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Addressing Post-COVID-19 Musculoskeletal Symptoms

Primary Purpose

Telemedicine, Musculoskeletal Disease, SARS-CoV-2

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent exercise program
Tele-health primary care rehabilitation program
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telemedicine focused on measuring Telemedicine, SARS-CoV-2, Rehabilitation, Therapeutic exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Need to be post-COVID-19 patients (ICU or non-ICU)
  • Musculoskeletal symptoms
  • Be of adult age (over 18 years)

Exclusion Criteria:

  • Myocardial infarction
  • Uncontrolled arrhythmia
  • Recent pulmonary thromboembolism
  • Terminal illness
  • Patients undergoing lower limb unloading
  • Lower or upper limb fractures in the last three months
  • 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

Sites / Locations

  • Eleuterio A. Sánchez RomeroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multicomponent exercise program + Telemedicine

Multicomponent exercise program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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.
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.
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

Secondary Outcome Measures

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)
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.
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.
TSK (Tampa Scale for Kinesiophobia)
7 items, 4 points each where higher scores indicate higher levels of fear of movement.
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.

Full Information

First Posted
August 21, 2022
Last Updated
May 8, 2023
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05516836
Brief Title
Addressing Post-COVID-19 Musculoskeletal Symptoms
Official Title
Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
A non-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Musculoskeletal Disease, SARS-CoV-2, Pain, COVID-19, Exercise
Keywords
Telemedicine, SARS-CoV-2, Rehabilitation, Therapeutic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A non-randomized clinical trial will be conducted between June 2022 and February 2023 in 100 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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent exercise program + Telemedicine
Arm Type
Experimental
Arm Description
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
Arm Title
Multicomponent exercise program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multicomponent exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tele-health primary care rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Manual grip strength
Description
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
Time Frame
Change from base line and at the end of each of the six weeks
Title
Quality of life according to Short- Form 36 Questionnaire (SF - 36)
Description
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.
Time Frame
Change from base line and at the end of each of the six weeks
Title
Assessment of exercise capacity
Description
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.
Time Frame
Change from base line and at the end of each of the six weeks
Title
COPD Assessment Test (CAT)
Description
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
Time Frame
Change from base line and at the end of each of the six weeks
Secondary Outcome Measure Information:
Title
Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)
Description
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)
Time Frame
Change from base line and at the end of each of the six weeks
Title
Assessment of perceived pain
Description
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.
Time Frame
Change from base line and at the end of each of the six weeks
Title
STAI (State-Trait Anxiety)
Description
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.
Time Frame
Change from base line and at the end of each of the six weeks
Title
TSK (Tampa Scale for Kinesiophobia)
Description
7 items, 4 points each where higher scores indicate higher levels of fear of movement.
Time Frame
Change from base line and at the end of each of the six weeks
Title
Beck II (Depression)
Description
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.
Time Frame
Change from base line and at the end of each of the six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Need to be post-COVID-19 patients (ICU or non-ICU) Musculoskeletal symptoms Be of adult age (over 18 years) Exclusion Criteria: Myocardial infarction Uncontrolled arrhythmia Recent pulmonary thromboembolism Terminal illness Patients undergoing lower limb unloading Lower or upper limb fractures in the last three months 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleuterio A. Sánchez Romero, PhD
Phone
+34 617123563
Email
eleuterio.sanchez@universidadeuropea.es
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Martínez Rolando, MSc
Phone
+34 689895710
Email
lidiamrfisioterapia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Hugo Villafañe, PhD
Organizational Affiliation
IRCCS Fondazione Don Carlo Gnocchi
Official's Role
Study Chair
Facility Information:
Facility Name
Eleuterio A. Sánchez Romero
City
Madrid
ZIP/Postal Code
28014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleuterio A. Sánchez Romero
Phone
617123563
Email
elusanchezromero@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Addressing Post-COVID-19 Musculoskeletal Symptoms

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