An interventional study of physiotherapy in Respiratory Insufficiency and Anxiety State, sponsored by Hospital Universitario Getafe. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Hospital Universitario Getafe · Not applicable, Interventional, and Prevention
Based on the hypothesis that early physiotherapy in patients hospitalized for COVID-19 improves their functional capacity, perceived quality of life and decreases anxiety. Our main objective is to analyze the differences between groups with respect to functional deterioration, need for oxygen therapy and anxiety when implementing an early physiotherapy program.
We propose a randomized clinical trial with two arms and single-center, to be developed in hospitalization units and intermediate respiratory care units (IRCU), with patients diagnosed with COVID. The sample will consist of an experimental group of 66 admitted patients with COVID-19 to whom an early physiotherapy program will be implemented from 48-72 hours after admission. The control group will be made up of another 66 admitted patients with COVID-19 who will receive the treatment according to the usual procedure of the hospital center.
Sociodemographic and clinical variables will be collected, including: modified MMRC dyspnea scale, amount of oxygen therapy, MRC-SS, sit to stand test, hand grip, Tinetti, HADS anxiety and depression questionnaire, SF-12 quality of life questionnaire, clinical frailty scale (CFS) and FRAIL scale. Patients in both groups will be re-evaluated two months after hospital discharge with the above variables in addition to the PCFS post-COVID patient functional status scale.
A basic descriptive analysis and logistic regression will be performed to determine the effect of the intervention.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's enrollment of 122 is above the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Hospital Universitario Getafe is the lead sponsor of 29 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
48-72 hours after hospital admission, following the baseline assessment of the patient, they will begin to receive physiotherapy treatment with respiratory techniques and motor training, adapted at all times to the clinical situation of the patient, until hospital discharge. If the patient's clinical condition worsens, treatment will be temporarily suspended until the patient improves to allow resumption of treatment.
Other: physiotherapy
48-72 hours after admission to the hospital, after the patient's baseline assessment, the patient will not receive physiotherapy and the usual referral to the Rehabilitation Service for physiotherapy treatment of hospitalized patients will be followed, if the patient's physician considers it necessary and requests it.
Patients in the intervention group will receive early physiotherapy treatment. This intervention will consist of exercises and physiotherapy techniques commonly used and aimed at improving the patient's respiratory and motor conditioning. At the respiratory level: diaphragmatic and costal targeted ventilation, pursed-lip breathing and bronchial hygiene techniques if required. At the motor level: passive, active-assisted kinesitherapy and analytical and global potentiation of the upper and lower limbs that will allow the maintenance and improvement of the articular pathway and will prevent muscle weakness; retraining of transfers and balance; gait reeducation.
Respiratory competence
Monitoring and assessment of the respiratory capacity of patients during hospital admission
Time frame: 4 months
Motor competence
Monitoring and assessment of patients' motor skills during hospital admission
Time frame: 4 months
Anxiety state
assessment of the anxiety state of patients on admission and after discharge from hospital
Time frame: 4 months
Variation in the level of quality of life
Assessment of patients' quality of life prior to hospital admission and two months after discharge
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Getafe