Clinical trial NCT06131671: Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly
Official title: Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Aged
Electric stimulation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Leonhardt Ventures LLC
First posted: 2023-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Functional mobility.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D).
timeFrame: Baseline and after 8 weeks.
Secondary outcomes:
measure: Isometric muscle strength of the quadriceps muscle.
timeFrame: Baseline and after 8 weeks.
measure: Isometric muscle strength of the biceps brachii.
timeFrame: Baseline and after 8 weeks.
measure: Isometric handgrip strength.
timeFrame: Baseline and after 8 weeks.
measure: Lower limb muscle strength.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Body composition.
timeFrame: Baseline and after 8 weeks.
measure: Cellular senescence.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Inflammatory profile.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Inflammatory profile.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Inflammatory profile.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Well-being.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Muscle damage.
timeFrame: Baseline, after 4 and 8 weeks.
measure: Muscle pain measured by analogic visual scale (AVS).
timeFrame: Baseline and after 8 weeks.
measure: Sleep quality.
timeFrame: Baseline and after 8 weeks.
measure: Change in heart rate.
timeFrame: Baseline and after 20 minutes of whole-body electrical stimulation.
measure: Change in peripheral oxygen saturation.
timeFrame: Baseline and after 20 minutes of whole-body electrical stimulation.
measure: Change in systolic blood pressure.
timeFrame: Baseline and after 20 minutes of whole-body electrical stimulation.
measure: Change in diastolic blood pressure.
timeFrame: Baseline and after 20 minutes of whole-body electrical stimulation.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References: