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

NCT06131671 | Completed DMC

• 1 other identifier: BS_Eldery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aged

Keywords

Aged; Electric stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Isometric muscle strength of the quadriceps muscle.

  Baseline and after 8 weeks.

• Isometric muscle strength of the biceps brachii.

  Baseline and after 8 weeks.

• Isometric handgrip strength.

  Baseline and after 8 weeks.

• Lower limb muscle strength.

  Baseline, after 4 and 8 weeks.

• Body composition.

  Baseline and after 8 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

This group will not receive any type of electrical stimulation or exercise.

Interventions

Whole-body electrical stimulation OTHER

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.

Also known as: Whole-body electromyostimulation

Intervention

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Leonhardt Ventures LLC: collaborator

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: January 22, 2024
• Primary Completion: March 22, 2024
• Study Completion: April 15, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)