Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly

August 3, 2024 updated by: Jociane Schardong, Federal University of Health Science of Porto Alegre

Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial

Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. The primary outcomes of this study are functional mobility (Timed Up and Go test) and quality of life (EQ-5D questionnaire). Functional mobility will be assessed at baseline, after 4 and 8 weeks of treatment or follow-up. Quality of life will be assessed only at the beginning and end of 8 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. Rehabilitation strategies similar to conventional exercise that minimize the damage caused by aging and improve subjects' adherence need to be studied. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. Simultaneously with the WBS, the elderly will perform exercises for the upper, lower limbs and trunk. The following assessments will be carried out at baseline and 8 weeks to verify the effect of therapy: assessment of functional mobility; quality of life (EQ-5D); isometric muscle strength of the quadriceps muscles, biceps brachii and handgrip strength; lower limb muscle strength; assessment of body composition; assessment of cellular senescence; the inflammatory profile; well-being; measurement of muscle damage and pain; assessment of therapy safety and assessment of sleep quality. Assessments of functional mobility, lower limb muscle strength, cellular senescence; the inflammatory profile; well-being; and muscle damage will also be carried out in 4 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elderly people aged between 60 and 85 years;
  • Both sexes;
  • To have the ability to walk.

Exclusion Criteria:

  • Cognitive dysfunction;
  • Intolerance to electrical stimulator and/or changes in skin sensitivity;
  • Skin injuries or burns where the electrodes are positioned;
  • Sequelae of stroke;
  • Recent acute myocardial infarction;
  • Uncontrolled hypertension;
  • Grade IV heart failure or decompensated;
  • Unstable angina or arrhythmia;
  • Peripheral vascular changes in the lower limbs such as venous thrombosis deep;
  • Disabling osteoarticular or musculoskeletal disease;
  • Uncontrolled diabetes;
  • Cancer;
  • Autoimmune disease;
  • Pacemaker;
  • Epilepsy;
  • Hemophilia;
  • Chronic obstructive pulmonary disease;
  • Liver and kidney diseases;
  • Grade II obesity (BMI≥35).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
This group will receive whole-body electrical stimulation associated with exercises for upper, lower limbs and trunk for twice a week, for eight weeks, totaling 16 sessions.
Other: Whole-body electrical stimulation

The parameters adopted for the treated group will be: symmetrical biphasic current, pulse width of 400 µs, frequency of 80 Hz, contraction time of five seconds and decreasing rest time, varying from 10 to 5 s. The intensity will be individually adjusted to the patient's maximum tolerance limit to produce visible muscle contraction.

The session time will be 15 to 20 minutes and the number of contractions will increase with each week of training.

Concomitant to the electrical stimuli, exercises will be performed for the elbow flexors and extensors, spine flexors and extensors, knee flexors and extensors, hip flexors and extensors and the calf muscles.

Other Names:
  • Whole-body electromyostimulation
No Intervention: Control
This group will not receive any type of electrical stimulation or exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional mobility.
Time Frame: Baseline, after 4 and 8 weeks.
Functional mobility will be assessed using the "Timed Up and Go" test.
Baseline, after 4 and 8 weeks.
Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D).
Time Frame: Baseline and after 8 weeks.
Change in quality of life will be assessed by the EuroQol five-dimensional questionnaire (EQ-5D). The final score of this questionnaire can vary from 0 to 1. The closer to 1, the better the subject's quality of life.
Baseline and after 8 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isometric muscle strength of the quadriceps muscle.
Time Frame: Baseline and after 8 weeks.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Baseline and after 8 weeks.
Isometric muscle strength of the biceps brachii.
Time Frame: Baseline and after 8 weeks.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Baseline and after 8 weeks.
Isometric handgrip strength.
Time Frame: Baseline and after 8 weeks.
Isometric handgrip strength will be assessed by dynamometry.
Baseline and after 8 weeks.
Lower limb muscle strength.
Time Frame: Baseline, after 4 and 8 weeks.
Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).
Baseline, after 4 and 8 weeks.
Body composition.
Time Frame: Baseline and after 8 weeks.
Body composition will be assessed by bioimpedance.
Baseline and after 8 weeks.
Cellular senescence.
Time Frame: Baseline, after 4 and 8 weeks.
Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.
Baseline, after 4 and 8 weeks.
Inflammatory profile.
Time Frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring interleukin 6 by ELISA.
Baseline, after 4 and 8 weeks.
Inflammatory profile.
Time Frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring interleukin 10 by ELISA.
Baseline, after 4 and 8 weeks.
Well-being.
Time Frame: Baseline, after 4 and 8 weeks.
Well-being will be assessed by measuring beta-endorphin by ELISA.
Baseline, after 4 and 8 weeks.
Muscle damage.
Time Frame: Baseline, after 4 and 8 weeks.
Muscle damage will be assessed by creatine kinase dosage.
Baseline, after 4 and 8 weeks.
Sleep quality.
Time Frame: Baseline and after 8 weeks.
Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Baseline and after 8 weeks.
Inflammatory profile.
Time Frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring tumor necrosis factor alpha by ELISA.
Baseline, after 4 and 8 weeks.
Muscle pain measured by analogic visual scale (AVS).
Time Frame: Baseline and after 8 weeks.
Muscle pain will be assessed by analogic visual scale (AVS). This scale ranges from 0 to 10. The closer to 10, the greater the subject's pain.
Baseline and after 8 weeks.
Change in heart rate.
Time Frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring heart rate by pulse oximetry.
Baseline and after 20 minutes of whole-body electrical stimulation.
Change in peripheral oxygen saturation.
Time Frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring peripheral oxygen saturation by pulse oximetry.
Baseline and after 20 minutes of whole-body electrical stimulation.
Change in systolic blood pressure.
Time Frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring systolic blood pressure by sphygmomanometer.
Baseline and after 20 minutes of whole-body electrical stimulation.
Change in diastolic blood pressure.
Time Frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.
Baseline and after 20 minutes of whole-body electrical stimulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leonhardt Ventures LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BS_Eldery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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