: Rehabilitation programme

Interventions

Asynchronous telerehabilitation programme OTHER

Home-based physical rehabilitation programme using a telerehabilitation platform

Experimental Group

Rehabilitation programme OTHER

Home-based physical rehabilitation programme by means of an explanatory booklet

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Jorge: lead
• Hospital Real Nuestra Señora de Gracia: collaborator
• Hospital Royo Villanova: collaborator

Study Sites (2)

Hospital Real Nuestra Señora de Gracia

Zaragoza, 50004, Spain

Location

Hospital Royo Villanova

Zaragoza, 50007, Spain

Location

Related Publications (3)

• 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.

  PMID: 40302157 DERIVED

• Carpallo-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.

  PMID: 38710426 DERIVED

• Carpallo-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.

  PMID: 35853037 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Fatigue

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Jiménez Sánchez, MD

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

• Sandra Calvo, Dr

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 11, 2021
• Study Start: April 5, 2021
• Primary Completion: June 13, 2022
• Study Completion: December 1, 2022
• Last Updated: April 11, 2023

Record last verified: 2022-03

Locations

ES (2)