ClinicalTrials.gg
CompletedNCT06669598Updated Nov 1, 2024

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

An interventional study of Whole Body Electromyostimulation and control group in Mild Cognitive Impairment, sponsored by University of Molise. Completed at 1 site in Italy. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-01.

Sponsored by University of Molise · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2024, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • WB-Electromyostimulation; EMS; electrical muscle stimulation; muscle strength; neurodegenerative disease; cardiovascular training
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's enrollment of 61 is close to the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Molise is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherWhole 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

  • Behavioralcontrol 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.

06

What researchers measure

Primary outcomes

  1. 30-second arm curl test

    Time frame: At the end of 12 weeks

  2. 30-second sit-to-stand test

    Time frame: At the end of 12 weeks

  3. hand grip strength test

    Time frame: At the end of 12 weeks

  4. 6-minute walking test

    Time frame: At the end of 12 weeks

  5. 8-foot up and go test

    Time frame: At the end of 12 weeks

  6. Chair Sit and Reach Test

    Time frame: At the end of 12 weeks

  7. Soda Pop Test

    Time frame: At the end of 12 weeks

  8. Tinetti Balance and Gait Test

    Time frame: At the end of 12 weeks

  9. Mini-Mental State Examination (MMSE)

    Time frame: At the end of 12 weeks

  10. Rey's Auditory Verbal Learning Test (RAVLT)

    Time frame: At the end of 12 weeks

  11. Stroop Colour and Word Interference Test (SCWT)

    Time frame: At the end of 12 weeks

  12. Trail Making Test (TMT)

    Time frame: At the end of 12 weeks

  13. Attentional Matrices Test

    Time frame: At the end of 12 weeks

  14. Prose recall test ( babcock)

    Time frame: At the end of 12 weeks

  15. Frontal Assessment battery (FAB)

    Time frame: At the end of 12 weeks

07

Study locations

1 site
  • Università degli Studi del Molise
    Campobasso, CB 86100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06669598
Lead sponsor
University of Molise
Responsible party
Giuseppe Calcagno (Dott. Prof., University of Molise) — Principal investigator
First posted
Nov 1, 2024
Start date
Jan 7, 2024
Primary completion
May 15, 2024
Completion
Jun 30, 2024
Last update
Nov 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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