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| Name | Class |
|---|---|
| Spanish Primary Health Care | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council Dyspnea Score. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa José DÃaz-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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarÃa José DÃaz Arribas | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38320238 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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The participants will be randomly allocated to Tele-physiotherapy or control groups.
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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.
|
| Baseline. |
| Modified Medical Research Council Dyspnea Score. | 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. | 6 weeks. |
| Modified Medical Research Council Dyspnea Score. | 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. | 10 weeks. |
| Modified Medical Research Council Dyspnea Score. | 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. | 14 weeks. |
| Saint George Respiratory Questionnaire. | 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). | Baseline. |
| Saint George Respiratory Questionnaire. | 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 weeks. |
| Saint George Respiratory Questionnaire. | 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). | 10 weeks. |
| Saint George Respiratory Questionnaire. | 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). | 14 weeks. |
| 6-Minute Walk Test (6MWT). | 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. | Baseline. |
| 6-Minute Walk Test (6MWT). | 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. | 6 weeks. |
| 6-Minute Walk Test (6MWT). | 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 weeks. |
| 6-Minute Walk Test (6MWT). | 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. | 14 weeks. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005791 |
| Patient Care |