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

NCT ID: NCT06131671

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2024-04-15

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.

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.

Conditions

Aged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Whole-body electrical stimulation

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Whole-body electromyostimulation

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leonhardt Ventures LLC

INDUSTRY

Sponsor Role: collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Jociane Schardong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

BS_Eldery

Identifier Type: -

Identifier Source: org_study_id