Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID

NCT ID: NCT06142240

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-09-01

Brief Summary

Symptoms of long-standing sequelae and complications of COVID-19, termed Long COVID19 or persistent COVID, have been reported worldwide. However, the etiology underlying the prolonged or fluctuating symptomatology is limited and there is no uniform and widely accepted definition.Patients describe persistent COVID as a fluctuating disease with variable and persistent symptoms.Most of the effects correspond to clinical symptoms such as fatigue, headache, arthralgias, hyposmia, gustatory sensations, etc. Fatigue is the most common and prolonged symptom of persistent COVID. Knowledge of the pathophysiological mechanisms of fatigue in COVID-19 disease, as well as the therapeutic approach, remains limited due to the relatively recent onset of this pathology. In particular, muscle strength training has been shown to improve muscle function and fatigue, not only during treatment, but also at long-term follow-up.

Detailed Description

Objective: To evaluate the effects on the perception of fatigue in patients with persistent COVID, who undergo a supervised and directed therapeutic exercise program in a health center compared to a home therapeutic exercise program.

Methods: Randomized pilot study. Subjects who are included in the study will perform a therapeutic exercise program which will last 8 weeks and 2 sessions per week of 1h duration. The participants assigned to the supervised group will carry out the program at the health center, while the participants assigned to the home group will receive telematic supervision (by videoconference). Both groups will be under the supervision of the assigned physiotherapist.

The components that will form part of the exercise program will be: muscular strength training and continuous-variable aerobic training or HIIT type with loads between 70-90% of maximum heart rate. The main variables are fatigue.

Conditions

Persistent COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

programe at the health centre

Subjects who are included in the study will perform a therapeutic exercise programme which will have a duration of 8 weeks and 2 sessions per week of 1h duration. Participants assigned to the supervised group will perform the programme at the health centre

Group Type: ACTIVE_COMPARATOR

exercise programe

Intervention Type: OTHER

The components of the exercise programe will be: muscle strength training and continuous-variable aerobic training or HIIT with loads between 70-90% of maximum heart rate. The aerobic training will last about 30 minutes and will then be completed with muscle training of the upper and lower limbs with loads determined according to the perception of effort (loads around 50-70%). The sessions will be monitored with pulse oximetry (heart rate and oxygen saturation), perception of fatigue and sensation of suffocation (Borg scale). The intensity of each component of the programme will be individualised according to the conditions of each subject.

Adherence to the programme will be recorded as successful when participation in the sessions is greater than 80% of the total number of sessions.

programe at the health home

Subjects who are included in the study will perform a therapeutic exercise programme which will have a duration of 8 weeks and 2 sessions per week of 1h duration. Participants assigned to the to the home group will receive telematic supervision (via videoconference).

Group Type: EXPERIMENTAL

exercise programe

Intervention Type: OTHER

The components of the exercise programe will be: muscle strength training and continuous-variable aerobic training or HIIT with loads between 70-90% of maximum heart rate. The aerobic training will last about 30 minutes and will then be completed with muscle training of the upper and lower limbs with loads determined according to the perception of effort (loads around 50-70%). The sessions will be monitored with pulse oximetry (heart rate and oxygen saturation), perception of fatigue and sensation of suffocation (Borg scale). The intensity of each component of the programme will be individualised according to the conditions of each subject.

Adherence to the programme will be recorded as successful when participation in the sessions is greater than 80% of the total number of sessions.

Interventions

exercise programe

The components of the exercise programe will be: muscle strength training and continuous-variable aerobic training or HIIT with loads between 70-90% of maximum heart rate. The aerobic training will last about 30 minutes and will then be completed with muscle training of the upper and lower limbs with loads determined according to the perception of effort (loads around 50-70%). The sessions will be monitored with pulse oximetry (heart rate and oxygen saturation), perception of fatigue and sensation of suffocation (Borg scale). The intensity of each component of the programme will be individualised according to the conditions of each subject.

Adherence to the programme will be recorded as successful when participation in the sessions is greater than 80% of the total number of sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients diagnosed with LongCOVID19 or persistent COVID19.
• Agree to participate and sign the informed consent form.

Exclusion Criteria

• Patients with comorbidities associated with having fatigue (e.g. cancer survivors, severe cardiovascular or respiratory disease prior to persistent COVID).
• Taking medication of drugs that may interfere with the perception of fatigue.
• Patients with mental disorders or cognitive impairment prior to persistent COVID.
• Patients who regularly practice intense sports (>4h/week).
• Any illness that may condition understanding and compliance with the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Facultat de ciencies de la Salut Universitat Ramon Llull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CSSV-Rif

Barcelona, Vilafranca Del Penedés, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Pedro Victor López Plaza

Role: CONTACT

pedrovictorlp@blanquerna.url.edu

932 53 32 56

Victoria Alcaraz Serrano

Role: CONTACT

victoriaas@blanquerna.url.edu

932 53 32 56

Facility Contacts

Victoria Alcaraz

Role: primary

938 90 51 36

Other Identifiers

2023-04-02

Identifier Type: -

Identifier Source: org_study_id