Whole-Body Electrostimulation for Functional Recovery in Post-COVID Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidad Rey Juan Carlos

About this trial

Post-COVID syndrome is a condition that affects some people after recovering from the acute phase of COVID-19. Common symptoms include persistent fatigue, reduced physical capacity, and difficulties performing everyday activities, which can significantly impact quality of life and independence. At present, there is limited scientific evidence on effective rehabilitation strategies for this population.

The purpose of this study is to evaluate whether the use of a whole-body electrostimulation suit can improve fatigue, physical performance, and functional independence in people with post-COVID syndrome. Whole-body electrostimulation is a non-pharmacological technique that uses low-frequency electrical impulses to activate multiple muscle groups simultaneously and has shown potential benefits in other clinical populations.

This is a randomized, double-blind, controlled pilot clinical trial. Participants will be randomly assigned to either an experimental group, which will receive active whole-body electrostimulation during functional activities, or a control group, which will follow the same sessions using the electrostimulation suit with minimal stimulation (placebo condition). Neither participants nor outcome assessors will know which group each participant belongs to.

The intervention will consist of 12 supervised sessions conducted once per week. Outcomes will be assessed before and after the intervention, with an additional follow-up assessment three months later. The main outcomes include fatigue levels, functional capacity, physical performance, and independence in activities of daily living. Safety and tolerance to the intervention will be monitored throughout the study.

The results of this study may help to determine the feasibility and potential effectiveness of whole-body electrostimulation as a rehabilitation tool for people with post-COVID syndrome and provide preliminary data for future larger-scale clinical trials.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole-Body Electromyostimulation Suit

    Device

    The intervention consists of the use of a whole-body electromyostimulation (WB-EMS) suit with integrated surface electrodes designed to stimulate multiple large muscle groups simultaneously. Electrical stimulation is delivered at low-to-moderate frequencies and individualized intensities during supervised functional activities. Stimulation parameters are adjusted according to participant tolerance to achieve visible and tolerable muscle contractions. Sessions are conducted once per week for a total of 12 sessions, with progressive increases in session duration from 10 to 20 minutes. In the control condition, the same device is used with minimal, non-therapeutic electrical stimulation.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Active Whole-Body ElectrostimulationExperimental treatment 1 intervention
Group B: Sham Whole-Body ElectrostimulationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fatigue Severity

Fatigue will be assessed using the Chalder Fatigue Scale (CFQ-11), a validated self-report questionnaire that evaluates physical and mental fatigue. Higher scores indicate greater fatigue severity.

Time frame
Baseline, immediately post-intervention (12 weeks), and 3-month follow-up
2

Handgrip Muscle Strength

Handgrip strength will be measured using a hand-held dynamometer as an objective indicator of overall muscle strength. Measurements will be performed following standardized procedures.

Time frame
Baseline, immediately post-intervention (12 weeks), and 3-month follow-up

Secondary outcomes

1

Independence in Activities of Daily Living

Independence in activities of daily living will be assessed using the Activities of Daily Living Questionnaire (ADLQ), a self-report instrument that evaluates functional independence across daily activities. Lower scores indicate greater functional independence.

Time frame
Baseline, immediately post-intervention (12 weeks), and 3-month follow-up
2

Functional Capacity

Functional capacity will be evaluated using the Six-Minute Walk Test (6MWT), which measures the maximum distance walked in six minutes as an indicator of aerobic capacity and functional exercise tolerance.

Time frame
Baseline, immediately post-intervention (12 weeks), and 3-month follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: