Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID

Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID: Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent COVID-19
• Intervention / Treatment: Other: exercise programe

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Victor López Plaza; Phone Number: 932 53 32 56; Email: pedrovictorlp@blanquerna.url.edu
• Study Contact Backup: Name: Victoria Alcaraz Serrano; Phone Number: 932 53 32 56; Email: victoriaas@blanquerna.url.edu

Study Locations

• Spain
  • Vilafranca Del Penedés
    • Barcelona, Vilafranca Del Penedés, Spain, 08720
      • Recruiting
      • CSSV-Rif
      • Contact: Victoria Alcaraz; Phone Number: 938 90 51 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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.
Experimental: 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).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	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.	hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	Spirometry will be measured using an EasyOneTM World Spirometer (ndd Medical Technologies, Zurich, Switzerland).; Forced spirometry (FEV1, normal value 70-75% mesure Litres) percentage of the total exhaled volume in the first second; Forced vital capacity (FVC, normal value 80% mesure Litres ) It is made up of the sum of total volume, inspiratory reserve volume and expiratory reserve volume. The variables will be included in the analysis and will be performed following ATS/ERS recommendations (19).	hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2023-04-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No