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Effects of COVID-19 Hospitalization on Physical Performance

Primary Purpose

Covid19, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Exercise
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Exercise group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Upper limb strength change
handgrip strength test

Secondary Outcome Measures

Physical Performance change
Short Physical Performance Battery test
Walking speed change
4 meters walking speed
lower limb strength change
5 times sit and reach test
Fraility change
FRAIL scale

Full Information

First Posted
February 9, 2021
Last Updated
March 10, 2022
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04751630
Brief Title
Effects of COVID-19 Hospitalization on Physical Performance
Official Title
Effects of a Structured Online Therapeutic Exercise Program on Physical Performance in COVID-19 Patients at Discharge Time.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Physical Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper limb strength change
Description
handgrip strength test
Time Frame
Change from Baseline upper limb strength at 6 weeks
Secondary Outcome Measure Information:
Title
Physical Performance change
Description
Short Physical Performance Battery test
Time Frame
Change from Baseline physical performance at 6 weeks
Title
Walking speed change
Description
4 meters walking speed
Time Frame
Change from Baseline walking speed at 6 weeks
Title
lower limb strength change
Description
5 times sit and reach test
Time Frame
Change from Baseline lower limb strength at 6 weeks
Title
Fraility change
Description
FRAIL scale
Time Frame
Change from Baseline fraility at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Pérez-Bellmunt, PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of COVID-19 Hospitalization on Physical Performance

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