Effects of COVID-19 Hospitalization on Physical Performance

NCT ID: NCT04751630

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-03-01

Brief Summary

Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.

The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.

Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.

Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.

Conditions

Covid19; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapeutic Exercise group

The study participants corresponding to the Therapeutic Exercise (ET) intervention group will follow the prescriptions given to them by their primary care physician. In addition, and as the main part of the intervention, they will undergo a six-week ET program with two sessions per week, for a total of 12 sessions. Full participation in 10 sessions will be necessary to be included in the ET group during the statistical analysis. Each session will be one hour long. The sessions will be given and supervised by a physiotherapist expert in therapeutic exercise prescription through the online modality.

Group Type: EXPERIMENTAL

Therapeutic Exercise

Intervention Type: OTHER

Online and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist.

Control group

Study participants in the control group will follow the prescriptions given to them by their primary care physician and will receive a weekly call to assess their recovery. At the end of the study follow-up, when their participation in the study as a control group ends, participants in this group will be offered to participate in the structured ET program to be carried out by the ET group. The reason for this is to ensure that the entire sample ends up receiving a treatment that, a priori, should improve their functional capacities, thus guaranteeing one of the ethical principles of the research.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapeutic Exercise

Online and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older.
• Have been diagnosed COVID-19 positive at the time of hospital admission.
• Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
• Be able to read the informed consent form and understand the objectives and conduct of the study.

Exclusion Criteria

• Diagnosed neurological or psychiatric disease.
• Contraindications to physical exercise.
• Failure to give informed consent for the study.
• Unavailability to perform the ET program twice a week.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Albert Pérez Bellmunt

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Pérez-Bellmunt, PhD

Role: STUDY_DIRECTOR

Universitat Internacional de Catalunya

Locations

Hospital Arnau de Vilanova

Lleida, , Spain

Countries

Spain

Other Identifiers

CBAS-21-22

Identifier Type: -

Identifier Source: org_study_id