Addressing Post-COVID-19 Musculoskeletal Symptoms

NCT05516836 | Completed

• 1 other identifier: Addressing post-COVID-19
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Telemedicine; Musculoskeletal Disease; SARS-CoV-2; Pain; COVID-19; Exercise

Keywords

Telemedicine; SARS-CoV-2; Rehabilitation; Therapeutic exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Dyspnea using the modified Medical Research Council dyspnea scale (mMRC)

  Change from base line and at the end of each of the six weeks

• Assessment of perceived pain

  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

• Beck II (Depression)

  Change from base line and at the end of each of the six weeks

Study Arms (2)

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

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.

Other: Multicomponent exercise program

Interventions

Multicomponent exercise program OTHER

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.

Multicomponent exercise program; Multicomponent exercise program + Telemedicine

Tele-health primary care rehabilitation program OTHER

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 + Telemedicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Eleuterio A. Sánchez Romero

Madrid, 28014, Spain

Location

Related Publications (1)

• 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.

  PMID: 40068080 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Pain; COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Jorge Hugo Villafañe, PhD

  IRCCS Fondazione Don Carlo Gnocchi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 26, 2022
• Study Start: March 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: September 20, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)