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

NCT07312357 | Not Yet Recruiting

• 2 other identifiers: A620-WBEMS-POSTCOVIDA620
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Long Covid; Post COVID Syndrome Long Covid; Post COVID Syndrome; Long COVID Fatigue

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (2)

• Independence in Activities of Daily Living

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

• Functional Capacity

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

Study Arms (2)

Active Whole-Body Electrostimulation

EXPERIMENTAL

Participants in this arm will receive active whole-body electromyostimulation using an electrostimulation suit during supervised functional activities. The intervention will consist of 12 weekly sessions with individualized and progressive stimulation parameters adjusted to achieve visible and tolerable muscle contractions.

Device: Whole-Body Electromyostimulation Suit

Sham Whole-Body Electrostimulation

PLACEBO COMPARATOR

Participants in this arm will use the same whole-body electrostimulation suit and perform the same supervised functional activities as the experimental group. The electrical stimulation will be set at minimal, non-therapeutic levels to act as a placebo condition, without expected physiological effects.

Device: Whole-Body Electromyostimulation Suit

Interventions

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.

Active Whole-Body Electrostimulation; Sham Whole-Body Electrostimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of post-COVID syndrome (long COVID), with persistent symptoms following SARS-CoV-2 infection.
• Presence of fatigue and/or functional limitations associated with post-COVID syndrome.
• Ability to understand the study procedures and provide written informed consent.
• Ability to participate in the intervention and assessments according to the study protocol.

You may not qualify if:

• Participation in other structured physical exercise or rehabilitation programs during the study period.
• Presence of severe cardiovascular disease or uncontrolled medical conditions that contraindicate physical activity or electrostimulation.
• Neurological disorders or severe neuromuscular diseases.
• Use of anabolic drugs or medications that may interfere with muscle function.
• Pregnancy.
• Epilepsy.
• Active skin lesions or dermatological conditions in areas where electrodes are applied.
• Recent oncological surgery.
• Acute venous thrombosis.
• Presence of cardiac pacemakers or implanted electronic or conductive medical devices.
• Any clinical deterioration or condition that, in the opinion of the investigators, would make participation unsafe.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher, Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share