Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID

Not Applicable

Recruiting

• Conditions: Persistent COVID-19
• Interventions: Other: exercise programe

• Registration Number: NCT06142240
• Lead Sponsor: Facultat de ciencies de la Salut Universitat Ramon Llull

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-04-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
programe at the health centre	exercise programe	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
programe at the health home	exercise programe	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).

Primary Outcome Measures

Name	Time	Method
Fatigue	hour	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)

Secondary Outcome Measures

Name	Time	Method
Exercise capacity	hour	will be assessed using the six-minute walk test (6MWT). In the 6MWT we will measure the total number of metres the patient is able to walk for 6 minutes. The test will be performed in an indoor corridor of 30m distance, repeated 2 times with a pause of at least 30min between them.

Trial Locations

Locations (1)

CSSV-Rif; 🇪🇸 Barcelona, Vilafranca Del Penedés, Spain