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

NCT ID: NCT05665205

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Keywords

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Rehabilitation COVID Strenght exercise Aerobic program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Aerobic plus strength group

Intervention Type 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 alone

The purpose is to verify if COVID patients can improve the status of their health only with an aerobic exercise program alone.

Group Type SHAM_COMPARATOR

Aerobic group

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Aerobic group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role lead

Responsible Party

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David Fernández

Benefits of an aerobic and strength program with Post-SARS-CoV-2 patients moderate-severe

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Fernández, msc

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Locations

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David Fernández

Madrid, , Spain

Site Status

Countries

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Spain

Central Contacts

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David Fernández, msc

Role: CONTACT

Phone: 696306962

Email: [email protected]

Astrid Texeira Taborda, msc

Role: CONTACT

Email: [email protected]

Facility Contacts

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David Fernández, Msc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30489442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18570798 (View on PubMed)

Other Identifiers

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COV_2022

Identifier Type: -

Identifier Source: org_study_id