Clinical trial NCT05516836: Addressing Post-COVID-19 Musculoskeletal Symptoms
Official title: Addressing Post-COVID-19 Musculoskeletal Symptoms Through Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Musculoskeletal Disease
SARS-CoV-2
Pain
COVID-19
Exercise
Keywords: Telemedicine
SARS-CoV-2
Rehabilitation
Therapeutic exercise
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Manual grip strength
timeFrame: Change from base line and at the end of each of the six weeks
measure: Quality of life according to Short- Form 36 Questionnaire (SF - 36)
timeFrame: Change from base line and at the end of each of the six weeks
measure: Assessment of exercise capacity
timeFrame: Change from base line and at the end of each of the six weeks
measure: COPD Assessment Test (CAT)
timeFrame: Change from base line and at the end of each of the six weeks
Secondary outcomes:
measure: Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)
timeFrame: Change from base line and at the end of each of the six weeks
measure: Assessment of perceived pain
timeFrame: Change from base line and at the end of each of the six weeks
measure: STAI (State-Trait Anxiety)
timeFrame: Change from base line and at the end of each of the six weeks
measure: TSK (Tampa Scale for Kinesiophobia)
timeFrame: Change from base line and at the end of each of the six weeks
measure: Beck II (Depression)
timeFrame: Change from base line and at the end of each of the six weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Eleuterio A. Sánchez Romero
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Jorge Hugo Villafañe, PhD
role: STUDY_CHAIR
References: