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

NCT06669598 | Completed

• 1 other identifier: 11487/2020
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Experimental Training Group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

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

Experimental Training Group

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.

Control group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Molise: lead

Study Sites (1)

Università degli Studi del Molise

Campobasso, CB, 86100, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. Prof.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: January 7, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)