Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly
- Conditions
- Aged
- Interventions
- Other: Whole-body electrical stimulation
- Registration Number
- NCT06131671
- Lead Sponsor
- Federal University of Health Science of Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Elderly people aged between 60 and 85 years;
- Both sexes;
- To have the ability to walk.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Whole-body electrical stimulation 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.
- Primary Outcome Measures
Name Time Method Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D). 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.
Functional mobility. Baseline, after 4 and 8 weeks. Functional mobility will be assessed using the "Timed Up and Go" test.
- Secondary Outcome Measures
Name Time Method Inflammatory profile. Baseline, after 4 and 8 weeks. Inflammatory profile will be assessed by measuring tumor necrosis factor alpha by ELISA.
Sleep quality. Baseline and after 8 weeks. Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Isometric muscle strength of the biceps brachii. Baseline and after 8 weeks. Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Well-being. Baseline, after 4 and 8 weeks. Well-being will be assessed by measuring beta-endorphin by ELISA.
Muscle pain measured by analogic visual scale (AVS). 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.
Change in diastolic blood pressure. Baseline and after 20 minutes of whole-body electrical stimulation. Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.
Muscle damage. Baseline, after 4 and 8 weeks. Muscle damage will be assessed by creatine kinase dosage.
Isometric muscle strength of the quadriceps muscle. Baseline and after 8 weeks. Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Isometric handgrip strength. Baseline and after 8 weeks. Isometric handgrip strength will be assessed by dynamometry.
Cellular senescence. Baseline, after 4 and 8 weeks. Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.
Change in heart rate. Baseline and after 20 minutes of whole-body electrical stimulation. Safety will be assessed by monitoring heart rate by pulse oximetry.
Change in peripheral oxygen saturation. Baseline and after 20 minutes of whole-body electrical stimulation. Safety will be assessed by monitoring peripheral oxygen saturation by pulse oximetry.
Lower limb muscle strength. Baseline, after 4 and 8 weeks. Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).
Body composition. Baseline and after 8 weeks. Body composition will be assessed by bioimpedance.
Change in systolic blood pressure. Baseline and after 20 minutes of whole-body electrical stimulation. Safety will be assessed by monitoring systolic blood pressure by sphygmomanometer.
Trial Locations
- Locations (1)
Federal University of Health Sciences of Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil