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

NCT05121688 | Completed

• 1 other identifier: UCMadrid
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Modified Borg scale.

  Modified Borg scale, or scale of perceived exertion, is a subjective scale to measure the intensity of a physical effort, quantifying the respiratory distress. The modified Borg Scale is averaged from 0 to 10. Perceived effort will be measured as 0-2 (light effort), 3-4 (moderate effort), 5-6 (hard effort), 7-9 (very hard effort) and 10 (maximum effort).

  Baseline.

• Modified Borg scale.

  Modified Borg scale, or scale of perceived exertion, is a subjective scale to measure the intensity of a physical effort, quantifying the respiratory distress. The modified Borg Scale is averaged from 0 to 10. Perceived effort will be measured as 0-2 (light effort), 3-4 (moderate effort), 5-6 (hard effort), 7-9 (very hard effort) and 10 (maximum effort).

  6 weeks.

• Modified Borg scale.

  Modified Borg scale, or scale of perceived exertion, is a subjective scale to measure the intensity of a physical effort, quantifying the respiratory distress. The modified Borg Scale is averaged from 0 to 10. Perceived effort will be measured as 0-2 (light effort), 3-4 (moderate effort), 5-6 (hard effort), 7-9 (very hard effort) and 10 (maximum effort).

  10 weeks.

• Modified Borg scale.

  Modified Borg scale, or scale of perceived exertion, is a subjective scale to measure the intensity of a physical effort, quantifying the respiratory distress. The modified Borg Scale is averaged from 0 to 10. Perceived effort will be measured as 0-2 (light effort), 3-4 (moderate effort), 5-6 (hard effort), 7-9 (very hard effort) and 10 (maximum effort).

  14 weeks.

Secondary Outcomes (12)

• Modified Medical Research Council Dyspnea Score.

  Baseline.

• Modified Medical Research Council Dyspnea Score.

  6 weeks.

• Modified Medical Research Council Dyspnea Score.

  10 weeks.

• Modified Medical Research Council Dyspnea Score.

  14 weeks.

• Saint George Respiratory Questionnaire.

  Baseline.

Study Arms (2)

Tele-physiotherapy group

EXPERIMENTAL

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.

Other: Physiotherapy

Control group

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

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

Also known as: Therapeutic exercise

Control group; Tele-physiotherapy group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Spanish Primary Health Care: collaborator

Study Sites (1)

María José Díaz Arribas

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 38320238 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Physical Therapy Modalities; Exercise Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• María José Díaz-Arribas, PhD.

  Director of Physical Therapy Section.

  PRINCIPAL INVESTIGATOR

• Gustavo Plaza Manzano, PhD.

  Sub-director of Pysical Therapy Section.

  STUDY DIRECTOR

• Mabel Ramos Sánchez, PhD.

  Tenured University Professor.

  STUDY DIRECTOR

• José Calvo Paniagua, Master

  Associated Clinical Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator and the assessor will be blinded to the randomization and allocation. The assessor will have not access to patients' medical record. Patients will be also asked to do not explain about their procedure to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Model Details: The participants will be randomly allocated to Tele-physiotherapy or control groups.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 16, 2021
• Study Start: November 25, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 9, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)