Addressing Post-COVID-19 Musculoskeletal Symptoms

NCT ID: NCT05516836

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-09-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multicomponent exercise program

Intervention Type: 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.

Tele-health primary care rehabilitation program

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Multicomponent exercise program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Eleuterio Atanasio Sánchez Romero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge Hugo Villafañe, PhD

Role: STUDY_CHAIR

IRCCS Fondazione Don Carlo Gnocchi

Locations

Eleuterio A. Sánchez Romero

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 40068080 (View on PubMed)

Other Identifiers

Addressing post-COVID-19

Identifier Type: -

Identifier Source: org_study_id