ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in INDIVIDUALS AT RISK of DEMENTIA USING WHOLE-BODY ELECTROMYOSTIMULATION

October 30, 2024 updated by: Giuseppe Calcagno, University of Molise

ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in ELDERLY INDIVIDUALS AT RISK of DEMENTIA USING WHOLE-BODY ELECTROMYOSTIMULATION

This study aimed to evaluate the effectiveness of twelve weeks whole-body electrical muscle stimulation combined with aerobic exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aimed to evaluate the effectiveness of twelve weeks of WB-EMS (whole-body electrical muscle stimulation at 35Hz and 350 μs) combined with aerobic exercises on a treadmill and rowing machine, in improving physical and cognitive performance in older adults, both healthy and at risk of dementia. The results were compared with those obtained from the same training without WB-EMS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CB
      • Campobasso, CB, Italy, 86100
        • Università degli studi del molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age from 55 to 85 years;
  • no simultaneous participation in any type of supervised physical activity;
  • Sedentary lifestyle

Exclusion Criteria:

  • mini-mental state examination (MMSE) score of less than 24;
  • inability to walk for 6 min without assistance;
  • the presence of a medical condition influencing the cognitive and/or motor functions;
  • the presence of any counter indication for the utilisation of EMS, such as cardiovascular diseases, stents, cardiac pacemakers, and diabetes mellitus, verified by medical certification.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Training Group
The ETG group underwent in two 20-minute training sessions per week, with 72 hours of rest between sessions. Each session included aerobic activities such as rowing and treadmill exercises, combined with supervised WB-EMS stimulation. This stimulation utilised a rectangular waveform at 35 Hz, 350 μs, with continuous pulse duration. The intensity of this training modality was set based on heart rate reserve (HRR), starting at 60% HRR in the first week and increasing by 5% every 3 weeks, reaching 80% HRR by the twelfth week.
Other: Whole Body Electromyostimulation
The ETG group underwent in two 20-minute training sessions per week (12 weeks), with 72 hours of rest between sessions. Each session included aerobic activities such as rowing and treadmill exercises, combined with supervised WB-EMS stimulation. This stimu-lation utilised a rectangular waveform at 35 Hz, 350 μs, with continuous pulse dura-tion
Active Comparator: Control group
The CON group underwent three weekly training sessions for twelve weeks, con-sisting of 20 minutes of aerobic activity, performed on a treadmill and rowing machine, without the WB-EMS superimposition.
Behavioral: control group
The CON group underwent three weekly training sessions for twelve weeks, con-sisting of 20 minutes of aerobic activity, performed on a treadmill and rowing machine, without the WB-EMS superimposition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
30-second arm curl test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
30-second sit-to-stand test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
hand grip strength test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
6-minute walking test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
8-foot up and go test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Chair Sit and Reach Test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Soda Pop Test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Tinetti Balance and Gait Test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Mini-Mental State Examination (MMSE)
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Rey's Auditory Verbal Learning Test (RAVLT)
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Stroop Colour and Word Interference Test (SCWT)
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Trail Making Test (TMT)
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Attentional Matrices Test
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Prose recall test ( babcock)
Time Frame: At the end of 12 weeks
At the end of 12 weeks
Frontal Assessment battery (FAB)
Time Frame: At the end of 12 weeks
At the end of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Molise

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11487/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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