Benefits of an Aerobic and Strength Rehabilitation Program With Post- SARS-CoV-2 Patients Moderate-severe (SARS-CoV-2)

Benefits of an Aerobic and Strength Rehabilitation Program With Post-SARS-CoV-2 Patients Moderate-severe

The SARS-CoV-2 is a pulmonary pathology which is caused by SARS-COV2 and the main signs and symptoms are fever, dyspnea, cough, fatigue, muscular pain and more. Even if SARS-CoV-2 is an acute respiratory pathology we know that can cause some chronic conditions in the general status health of the patients. Besides, it can have an important impact in the physique condition such as a detrimental of the aerobic capacity, lung capacity based on the severity of the patient.

On the other hand, World Health Organization (WHO) has a criteria to classify the severity of SARS-CoV-2;

Saturation de O2 <94%,

PaO2/FiO2: <300mm

Frecuencia respiratoria > 30p/m

abscess Lung > 50%

septic shock

Multiorganic failure

Based on the high survival but the important number of side effects of this pathology remaining the detrimental of the health and exercise condition. We justify our study based on an aerobic exercise program with a strength part to improve those conditions of the patients.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Aerobic plus strength group; Other: Aerobic group

Detailed Description

The investigators develop an aerobic exercise program for two treatment groups which one of them has a strength program as a supplement to verify if the aerobic exercise plus strength improve more than aerobic exercise alone the condition of COVID patients.

The protocol is based on 8 weeks of program with a baseline measurements and a follow ups after the 8º weeks, at 2, 4 and six months after finish the treatment to compare the effectiveness of both treatment and between them.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Fernández, Msc; Phone Number: 696306962; Email: david.fisioterapeuta14@gmail.com
• Study Contact Backup: Name: Astrid Texeira Taborda, msc; Email: astrid.teixeira@hgvillalba.es

Study Locations

• Spain
  • Madrid, Spain, 28015
    • David Fernández
    • Contact: David Fernández, Msc; Phone Number: 696306962; Email: david.fisioterapeuta14@gmail.com
    • Principal Investigator: Astrid Texeira Taborda, Msc
    • Principal Investigator: David Fernández, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients had been got covid in the last 2 years.
• No fractures, or major injuries which could compromised the movements of the patient
• No major pathologies which deteriorate the general health status

Exclusion Criteria:

• Psychiatric (moderate to severe)
• Acute infection
• Fractures (moderate to severe)
• Cognitive detrimental state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic exercise plus strength; The purpose is to verify if the aerobic exercise plus a strength program improves more than aerobic exercise alone in COVID patients.	Other: Aerobic plus strength group; A 8 week program of aerobic exercise plus strength exercise of upper and lower limbs in the hospital with a supervised trained physiotherapist
Sham Comparator: Aerobic exercise alone; The purpose is to verify if COVID patients can improve the status of their health only with an aerobic exercise program alone.	Other: Aerobic group; This group has a 8 weeks program of only aerobic exercise in the hospital with a supervised trained physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	The 6-minute walking test (6MWT) measured the cardiovascular endurance and the Functional Independence Measure assessed the global functional capacity	6 minutes
sf 36	The 36-Item Short Form Health Survey (SF-36) is a widely it. The measure meets high psychometric standards [20, 21]. The 36 items represent eight scales: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. These eight scales form two higher order constructs: physical health (the first four scales) and mental health (the latter four scales). These constructs are represented by two summary measures: Physical Component Summary (PCS) measure and Mental Component Summary (MCS) measure. Scoring was completed as per standard instructions, using norm-based scoring algorithms. Lower scores on the MCS refect "frequent psychological distress, substantial social and role disability due to emotional problems; health in general rated 'poor'". Lower scores on the PCS refect "Substantial limitations in self-care, physical, social, and role activities; severe bodily pain; frequent tiredness; health rated 'poor'"	36 minutes
Timed up and Go (TUG)	Functional mobility was assessed through the timed up-and-go (TUG) test, five times sit-to-stand (FTSTS) test, functional reach and balance confidence. The TUG test measures the time taken by a participant to stand from a sitting position, walk 3 m, return and sit back down and is a measure of mobility. The FTSTS measures the time taken by a participant to switch from sitting-to-standing five times in a row and is a test of functional strength. Functional reach measures the distance a participant can reach forward with his or her arm outstretched while standing and is a test of balance. For each test, participants completed a practice run before the actual measurement	5-7 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BORG	it is a scale that has been used to evaluate the degree of dyspnea (0=no dyspnea, 10=worse dyspnea)	10 seconds
Ecography	quadriceps muscle length will be measured	2-3 minutes
Heart beat	the heart beat will be measured before and during the treatment sessions	45 min
Saturation	Before the session and during the itself will be measured	45 min
SARC-F questionnaire	SARC-F includes five components: strength, assistance walking, rise from a chair, climb stairs, and falls. SARC-F items were selected to reflect health status changes associated with the consequences of sarcopenia. SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) and were dichotomized to represent symptomatic (4+) vs. healthy (0-3) status	10 minutes

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: David Fernández, msc, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Publications and helpful links

General Publications

• Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.
• Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2023
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; COVID; Strenght exercise; Aerobic program
• Other Study ID Numbers: COV_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: When the study will be completed and published, It will be available to share with more researches.
• IPD Sharing Time Frame: The data will become available at the end of the last follow up to have all data for the Statistical analysis.
• IPD Sharing Access Criteria: All data Access will be possible when the manuscript will be published in a Journal.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No