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

NCT ID: NCT05121688

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2023-05-09

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tele-physiotherapy group

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.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

A Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

A Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility.

Interventions

Physiotherapy

A Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility.

Intervention Type: OTHER

Other Intervention Names

Therapeutic exercise

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Primary Health Care

UNKNOWN

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

MARIA JOSE DIAZ ARRIBAS

University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María José Díaz-Arribas, PhD.

Role: PRINCIPAL_INVESTIGATOR

Director of Physical Therapy Section.

Gustavo Plaza Manzano, PhD.

Role: STUDY_DIRECTOR

Sub-director of Pysical Therapy Section.

Mabel Ramos Sánchez, PhD.

Role: STUDY_DIRECTOR

Tenured University Professor.

José Calvo Paniagua, Master

Role: PRINCIPAL_INVESTIGATOR

Associated Clinical Professor

Locations

María José Díaz Arribas

Madrid, , Spain

Countries

Spain

References

Calvo-Paniagua J, Diaz-Arribas MJ, Valera-Calero JA, Ramos-Sanchez M, Fernandez-de-Las-Penas C, Navarro-Santana MJ, Del Corral T, Plaza-Manzano G. Educational, Exercise, and Occupational Therapy-Based Telerehabilitation Program Versus "Wait-and-See" for Improving Self-perceived Exertion in Patients With Post-COVID Fatigue and Dyspnea: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2024 Sep 1;103(9):797-804. doi: 10.1097/PHM.0000000000002441. Epub 2024 Jan 31.

Reference Type: DERIVED

PMID: 38320238 (View on PubMed)

Other Identifiers

UCMadrid

Identifier Type: -

Identifier Source: org_study_id