Effects of COVID-19 Hospitalization on Physical Performance

NCT04751630 | Completed

• 1 other identifier: CBAS-21-22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Upper limb strength change

  handgrip strength test

  Change from Baseline upper limb strength at 6 weeks

Secondary Outcomes (4)

• Physical Performance change

  Change from Baseline physical performance at 6 weeks

• Walking speed change

  Change from Baseline walking speed at 6 weeks

• lower limb strength change

  Change from Baseline lower limb strength at 6 weeks

• Fraility change

  Change from Baseline fraility at 6 weeks

Study Arms (2)

Therapeutic Exercise group

EXPERIMENTAL

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.

Other: Therapeutic Exercise

Control group

NO INTERVENTION

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.

Interventions

Therapeutic Exercise 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.

Therapeutic Exercise group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Hospital Arnau de Vilanova

Lleida, 25003, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Albert Pérez-Bellmunt, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: June 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

ES (1)