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

Aged Clinical Trial

Official title:

Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131671
• Other study ID #: BS_Eldery
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: January 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 15, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aged

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Leonhardt Ventures LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional mobility.	Functional mobility will be assessed using the "Timed Up and Go" test.	Baseline, after 4 and 8 weeks.
Primary	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	Isometric muscle strength of the quadriceps muscle.	Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.	Baseline and after 8 weeks.
Secondary	Isometric muscle strength of the biceps brachii.	Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.	Baseline and after 8 weeks.
Secondary	Isometric handgrip strength.	Isometric handgrip strength will be assessed by dynamometry.	Baseline and after 8 weeks.
Secondary	Lower limb muscle strength.	Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).	Baseline, after 4 and 8 weeks.
Secondary	Body composition.	Body composition will be assessed by bioimpedance.	Baseline and after 8 weeks.
Secondary	Cellular senescence.	Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.	Baseline, after 4 and 8 weeks.
Secondary	Inflammatory profile.	Inflammatory profile will be assessed by measuring interleukin 6 by ELISA.	Baseline, after 4 and 8 weeks.
Secondary	Inflammatory profile.	Inflammatory profile will be assessed by measuring interleukin 10 by ELISA.	Baseline, after 4 and 8 weeks.
Secondary	Inflammatory profile.	Inflammatory profile will be assessed by measuring tumor necrosis factor alpha by ELISA.	Baseline, after 4 and 8 weeks.
Secondary	Well-being.	Well-being will be assessed by measuring beta-endorphin by ELISA.	Baseline, after 4 and 8 weeks.
Secondary	Muscle damage.	Muscle damage will be assessed by creatine kinase dosage.	Baseline, after 4 and 8 weeks.
Secondary	Muscle pain measured by analogic visual scale (AVS).	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.	Baseline and after 8 weeks.
Secondary	Sleep quality.	Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).	Baseline and after 8 weeks.
Secondary	Change in heart rate.	Safety will be assessed by monitoring heart rate by pulse oximetry.	Baseline and after 20 minutes of whole-body electrical stimulation.
Secondary	Change in peripheral oxygen saturation.	Safety will be assessed by monitoring peripheral oxygen saturation by pulse oximetry.	Baseline and after 20 minutes of whole-body electrical stimulation.
Secondary	Change in systolic blood pressure.	Safety will be assessed by monitoring systolic blood pressure by sphygmomanometer.	Baseline and after 20 minutes of whole-body electrical stimulation.
Secondary	Change in diastolic blood pressure.	Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.	Baseline and after 20 minutes of whole-body electrical stimulation.