Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
NCT Number: NCT06131671
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.
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Notify Me60 year–85 year
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, after 4 and 8 weeks.
Functional mobility will be assessed using the "Timed Up and Go" test.
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.
Time frame: Baseline and after 8 weeks.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Time frame: Baseline and after 8 weeks.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Time frame: Baseline and after 8 weeks.
Isometric handgrip strength will be assessed by dynamometry.
Time frame: Baseline, after 4 and 8 weeks.
Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).
Time frame: Baseline and after 8 weeks.
Body composition will be assessed by bioimpedance.
Time frame: Baseline, after 4 and 8 weeks.
Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring interleukin 6 by ELISA.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring interleukin 10 by ELISA.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile will be assessed by measuring tumor necrosis factor alpha by ELISA.
Time frame: Baseline, after 4 and 8 weeks.
Well-being will be assessed by measuring beta-endorphin by ELISA.
Time frame: Baseline, after 4 and 8 weeks.
Muscle damage will be assessed by creatine kinase dosage.
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.
Time frame: Baseline and after 8 weeks.
Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring heart rate by pulse oximetry.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring peripheral oxygen saturation by pulse oximetry.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring systolic blood pressure by sphygmomanometer.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.
Federal University of Health Science of Porto Alegre
Other
Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial
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