Addressing Post-COVID-19 Musculoskeletal Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Pain; Exercise; Telemedicine; SARS-CoV-2; Musculoskeletal Disease
• Intervention / Treatment: Other: Multicomponent exercise program; Other: Tele-health primary care rehabilitation program

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleuterio A. Sánchez Romero, PhD; Phone Number: +34 617123563; Email: eleuterio.sanchez@universidadeuropea.es
• Study Contact Backup: Name: Lidia Martínez Rolando, MSc; Phone Number: +34 689895710; Email: lidiamrfisioterapia@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28014
    • Recruiting
    • Eleuterio A. Sánchez Romero
    • Contact: Eleuterio A. Sánchez Romero; Phone Number: 617123563; Email: elusanchezromero@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent exercise program + Telemedicine; 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	Other: Multicomponent exercise program; 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.; Other: Tele-health primary care rehabilitation program; 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.
Active Comparator: Multicomponent exercise program; 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.	Other: Multicomponent exercise program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	Change from base line and at the end of each of the six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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.	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.	Change from base line and at the end of each of the six weeks

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Study Chair: Jorge Hugo Villafañe, PhD, IRCCS Fondazione Don Carlo Gnocchi

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; SARS-CoV-2; Telemedicine; Therapeutic exercise
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Musculoskeletal Diseases
• Other Study ID Numbers: Addressing post-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No