Mild Cognitive ImpairmentNCT06669598
ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in INDIVIDUALS AT RISK of DEMENTIA USING WHOLE-BODY ELECTROMYOSTIMULATION
A study testing Whole Body Electromyostimulation in people with Mild Cognitive Impairment, run by University of Molise at 1 site in Italy.
Trial summary
This study aimed to evaluate the effectiveness of twelve weeks whole-body electrical muscle stimulation combined with aerobic exercises. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Whole Body Electromyostimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 55 to 85 years;
- no simultaneous participation in any type of supervised physical activity;
- Sedentary lifestyle
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Whole Body Electromyostimulation, control group
- Keywords
- WB-Electromyostimulation; EMS; electrical muscle stimulation; muscle strength; neurodegenerative disease; cardiovascular training
- Medical subject headings
- Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body ElectromyostimulationOther
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-second arm curl test
Measured: At the end of 12 weeks
30-second sit-to-stand test
Measured: At the end of 12 weeks
hand grip strength test
Measured: At the end of 12 weeks
6-minute walking test
Measured: At the end of 12 weeks
8-foot up and go test
Measured: At the end of 12 weeks
Chair Sit and Reach Test
Measured: At the end of 12 weeks
Soda Pop Test
Measured: At the end of 12 weeks
Tinetti Balance and Gait Test
Measured: At the end of 12 weeks
Mini-Mental State Examination (MMSE)
Measured: At the end of 12 weeks
Rey's Auditory Verbal Learning Test (RAVLT)
Measured: At the end of 12 weeks
Stroop Colour and Word Interference Test (SCWT)
Measured: At the end of 12 weeks
Trail Making Test (TMT)
Measured: At the end of 12 weeks
Attentional Matrices Test
Measured: At the end of 12 weeks
Prose recall test ( babcock)
Measured: At the end of 12 weeks
Frontal Assessment battery (FAB)
Measured: At the end of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start7 Jan 2024
- Primary completion15 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Calcagno, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669598
- Sponsor's protocol ID
- 11487/2020
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in ELDERLY INDIVIDUALS AT RISK of DEMENTIA USING WHOLE-BODY ELECTROMYOSTIMULATION
- ClinicalTrials.gov ID
- NCT06669598
- Acronym / sponsor ID
- 11487/2020
- Conditions
- Mild Cognitive Impairment
- Keywords
- WB-Electromyostimulation; EMS; electrical muscle stimulation; muscle strength; neurodegenerative disease; cardiovascular training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the effectiveness of twelve weeks whole-body electrical muscle stimulation combined with aerobic exercises.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Training Group | Experimental | Other: Whole Body ElectromyostimulationThe 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. |
| Control group | Active comparator | Behavioral: control groupThe 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 55 to 85 years;
- no simultaneous participation in any type of supervised physical activity;
- Sedentary lifestyle
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body ElectromyostimulationThe 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 | Other | Experimental Training Group |
| control groupThe 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. | Behavioural | Control group |
Primary outcome
30-second arm curl test
Time frame: At the end of 12 weeks
30-second sit-to-stand test
Time frame: At the end of 12 weeks
hand grip strength test
Time frame: At the end of 12 weeks
6-minute walking test
Time frame: At the end of 12 weeks
8-foot up and go test
Time frame: At the end of 12 weeks
Chair Sit and Reach Test
Time frame: At the end of 12 weeks
Soda Pop Test
Time frame: At the end of 12 weeks
Tinetti Balance and Gait Test
Time frame: At the end of 12 weeks
Mini-Mental State Examination (MMSE)
Time frame: At the end of 12 weeks
Rey's Auditory Verbal Learning Test (RAVLT)
Time frame: At the end of 12 weeks
Stroop Colour and Word Interference Test (SCWT)
Time frame: At the end of 12 weeks
Trail Making Test (TMT)
Time frame: At the end of 12 weeks
Attentional Matrices Test
Time frame: At the end of 12 weeks
Prose recall test ( babcock)
Time frame: At the end of 12 weeks
Frontal Assessment battery (FAB)
Time frame: At the end of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Electromyostimulation in people with Mild Cognitive Impairment, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-second arm curl test (time frame: At the end of 12 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.