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

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: Completed
• Conditions: Aged
• Intervention / Treatment: Other: Whole-body electrical stimulation

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Functional mobility.	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).	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

Outcome Measure	Measure Description	Time Frame
Isometric muscle strength of the quadriceps muscle.	Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.	Baseline and after 8 weeks.
Isometric muscle strength of the biceps brachii.	Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.	Baseline and after 8 weeks.
Isometric handgrip strength.	Isometric handgrip strength will be assessed by dynamometry.	Baseline and after 8 weeks.
Lower limb muscle strength.	Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).	Baseline, after 4 and 8 weeks.
Body composition.	Body composition will be assessed by bioimpedance.	Baseline and after 8 weeks.
Cellular senescence.	Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.	Baseline, after 4 and 8 weeks.
Inflammatory profile.	Inflammatory profile will be assessed by measuring interleukin 6 by ELISA.	Baseline, after 4 and 8 weeks.
Inflammatory profile.	Inflammatory profile will be assessed by measuring interleukin 10 by ELISA.	Baseline, after 4 and 8 weeks.
Well-being.	Well-being will be assessed by measuring beta-endorphin by ELISA.	Baseline, after 4 and 8 weeks.
Muscle damage.	Muscle damage will be assessed by creatine kinase dosage.	Baseline, after 4 and 8 weeks.
Sleep quality.	Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).	Baseline and after 8 weeks.
Inflammatory profile.	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).	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.	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.	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.	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.	Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.	Baseline and after 20 minutes of whole-body electrical stimulation.

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Leonhardt Ventures LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Aged; Electric stimulation
• Other Study ID 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