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Completed

NCT Number: NCT05121688

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Physical Therapy Modalities Pneumonia Pneumonia, Viral Primary Health Care RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Telerehabilitation Virus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María José Díaz Arribas

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Therapeutic exercise

Primary outcomes

  1. Modified Borg scale.

    Time frame: Baseline.

    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).

  2. Modified Borg scale.

    Time frame: 6 weeks.

    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).

  3. Modified Borg scale.

    Time frame: 10 weeks.

    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).

  4. Modified Borg scale.

    Time frame: 14 weeks.

    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).

Secondary outcomes

  1. Modified Medical Research Council Dyspnea Score.

    Time frame: Baseline.

    Modified Medical Research Council Dyspnea Score (mMRC). The mMRC Dyspnea Score is used to establish baseline functional impairment due to dyspnea.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.

    Grade 0: absence of dyspnea when performing intense exercise. Grade 1: dyspnea when walking quickly on the flat or climbing. Grade 2: dyspnea does not allow walking with another person of the same age or the person has to stop to rest.

    Grade 3: dyspnea makes the patient stops to rest when walking for 100m or a few minutes after walking on the flat.

    Grade 4: dyspnea prevents the patient from leaving home or appears in activities of daily living.

  2. Modified Medical Research Council Dyspnea Score.

    Time frame: 6 weeks.

    Modified Medical Research Council Dyspnea Score (mMRC). The mMRC Dyspnea Score is used to establish baseline functional impairment due to dyspnea.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.

    Grade 0: absence of dyspnea when performing intense exercise. Grade 1: dyspnea when walking quickly on the flat or climbing. Grade 2: dyspnea does not allow walking with another person of the same age or the person has to stop to rest.

    Grade 3: dyspnea makes the patient stops to rest when walking for 100m or a few minutes after walking on the flat.

    Grade 4: dyspnea prevents the patient from leaving home or appears in activities of daily living.

  3. Modified Medical Research Council Dyspnea Score.

    Time frame: 10 weeks.

    Modified Medical Research Council Dyspnea Score (mMRC). The mMRC Dyspnea Score is used to establish baseline functional impairment due to dyspnea.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.

    Grade 0: absence of dyspnea when performing intense exercise. Grade 1: dyspnea when walking quickly on the flat or climbing. Grade 2: dyspnea does not allow walking with another person of the same age or the person has to stop to rest.

    Grade 3: dyspnea makes the patient stops to rest when walking for 100m or a few minutes after walking on the flat.

    Grade 4: dyspnea prevents the patient from leaving home or appears in activities of daily living.

  4. Modified Medical Research Council Dyspnea Score.

    Time frame: 14 weeks.

    Modified Medical Research Council Dyspnea Score (mMRC). The mMRC Dyspnea Score is used to establish baseline functional impairment due to dyspnea.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.

    Grade 0: absence of dyspnea when performing intense exercise. Grade 1: dyspnea when walking quickly on the flat or climbing. Grade 2: dyspnea does not allow walking with another person of the same age or the person has to stop to rest.

    Grade 3: dyspnea makes the patient stops to rest when walking for 100m or a few minutes after walking on the flat.

    Grade 4: dyspnea prevents the patient from leaving home or appears in activities of daily living.

  5. Saint George Respiratory Questionnaire.

    Time frame: Baseline.

    Saint George Respiratory Questionnaire (SGRQ) is a questionnaire to assess the quality of life in patients with respiratory problems. It is made up of 50 items divided into three scales: symptoms, activity and impact. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

  6. Saint George Respiratory Questionnaire.

    Time frame: 6 weeks.

    Saint George Respiratory Questionnaire (SGRQ) is a questionnaire to assess the quality of life in patients with respiratory problems. It is made up of 50 items divided into three scales: symptoms, activity and impact. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

  7. Saint George Respiratory Questionnaire.

    Time frame: 10 weeks.

    Saint George Respiratory Questionnaire (SGRQ) is a questionnaire to assess the quality of life in patients with respiratory problems. It is made up of 50 items divided into three scales: symptoms, activity and impact. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

  8. Saint George Respiratory Questionnaire.

    Time frame: 14 weeks.

    Saint George Respiratory Questionnaire (SGRQ) is a questionnaire to assess the quality of life in patients with respiratory problems. It is made up of 50 items divided into three scales: symptoms, activity and impact. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

  9. 6-Minute Walk Test (6MWT).

    Time frame: Baseline.

    6MWT is a test that measures the distance walked by each patient for 6 minutes, 30 meters on a flat and hard surface. The 6MWT assesses the level of submaximal functional capacity. The patient has to walk as far as possible for 6 minutes.

    Performance is classified into 4 categories:

    Category A: less than 350 meters; poor performance. Category B: between 350 and 450 meters; moderate performance. Category C: between 450 and 650 meters; good performance. Category D: more than 650 meters; excellent performance.

  10. 6-Minute Walk Test (6MWT).

    Time frame: 6 weeks.

    6MWT is a test that measures the distance walked by each patient for 6 minutes, 30 meters on a flat and hard surface. The 6MWT assesses the level of submaximal functional capacity. The patient has to walk as far as possible for 6 minutes.

    Performance is classified into 4 categories:

    Category A: less than 350 meters; poor performance. Category B: between 350 and 450 meters; moderate performance. Category C: between 450 and 650 meters; good performance. Category D: more than 650 meters; excellent performance.

  11. 6-Minute Walk Test (6MWT).

    Time frame: 10 weeks.

    6MWT is a test that measures the distance walked by each patient for 6 minutes, 30 meters on a flat and hard surface. The 6MWT assesses the level of submaximal functional capacity. The patient has to walk as far as possible for 6 minutes.

    Performance is classified into 4 categories:

    Category A: less than 350 meters; poor performance. Category B: between 350 and 450 meters; moderate performance. Category C: between 450 and 650 meters; good performance. Category D: more than 650 meters; excellent performance.

  12. 6-Minute Walk Test (6MWT).

    Time frame: 14 weeks.

    6MWT is a test that measures the distance walked by each patient for 6 minutes, 30 meters on a flat and hard surface. The 6MWT assesses the level of submaximal functional capacity. The patient has to walk as far as possible for 6 minutes.

    Performance is classified into 4 categories:

    Category A: less than 350 meters; poor performance. Category B: between 350 and 450 meters; moderate performance. Category C: between 450 and 650 meters; good performance. Category D: more than 650 meters; excellent performance.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Spanish Primary Health Care

Registry information

Official study title

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

Acronym: TPhysioCovid

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 16, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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