Clinical trial NCT06142240: Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID
Official title: Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent COVID-19
Lead sponsor: Facultat de ciencies de la Salut Universitat Ramon Llull
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fatigue
timeFrame: hour
Secondary outcomes:
measure: Exercise capacity
timeFrame: hour
Other outcomes:
measure: Pulmonary function
timeFrame: hour
Locations:
city: Barcelona
country: Spain
facility: CSSV-Rif
state: Vilafranca Del Penedés
Study officials:
References: