Clinical trial NCT05665205: Benefits of an Aerobic and Strength Rehabilitation Program With Post- SARS-CoV-2 Patients Moderate-severe
Official title: Benefits of an Aerobic and Strength Rehabilitation Program With Post-SARS-CoV-2 Patients Moderate-severe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Rehabilitation
COVID
Strenght exercise
Aerobic program
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6MWT
timeFrame: 6 minutes
measure: sf 36
timeFrame: 36 minutes
measure: Timed up and Go (TUG)
timeFrame: 5-7 minutes
Secondary outcomes:
measure: BORG
timeFrame: 10 seconds
measure: Ecography
timeFrame: 2-3 minutes
measure: Heart beat
timeFrame: 45 min
measure: Saturation
timeFrame: 45 min
measure: SARC-F questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: David Fernández
Study officials:
affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: David Fernández, msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.