Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID

NCT06142240 | Unknown

• 1 other identifier: 2023-04-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent COVID-19

Outcome Measures

Primary Outcomes (1)

• Fatigue

  this is the main variable of the study. It will be measured using the self-report scale "Fatigue Impact Scale" (FIS) (Fisk et al., 1994), which assesses the perception of functional limitation caused by fatigue in three areas: physical, cognitive and psychosocial. Range 0 (no problem) to 4 (extrem problem)

  hour

Secondary Outcomes (1)

• Exercise capacity

  hour

Other Outcomes (1)

• Pulmonary function

  hour

Study Arms (2)

programe at the health centre

ACTIVE COMPARATOR

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

Other: exercise programe

programe at the health home

EXPERIMENTAL

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).

Other: exercise programe

Interventions

exercise programe 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 centre; programe at the health home

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Facultat de ciencies de la Salut Universitat Ramon Llull: lead

Study Sites (1)

CSSV-Rif

Barcelona, Vilafranca Del Penedés, 08720, Spain

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pedro Victor López Plaza

CONTACT

932 53 32 56; pedrovictorlp@blanquerna.url.edu

Victoria Alcaraz Serrano

CONTACT

932 53 32 56; victoriaas@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design: Interventional study. The study will be carried out at the Ricard i Fortuny Social and Health Centre (CSSV RiF) in Vilafranca del Penedès (Barcelona).

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 21, 2023
• Study Start: June 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

ES (1)