COVID-19TPhysioCovidNCT05121688
Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
A study testing Physiotherapy in people with COVID-19 and Physical Therapy Modalities, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- COVID-19, Physical Therapy Modalities, Telerehabilitation
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2021to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patients with cognitive problems. Mini-Cognitive Lobo exam greater than 23 points
- Active bleeding.
- Unstable fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multimodal 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.
Read the 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.
- Being tested
- Physiotherapy
- Keywords
- COVID-19, Physical Therapy, Telerehabilitation, Primary Health Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Therapeutic exercise
A Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 14 weeks.
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start25 Nov 2021
- Primary completion15 May 2022
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly allocated to Tele-physiotherapy or control groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Primary Health Care
- Responsible party
- Principal investigator, MARIA JOSE DIAZ ARRIBAS, Universidad Complutense de Madrid
- Investigators
- María José Díaz-Arribas, PhD., Principal investigator, Director of Physical Therapy Section.Gustavo Plaza Manzano, PhD., Study director, Sub-director of Pysical Therapy Section.Mabel Ramos Sánchez, PhD., Study director, Tenured University Professor.José Calvo Paniagua, Master, Principal investigator, Associated Clinical Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121688
- Sponsor's protocol ID
- UCMadrid
- Acronym
- TPhysioCovid
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38320238
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
- ClinicalTrials.gov ID
- NCT05121688
- Acronym / sponsor ID
- TPhysioCovid / UCMadrid
- Keywords
- COVID-19, Physical Therapy, Telerehabilitation, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Spanish Primary Health Care
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated to Tele-physiotherapy or control groups.
| Arm | Type | Receives |
|---|---|---|
| Tele-physiotherapy group | Experimental | Other: PhysiotherapyAllocated 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. |
| Control group | Active comparator | Other: PhysiotherapyNo 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: Therapeutic exerciseA Tele-face-to-face multimodal physical therapy program based on health education, respiratory exercises, physical training exercises, aerobic exercises and functional mobility. | Other | Control group, Tele-physiotherapy group |
Primary outcome
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).
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).
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).
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).
12 secondary outcomes
Modified Medical Research Council Dyspnea Score.
Time frame: Baseline.
Modified Medical Research Council Dyspnea Score.
Time frame: 6 weeks.
Modified Medical Research Council Dyspnea Score.
Time frame: 10 weeks.
Modified Medical Research Council Dyspnea Score.
Time frame: 14 weeks.
Saint George Respiratory Questionnaire.
Time frame: Baseline.
Saint George Respiratory Questionnaire.
Time frame: 6 weeks.
Saint George Respiratory Questionnaire.
Time frame: 10 weeks.
Saint George Respiratory Questionnaire.
Time frame: 14 weeks.
6-Minute Walk Test (6MWT).
Time frame: Baseline.
6-Minute Walk Test (6MWT).
Time frame: 6 weeks.
6-Minute Walk Test (6MWT).
Time frame: 10 weeks.
6-Minute Walk Test (6MWT).
Time frame: 14 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 38320238Calvo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María José Díaz-Arribas, PhD. principal investigator
Director of Physical Therapy Section.
Gustavo Plaza Manzano, PhD. study director
Sub-director of Pysical Therapy Section.
Mabel Ramos Sánchez, PhD. study director
Tenured University Professor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with COVID-19 and Physical Therapy Modalities, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg scale. (time frame: Baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.