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

NCT05665205 | Unknown DMC

• 1 other identifier: COV_2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

Rehabilitation; COVID; Strenght exercise; Aerobic program

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• BORG

  10 seconds

• Ecography

  2-3 minutes

• Heart beat

  45 min

• Saturation

  45 min

• SARC-F questionnaire

  10 minutes

Study Arms (2)

Aerobic exercise plus strength

ACTIVE COMPARATOR

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

Aerobic exercise alone

SHAM COMPARATOR

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

Interventions

Aerobic plus strength group OTHER

A 8 week program of aerobic exercise plus strength exercise of upper and lower limbs in the hospital with a supervised trained physiotherapist

Aerobic exercise plus strength

Aerobic group OTHER

This group has a 8 weeks program of only aerobic exercise in the hospital with a supervised trained physiotherapist.

Aerobic exercise alone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

David Fernández

Madrid, 28015, Spain

Location

Related Publications (2)

• 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.

  PMID: 30489442 BACKGROUND

• 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.

  PMID: 18570798 BACKGROUND

MeSH Terms

Conditions

COVID-19

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

Study Officials

• David Fernández, msc

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Fernández, msc

CONTACT

696306962; david.fisioterapeuta14@gmail.com

Astrid Texeira Taborda, msc

CONTACT

astrid.teixeira@hgvillalba.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Main investigators will be masked based on a randomization program. Outcomes Assessors will be not aware of the enrollment of participants and the study design to guaranty blinding of themselves. Participants will be randomized by a program and they will not be aware about which groups could be more beneficial to guarantee blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Benefits of an aerobic and strength program with Post-SARS-CoV-2 patients moderate-severe

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: December 27, 2022
• Study Start: January 30, 2023
• Primary Completion: January 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available at the end of the last follow up to have all data for the Statistical analysis.
• Access Criteria: All data Access will be possible when the manuscript will be published in a Journal.

Locations

ES (1)