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Completed

NCT Number: NCT06669598

ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in 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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi del Molise

Campobasso, CB, 86100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Body Electromyostimulation

Other

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

Control Group

Behavioral

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.

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

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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