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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05665205
Acronym
SARS-CoV-2
Enrollment
20
Registered
2022-12-27
Start date
2023-01-30
Completion date
2023-08-30
Last updated
2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Rehabilitation, COVID, Strenght exercise, Aerobic program

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.

Interventions

OTHERAerobic 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

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

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6MWT6 minutesThe 6-minute walking test (6MWT) measured the cardiovascular endurance and the Functional Independence Measure assessed the global functional capacity
sf 3636 minutesThe 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 minutesFunctional 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

MeasureTime frameDescription
Saturation45 minBefore the session and during the itself will be measured
BORG10 secondsit is a scale that has been used to evaluate the degree of dyspnea (0=no dyspnea, 10=worse dyspnea)
SARC-F questionnaire10 minutesSARC-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
Ecography2-3 minutesquadriceps muscle length will be measured
Heart beat45 minthe heart beat will be measured before and during the treatment sessions

Countries

Spain

Contacts

Primary ContactDavid Fernández, msc
david.fisioterapeuta14@gmail.com696306962
Backup ContactAstrid Texeira Taborda, msc
astrid.teixeira@hgvillalba.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026