Clinical trial NCT05121688: Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
Official title: Effectiveness of a Multimodal Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Physical Therapy Modalities
Telerehabilitation
Primary Health Care
Keywords: COVID-19
Physical Therapy
Telerehabilitation
Primary Health Care
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Spanish Primary Health Care
First posted: 2021-11-16
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated to Tele-physiotherapy or control groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Borg scale.
timeFrame: Baseline.
measure: Modified Borg scale.
timeFrame: 6 weeks.
measure: Modified Borg scale.
timeFrame: 10 weeks.
measure: Modified Borg scale.
timeFrame: 14 weeks.
Secondary outcomes:
measure: Modified Medical Research Council Dyspnea Score.
timeFrame: Baseline.
measure: Modified Medical Research Council Dyspnea Score.
timeFrame: 6 weeks.
measure: Modified Medical Research Council Dyspnea Score.
timeFrame: 10 weeks.
measure: Modified Medical Research Council Dyspnea Score.
timeFrame: 14 weeks.
measure: Saint George Respiratory Questionnaire.
timeFrame: Baseline.
measure: Saint George Respiratory Questionnaire.
timeFrame: 6 weeks.
measure: Saint George Respiratory Questionnaire.
timeFrame: 10 weeks.
measure: Saint George Respiratory Questionnaire.
timeFrame: 14 weeks.
measure: 6-Minute Walk Test (6MWT).
timeFrame: Baseline.
measure: 6-Minute Walk Test (6MWT).
timeFrame: 6 weeks.
measure: 6-Minute Walk Test (6MWT).
timeFrame: 10 weeks.
measure: 6-Minute Walk Test (6MWT).
timeFrame: 14 weeks.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: María José Díaz Arribas
Study officials:
affiliation: Director of Physical Therapy Section.
name: María José Díaz-Arribas, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sub-director of Pysical Therapy Section.
name: Gustavo Plaza Manzano, PhD.
role: STUDY_DIRECTOR
affiliation: Tenured University Professor.
name: Mabel Ramos Sánchez, PhD.
role: STUDY_DIRECTOR
affiliation: Associated Clinical Professor
name: José Calvo Paniagua, Master
role: PRINCIPAL_INVESTIGATOR
References: