AgedNCT06131671

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

A study testing Whole-body electrical stimulation in people with Aged, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Aged
What is being tested?: Whole-body electrical stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteBrazil
Study dates: 22 Jan 2024to 15 Apr 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Elderly people aged between 60 and 85 years;
Both sexes;
To have the ability to walk.

Who cannot join

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;

Show all 19Show fewer

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).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170

Other trials in Brazil

About this study

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

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.

Read the 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
Being tested: Whole-body electrical stimulation
Keywords: Aged, Electric stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whole-body electrical stimulationOther
Also called Whole-body electromyostimulation
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.

Study groups in NCT06131671
Study group	Role	What they receive
Intervention	Experimental	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. Receives: Other: Whole-body electrical stimulation
Control	No intervention	This group will not receive any type of electrical stimulation or exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional mobility.
Functional mobility will be assessed using the "Timed Up and Go" test.
Measured: Baseline, after 4 and 8 weeks.
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.
Measured: Baseline and after 8 weeks.

Secondary outcomes (17)

Isometric muscle strength of the quadriceps muscle.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Measured: Baseline and after 8 weeks.
Isometric muscle strength of the biceps brachii.
Isometric muscle strength of the quadriceps muscle will be assessed by dynamometry.
Measured: Baseline and after 8 weeks.
Isometric handgrip strength.
Isometric handgrip strength will be assessed by dynamometry.
Measured: Baseline and after 8 weeks.
Lower limb muscle strength.
Lower limb muscle strength will be assessed by the 10-repetition sit-stand test (SST10).
Measured: Baseline, after 4 and 8 weeks.
Body composition.
Body composition will be assessed by bioimpedance.
Measured: Baseline and after 8 weeks.
Cellular senescence.
Cellular senescence will be assessed by measuring alpha-klotho protein by ELISA.
Measured: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Inflammatory profile will be assessed by measuring interleukin 6 by ELISA.
Measured: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Inflammatory profile will be assessed by measuring interleukin 10 by ELISA.
Measured: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Inflammatory profile will be assessed by measuring tumor necrosis factor alpha by ELISA.
Measured: Baseline, after 4 and 8 weeks.
Well-being.
Well-being will be assessed by measuring beta-endorphin by ELISA.
Measured: Baseline, after 4 and 8 weeks.
Muscle damage.
Muscle damage will be assessed by creatine kinase dosage.
Measured: Baseline, after 4 and 8 weeks.
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.
Measured: Baseline and after 8 weeks.
Sleep quality.
Sleep quality will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline and after 8 weeks.
Change in heart rate.
Safety will be assessed by monitoring heart rate by pulse oximetry.
Measured: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in peripheral oxygen saturation.
Safety will be assessed by monitoring peripheral oxygen saturation by pulse oximetry.
Measured: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in systolic blood pressure.
Safety will be assessed by monitoring systolic blood pressure by sphygmomanometer.
Measured: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in diastolic blood pressure.
Safety will be assessed by monitoring diastolic blood pressure by sphygmomanometer.
Measured: Baseline and after 20 minutes of whole-body electrical stimulation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202415 Apr 2024

First posted14 Nov 2023
Study start22 Jan 2024
Primary completion22 Mar 2024
Study completion15 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AgedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06131671
Sponsor's protocol ID: BS_Eldery
Status last verified: Aug 2024
First submitted: 9 Nov 2023
Last updated: 6 Aug 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06131671
Acronym / sponsor ID: BS_Eldery
Conditions: Aged
Keywords: Aged, Electric stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Federal University of Health Science of Porto AlegreUniversity, hospital or other
Collaborators: Leonhardt Ventures LLC
Study start: 22 Jan 2024 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 15 Apr 2024 (actual)
First posted: 14 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: Whole-body electrical stimulationThis 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.
Control	No intervention	–This group will not receive any type of electrical stimulation or exercise.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Elderly people aged between 60 and 85 years;
Both sexes;
To have the ability to walk.

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whole-body electrical stimulationAlso: Whole-body electromyostimulationThe 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	Intervention

Primary outcome

Functional mobility.
Time frame: Baseline, after 4 and 8 weeks.
Functional mobility will be assessed using the "Timed Up and Go" test.
Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D).
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.

17 secondary outcomes

Isometric muscle strength of the quadriceps muscle.
Time frame: Baseline and after 8 weeks.
Isometric muscle strength of the biceps brachii.
Time frame: Baseline and after 8 weeks.
Isometric handgrip strength.
Time frame: Baseline and after 8 weeks.
Lower limb muscle strength.
Time frame: Baseline, after 4 and 8 weeks.
Body composition.
Time frame: Baseline and after 8 weeks.
Cellular senescence.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Time frame: Baseline, after 4 and 8 weeks.
Inflammatory profile.
Time frame: Baseline, after 4 and 8 weeks.
Well-being.
Time frame: Baseline, after 4 and 8 weeks.
Muscle damage.
Time frame: Baseline, after 4 and 8 weeks.
Muscle pain measured by analogic visual scale (AVS).
Time frame: Baseline and after 8 weeks.
Sleep quality.
Time frame: Baseline and after 8 weeks.
Change in heart rate.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in peripheral oxygen saturation.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in systolic blood pressure.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.
Change in diastolic blood pressure.
Time frame: Baseline and after 20 minutes of whole-body electrical stimulation.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Whole-body electrical stimulation in people with Aged, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional mobility. (time frame: Baseline, after 4 and 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.