Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care. (TPhysioCovid)

Universidad Complutense de Madrid

Status: Completed

Conditions: COVID-19; Telerehabilitation; Primary Health Care; Physical Therapy Modalities

Treatments: Other: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05121688

UCMadrid

Details and patient eligibility

About

The evolution of Coronavirus disease 2019 (COVID-19) pandemic makes it more necessary the intervention of Primary Health Care Physiotherapy Units in patients with respiratory and/or functional sequelae after suffering from SARS-CoV-2 (acute respiratory sindrome by coronavirus) virus infection.

Since some months ago, Primary Health Care use telerehabilitation tools to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical therapy interventions to patients' complications after COVID-19 by using a videoconferencing method. The aim of this study is to evaluate the effectiveness of a multimodal Physical Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health Care.

Full description

Coronavirus disease 2019 (COVID-19), is a multisystem infectious disease which has led to a global pandemic. The evolution of COVID-19 disease makes it more necessary the intervention of Primary Health Care Physiotherapy Units in patients with respiratory and /or functional sequelae after suffering from SARS-CoV-2 infection. Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with persistent post COVID-19.

Since some months ago, Primary Health Care use telerehabilitation tools to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical therapy interventions to patients' complications after COVID-19 by using a videoconferencing method. The aim of this study is to evaluate the effectiveness of a multimodal Physical Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health Care.

Enrollment: 71 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with long post-COVID symptoms (from week 12 to week 24).
• Patients between 25 and 70 years old.
• Patients with moderate respiratory and/or functional affectation with long post COVID-19 symptoms, belonging to four Physiotherapy Units of primary Health Care in Madrid (Spain).
• Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
• Persistent symptoms lasting ≥12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified Medical Research Council (mMRC) score ≥1).
• Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
• Participant owns a smart phone, tablet, or computer to access on-line sessions.

Exclusion criteria

• People with symptoms such as fever, cough, upper respiratory distress, diarrhea, vomiting, anosmia or ageusia.
• Temperature greater than 37.2 degrees Celsius.
• Patients with multimorbidity. Multimorbidity will be considered when the patient is diagnosed with two or more diseases among the following: diabetes, dyslipidaemia, cardiovascular disease (arterial hypertension, ischemic heart disease, valvular heart disease, heart failure), osteoarthritis, respiratory disease (asthma, chronic bronchitis), digestive disease ( gastric or duodenal ulcers, inflammatory bowel disease, liver disease), psychiatric pathology or tumor pathology.
• Patients with previous pathologies: ischemic heart disease, dementia, lung failure, lung cancer, cystic fibrosis, pulmonary fibrosis, chronic kidney failure, liver diseases, myocardial arrhythmias, deep vein thrombosis, severe aortic stenosis, liver diseases.
• Patients with weakened immune systems: in cancer treatment, organ or marrow transplant patients, HIV/AIDS, prolonged use of prednisone or similar medication.
• Patients with functional limitations to carry out their basic activities of daily living. Barthel index greater than 90.
• Patients with cognitive problems. Mini-Cognitive Lobo exam greater than 23 points
• Active bleeding.
• Unstable fractures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

Tele-physiotherapy group

Experimental group

Description:

Allocated participants to intervention group will receive 18 Tele-physiotherapy sessions (three sessions per week, with 30 min. of duration) during six weeks. In this sessions, participants will carry out a tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility. This group will receive conventional medical care too.

Treatment:

Other: Physiotherapy

Control group

Active Comparator group

Description:

No Physical therapy intervention. Allocated participants to control group will receive one consultation session by the physiotherapist, but will not received any physical Therapy treatment. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking. Conventional medical care will be provided. In the control group, the same measurements will be made at the same times as the subjects in the intervention group. Once the study is finished, the researcher agrees to carry out the intervention to the patients in the control group.

Treatment:

Other: Physiotherapy