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

COVID-19 Clinical Trial

— SARS-CoV-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05665205
• Other study ID #: COV_2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2022
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: David Fernández, msc
• Phone: 696306962
• Email: david.fisioterapeuta14[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Spain	David Fernández	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	The 6-minute walking test (6MWT) measured the cardiovascular endurance and the Functional Independence Measure assessed the global functional capacity	6 minutes
Primary	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
Primary	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	BORG	it is a scale that has been used to evaluate the degree of dyspnea (0=no dyspnea, 10=worse dyspnea)	10 seconds
Secondary	Ecography	quadriceps muscle length will be measured	2-3 minutes
Secondary	Heart beat	the heart beat will be measured before and during the treatment sessions	45 min
Secondary	Saturation	Before the session and during the itself will be measured	45 min
Secondary	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