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

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: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Whole Body Electromyostimulation; Behavioral: control group

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: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
30-second arm curl test	At the end of 12 weeks
30-second sit-to-stand test	At the end of 12 weeks
hand grip strength test	At the end of 12 weeks
6-minute walking test	At the end of 12 weeks
8-foot up and go test	At the end of 12 weeks
Chair Sit and Reach Test	At the end of 12 weeks
Soda Pop Test	At the end of 12 weeks
Tinetti Balance and Gait Test	At the end of 12 weeks
Mini-Mental State Examination (MMSE)	At the end of 12 weeks
Rey's Auditory Verbal Learning Test (RAVLT)	At the end of 12 weeks
Stroop Colour and Word Interference Test (SCWT)	At the end of 12 weeks
Trail Making Test (TMT)	At the end of 12 weeks
Attentional Matrices Test	At the end of 12 weeks
Prose recall test ( babcock)	At the end of 12 weeks
Frontal Assessment battery (FAB)	At the end of 12 weeks

Collaborators and Investigators

• Sponsor: University of Molise

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2024
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: WB-Electromyostimulation; EMS; electrical muscle stimulation; muscle strength; neurodegenerative disease; cardiovascular training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID 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