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Clinical Trials/NCT05516836
NCT05516836
Completed
Not Applicable

Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine

Universidad Europea de Madrid1 site in 1 country62 target enrollmentMarch 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Telemedicine
Sponsor
Universidad Europea de Madrid
Enrollment
62
Locations
1
Primary Endpoint
Manual grip strength
Status
Completed
Last Updated
last year

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
March 20, 2023
End Date
September 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Europea de Madrid
Responsible Party
Principal Investigator
Principal Investigator

Eleuterio Atanasio Sánchez Romero

Principal Investigator

Universidad Europea de Madrid

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

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

  • Assessment of perceived pain(Change from base line and at the end of each of the six weeks)
  • Beck II (Depression)(Change from base line and at the end of each of the six weeks)
  • STAI (State-Trait Anxiety)(Change from base line and at the end of each of the six weeks)
  • TSK (Tampa Scale for Kinesiophobia)(Change from base line and at the end of each of the six weeks)
  • Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)(Change from base line and at the end of each of the six weeks)

Study Sites (1)

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