Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coronavirus
  • Fatigue
  • Musculoskeletal Complication
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge. At the second phase, a feasibility pilot study with a single-blinded randomized clinical trial design with volunteer patients admitted to hospital and recruited ...

At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge. At the second phase, a feasibility pilot study with a single-blinded randomized clinical trial design with volunteer patients admitted to hospital and recruited at the time of discharge by COVID-19 will evaluate a physiotherapy programme. There will be an intervention group (asynchronous telerehabilitation at home) and a control group (home rehabilitation by means of an explanatory leaflet). The intervention will be carried out for 12 weeks with a follow-up at 3 and 6 months. Intervention: The physical rehabilitation programme will be designed with three levels of intensity of aerobic, strength and respiratory exercises, and a list of recommendations for self-management of the sequelae of the COVID-19. The intervention will last for a total of 12 weeks at home (three days a week for 45-60 minutes a day) with a biweekly phone check-up. All patients will be provided with the same physical rehabilitation and educational programme, with each allocation group differing in the format of the prescription. Experimental group A programme with exercise videos and health recommendations will be prescribed through a telerehabilitation platform to improve fatigue and fitness resulting from COVID-19. The application will be installed on patients' mobile phones and its use will be explained to them so that they can carry out the programme from their homes. Control group The control group will receive a paper booklet with clear pictures and descriptions of the exercise and educative programme to improve fatigue and fitness. Assessment: Fatigue will be assessed with the fatigue severity scale (FSS). Functional capacity will be measured through operation: with the Post-COVID Functional Status Scale (PCFS), the strength with the 30" sit-to-stand (STST), the 30" arm curl test (ACT), and through aerobic capacity with de six minutes walking test (6MWT). Psychosocial factors will be measured with the general self-efficacy scale (GSES), the depression and anxiety scale (DASS-21), the behavioral regulation questionnaire in sport (BRSQ) and the multidimensional scale of perceived social support (MSPSS). Quality of life will be measured with the quality of life scale (SF-12). Adherence and engagement be measured by diary recording and satisfaction with a brief interview. Outcome measures: Fatigue, functional status post-COVID-19, strength, aerobic capacity, anxiety and depression, behavior in sport, perceived social support and quality of life will be evaluated before intervention, after intervention (12 weeks) at 3 and 6 months for follow-up. Adherence and satisfaction will be evaluated after intervention (12 weeks) and during intervention (each 15 days).

Tracking Information

NCT #
NCT04794036
Collaborators
  • Hospital Real Nuestra Señora de Gracia
  • Hospital Royo Villanova
Investigators
Principal Investigator: Carolina Jiménez Sánchez, MD Universidad San Jorge Principal Investigator: Sandra Calvo, Dr Universidad San Jorge