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

Not Applicable

Not yet recruiting

• Conditions: COVID-19
• Interventions: Other: Aerobic plus strength group; Other: Aerobic group

• Registration Number: NCT05665205
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-27
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-29
• Study Start: 2023-01-30
• Primary Completion: 2023-01-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise plus strength	Aerobic plus strength group	The purpose is to verify if the aerobic exercise plus a strength program improves more than aerobic exercise alone in COVID patients.
Aerobic exercise alone	Aerobic group	The purpose is to verify if COVID patients can improve the status of their health only with an aerobic exercise program alone.

Primary Outcome Measures

Name	Time	Method
6MWT	6 minutes	The 6-minute walking test (6MWT) measured the cardiovascular endurance and the Functional Independence Measure assessed the global functional capacity
sf 36	36 minutes	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'"
Timed up and Go (TUG)	5-7 minutes	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

Secondary Outcome Measures

Name	Time	Method
Heart beat	45 min	the heart beat will be measured before and during the treatment sessions
BORG	10 seconds	it is a scale that has been used to evaluate the degree of dyspnea (0=no dyspnea, 10=worse dyspnea)
SARC-F questionnaire	10 minutes	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
Ecography	2-3 minutes	quadriceps muscle length will be measured
Saturation	45 min	Before the session and during the itself will be measured

Trial Locations

Locations (1)

David Fernández; 🇪🇸 Madrid, Spain