TelemedicineNCT05516836
Addressing Post-COVID-19 Musculoskeletal Symptoms
A study testing Multicomponent exercise program and Tele-health primary care rehabilitation program in people with Telemedicine and Musculoskeletal Disease, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The purpose of the study will be to evaluate the effect of a rehabilitation program on the improvement of patients with post-COVID-19 musculoskeletal symptoms, as well as to quantify the impact of telemedicine that evaluates the evolution of pain, functionality, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telemedicine, Musculoskeletal Disease, SARS-CoV-2
- What is being tested?
- Multicomponent exercise program and Tele-health primary care rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2023to 20 Sep 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need to be post-COVID-19 patients (ICU or non-ICU)
- Musculoskeletal symptoms
- Be of adult age (over 18 years)
Who cannot join
- Myocardial infarction
- Uncontrolled arrhythmia
- Recent pulmonary thromboembolism
- Terminal illness
- Patients undergoing lower limb unloading
- Lower or upper limb fractures in the last three months
Show all 15Show fewer
- Severe pain (score greater than 7 on the VAS of 10 points)
- Suffering from the previous pathology that causes neuromuscular weakness
- Be younger than 18 and older than 65 years old
- Influenced by medication that does not allow assessment of the real muscular functionality of the patient
- Patients with cognitive impairment that would prevent them from understanding and collaborating in the performance of the rehabilitation program plus telemedicine
- Patients with cardiorespiratory instability and uncontrolled arterial hypertension
- Systemic illness (tumor and rheumatologic diseases)
- Recent unrelated trauma
- Limiting psychiatric pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine
The purpose of the study will be to evaluate the effect of a rehabilitation program on the improvement of patients with post-COVID-19 musculoskeletal symptoms, as well as to quantify the impact of telemedicine that evaluates the evolution of pain, functionality, and quality of life.
Read the detailed description
A randomized clinical trial will be conducted in 100 patients with post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions. Data will be collected on the improvement of functional capacity and quality of life, in addition to assessing the evolution of musculoskeletal symptomatology, as well as pain and psychological variables. The telemedicine sessions will improve user adherence and follow-up, and the results are expected to be disseminated to the scientific community during and after the end of the study.
- Conditions
- Telemedicine, Musculoskeletal Disease, SARS-CoV-2, Pain, COVID-19, Exercise
- Being tested
- Multicomponent exercise program, Tele-health primary care rehabilitation program
- Keywords
- Telemedicine, SARS-CoV-2, Rehabilitation, Therapeutic exercise
- Medical subject headings
- Musculoskeletal Diseases, Pain, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise programOther
Each exercise session will have a duration of forty minutes in which the thirty minutes of intervallic work will be distributed as follows: twenty seconds until reaching 60% of their maximum load in the first seven sessions, adding five watts each day until reaching 80% of their maximum load in the fourteen sessions and seventy seconds of rest at 20% of their maximum load.
At the end of the sessions, strengthening exercises will be performed with elastic bands, adapting their resistance according to the characteristics of the patients, of the lower limbs and of the upper limbs. Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed.
Tele-health primary care rehabilitation programOther
A once a week telemedicine session will be carried out with the case group only before the face-to-face sessions, consisting of education, respiratory exercise, mobility and stretching, giving them a place to provide feedback and re-evaluate patients mid-treatment and will be aimed at assessing improvement and improving therapeutic adherence.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise program + Telemedicine | Experimental | The multicomponent exercise program lasted 6 weeks with sessions twice a week for a total of 12 sessions. It will have a duration of forty minutes in which the first five and the last five will be performed at a constant load of 5% of its maximum load corresponding to the "warm-up" and "return to calm". Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed.
A once a week telemedicine session will be carried out with the case group only before the face-to-face sessions, consisting of education, respiratory exercise, mobility and stretching, giving them a place to provide feedback and re-evaluate patients mid-treatment and will be aimed at assessing improvement and improving therapeutic adherence Receives: Other: Multicomponent exercise program; Other: Tele-health primary care rehabilitation program |
| Multicomponent exercise program | Active comparator | The multicomponent exercise program lasted 6 weeks with sessions twice a week for a total of 12 sessions. It will have a duration of forty minutes in which the first five and the last five will be performed at a constant load of 5% of its maximum load corresponding to the "warm-up" and "return to calm". Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed. Receives: Other: Multicomponent exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual grip strength
Grip strength will be measured in the affected hand and in the healthy hand (measuring the maximum grip strength). For this measurement, Handgrip strength averaging the result of three attempts with the dominant hand using a Baseline© model pear dynamometer
Measured: Change from base line and at the end of each of the six weeks
Quality of life according to Short- Form 36 Questionnaire (SF - 36)
SF - 36 is an instrument to asses health - related quality of life, this evaluates eight spheres (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) scored from zero to 100, where 100 is equivalent to no disability and zero is equivalent to maximum disability.
Measured: Change from base line and at the end of each of the six weeks
Assessment of exercise capacity
Exercise capacity will be measured with a six-minute walking test (6MWT), a sub-maximal exercise test which consists of the patient walking for six minutes along a 30 - meter corridor with two cones marking the distance to be covered while being given a series of cues.
Measured: Change from base line and at the end of each of the six weeks
COPD Assessment Test (CAT)
CAT is an eight item questionnaire to assess: cough, sputum, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep and energy scored from zero to 4 in each item, zero corresponds to the least affected and 5 to the most affected
Measured: Change from base line and at the end of each of the six weeks
Secondary outcomes (5)
Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)
This scale assess dyspnea in activities of daily living scored from 0 (absence of dyspnea during intense exercise) to 4 (dyspnea prevents the patient from leaving the house or appears with tasks such as dressing or undressing)
Measured: Change from base line and at the end of each of the six weeks
Assessment of perceived pain
The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies.
Measured: Change from base line and at the end of each of the six weeks
STAI (State-Trait Anxiety)
Questionnaire composed of 20 items with 4 points each that evaluate "state anxiety" (transitory emotional condition influenced by environmental factors that decrease or increase anxiety) and another 20 that evaluate "trait anxiety" (personality factor that predisposes to suffer or not suffer anxiety). The 2-part score ranks patients at a percentile to the general population. The higher the score, the greater the anxiety. It is one of the most widely used tools in research to measure levels of general anxiety.
Measured: Change from base line and at the end of each of the six weeks
TSK (Tampa Scale for Kinesiophobia)
7 items, 4 points each where higher scores indicate higher levels of fear of movement.
Measured: Change from base line and at the end of each of the six weeks
Beck II (Depression)
A 21-item scale used to assess the severity of depression. The patient has to select for each item the response alternative that best reflects his/her state during the last week. The total score is obtained by adding up the values of the selected items, which range from 0 to 3. The commonly accepted cut-off points for grading intensity/severity are as follows: 0 to 9, no depression; 10 to 18, mild depression; 19 to 29, moderate depression, and ≥ 30 points, severe depression.
Measured: Change from base line and at the end of each of the six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start20 Mar 2023
- Primary completion20 Dec 2023
- Study completion20 Sep 2024
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 TelemedicineStudies of the same condition, open and under way.
- 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
- A randomized clinical trial will be conducted between March 2023 and November 2024 in 62 male and female patients impacted by post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleuterio Atanasio Sánchez Romero, Universidad Europea de Madrid
- Investigators
- Jorge Hugo Villafañe, PhD, Study chair, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516836
- Sponsor's protocol ID
- Addressing post-COVID-19
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Romero EA, Garcia-Barredo-Restegui T, Martinez-Rolando L, Villafane JH, Galan-Fraguas A, Jurado-Molina R, Cuenca-Zaldivar JN, Soto-Goni XA, Martinez-Lozano P. Addressing post-COVID-19 musculoskeletal symptoms through pulmonary rehabilitation with an evidence-based eHealth education tool: Preliminary results from a pilot randomized controlled clinical trial. Medicine (Baltimore). 2025 Mar 7;104(10):e41583. doi: 10.1097/MD.0000000000041583.
PubMed 40068080
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine
- ClinicalTrials.gov ID
- NCT05516836
- Acronym / sponsor ID
- Addressing post-COVID-19
- Conditions
- Telemedicine, Musculoskeletal Disease, SARS-CoV-2, Pain, COVID-19, Exercise
- Keywords
- Telemedicine, SARS-CoV-2, Rehabilitation, Therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 26 Aug 2022 (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 purpose of the study will be to evaluate the effect of a rehabilitation program on the improvement of patients with post-COVID-19 musculoskeletal symptoms, as well as to quantify the impact of telemedicine that evaluates the evolution of pain, functionality, and quality of life.
Detailed description
A randomized clinical trial will be conducted in 100 patients with post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions. Data will be collected on the improvement of functional capacity and quality of life, in addition to assessing the evolution of musculoskeletal symptomatology, as well as pain and psychological variables. The telemedicine sessions will improve user adherence and follow-up, and the results are expected to be disseminated to the scientific community during and after the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be conducted between March 2023 and November 2024 in 62 male and female patients impacted by post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise program + Telemedicine | Experimental | Other: Multicomponent exercise program, Other: Tele-health primary care rehabilitation programThe multicomponent exercise program lasted 6 weeks with sessions twice a week for a total of 12 sessions. It will have a duration of forty minutes in which the first five and the last five will be performed at a constant load of 5% of its maximum load corresponding to the "warm-up" and "return to calm". Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed. A once a week telemedicine session will be carried out with the case group only before the face-to-face sessions, consisting of education, respiratory exercise, mobility and stretching, giving them a place to provide feedback and re-evaluate patients mid-treatment and will be aimed at assessing improvement and improving therapeutic adherence |
| Multicomponent exercise program | Active comparator | Other: Multicomponent exercise programThe multicomponent exercise program lasted 6 weeks with sessions twice a week for a total of 12 sessions. It will have a duration of forty minutes in which the first five and the last five will be performed at a constant load of 5% of its maximum load corresponding to the "warm-up" and "return to calm". Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Need to be post-COVID-19 patients (ICU or non-ICU)
- Musculoskeletal symptoms
- Be of adult age (over 18 years)
Key exclusion criteria (15 listed)
- Myocardial infarction
- Uncontrolled arrhythmia
- Recent pulmonary thromboembolism
- Terminal illness
- Patients undergoing lower limb unloading
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 |
|---|---|---|
| Multicomponent exercise programEach exercise session will have a duration of forty minutes in which the thirty minutes of intervallic work will be distributed as follows: twenty seconds until reaching 60% of their maximum load in the first seven sessions, adding five watts each day until reaching 80% of their maximum load in the fourteen sessions and seventy seconds of rest at 20% of their maximum load. At the end of the sessions, strengthening exercises will be performed with elastic bands, adapting their resistance according to the characteristics of the patients, of the lower limbs and of the upper limbs. Individualized respiratory physiotherapy exercises (diaphragmatic stimulation, positive expiratory pressure exercises, alveolar retraining and strengthening of the inspiratory musculature) will also be performed. | Other | Multicomponent exercise program, Multicomponent exercise program + Telemedicine |
| Tele-health primary care rehabilitation programA once a week telemedicine session will be carried out with the case group only before the face-to-face sessions, consisting of education, respiratory exercise, mobility and stretching, giving them a place to provide feedback and re-evaluate patients mid-treatment and will be aimed at assessing improvement and improving therapeutic adherence. | Other | Multicomponent exercise program + Telemedicine |
Primary outcome
Manual grip strength
Time frame: Change from base line and at the end of each of the six weeks
Grip strength will be measured in the affected hand and in the healthy hand (measuring the maximum grip strength). For this measurement, Handgrip strength averaging the result of three attempts with the dominant hand using a Baseline© model pear dynamometer
Quality of life according to Short- Form 36 Questionnaire (SF - 36)
Time frame: Change from base line and at the end of each of the six weeks
SF - 36 is an instrument to asses health - related quality of life, this evaluates eight spheres (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) scored from zero to 100, where 100 is equivalent to no disability and zero is equivalent to maximum disability.
Assessment of exercise capacity
Time frame: Change from base line and at the end of each of the six weeks
Exercise capacity will be measured with a six-minute walking test (6MWT), a sub-maximal exercise test which consists of the patient walking for six minutes along a 30 - meter corridor with two cones marking the distance to be covered while being given a series of cues.
COPD Assessment Test (CAT)
Time frame: Change from base line and at the end of each of the six weeks
CAT is an eight item questionnaire to assess: cough, sputum, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep and energy scored from zero to 4 in each item, zero corresponds to the least affected and 5 to the most affected
5 secondary outcomes
Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)
Time frame: Change from base line and at the end of each of the six weeks
Assessment of perceived pain
Time frame: Change from base line and at the end of each of the six weeks
STAI (State-Trait Anxiety)
Time frame: Change from base line and at the end of each of the six weeks
TSK (Tampa Scale for Kinesiophobia)
Time frame: Change from base line and at the end of each of the six weeks
Beck II (Depression)
Time frame: Change from base line and at the end of each of the six 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 27 Jan 2025.
- Derived from this study: PubMed 40068080Sanchez-Romero EA, Garcia-Barredo-Restegui T, Martinez-Rolando L, Villafane JH, Galan-Fraguas A, Jurado-Molina R, Cuenca-Zaldivar JN, Soto-Goni XA, Martinez-Lozano P. Addressing post-COVID-19 musculoskeletal symptoms through pulmonary rehabilitation with an evidence-based eHealth education tool: Preliminary results from a pilot randomized controlled clinical trial. Medicine (Baltimore). 2025 Mar 7;104(10):e41583. doi: 10.1097/MD.0000000000041583.
- 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.
Jorge Hugo Villafañe, PhD study chair
IRCCS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise program and Tele-health primary care rehabilitation program in people with Telemedicine and Musculoskeletal Disease, run by Universidad Europea 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 3 inclusion and 15 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 27 Jan 2025. 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?
Manual grip strength (time frame: Change from base line and at the end of each of the six weeks). 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 NCT05516836, 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 27 Jan 2025.