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SarcopeniaNCT05567237

Effects of Microcurrent Treatment With and Without Resistance Exercises

A study testing Microcurrent treatment with resistance exercise programme, Resistance exercise programme and Microcurrent treatment in people with Sarcopenia and Ageing Well, run by University of Greenwich at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim: to analyse the effects of microcurrent treatment alone, and combined with a resistance exercise programme, on muscle strength, body composition and physical functional capacity in middle-aged adults. Methods Randomised, balanced, double-blind parallel-group between-participants design. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Ageing Well
What is being tested?
Microcurrent treatment with resistance exercise programme, Resistance exercise programme and Microcurrent treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2022to 31 Aug 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 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • non-regularly trained male and female adults, aged 40 to 65 years old.

Who cannot join

  • with no musculoskeletal injuries, metabolic conditions, or diseases or currently taking medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery processes (e.g., creatine, whey protein, and amino acids, vitamin, or mineral supplementation, etc.) within 6 weeks prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm

    London, SE9 2BT

    Fernando Naclerio, PhD, 2083318441 ext. +44, f.j.naclerio@gre.ac.uk

    Stefan Kolimechkov, PhD, 07999578700 ext. +44, dr.stefan.kolimechkov@gmail.com

    Recruiting

Other trials in United Kingdom

About this study

Official title: Effects of Microcurrent Treatment With and Without Resistance Exercises on Body Composition, Muscle Strength, and Physical Function in Middle-aged Adults

  • Aim: to analyse the effects of microcurrent treatment alone, and combined with a resistance exercise programme, on muscle strength, body composition and physical functional capacity in middle-aged adults.
  • Methods
  • Randomised, balanced, double-blind parallel-group between-participants design.
  • Participants - non-regularly trained adults (people who do not engage regularly in physical sessions), aged 40 to 65 years old.
  • All participants will be invited to take part in a 6-week supervised resistance training programme that will be combined with microcurrent (MC) or sham (SH) intervention. The participants who do not accept to undergo the resistance training programme will integrate a non-exercise group involving a 6-week intervention period using the microcurrent (MC) or the sham (SH) device. The devices will be provided by Arc4Health (ARC Microtech Ltd, UK; https://arcmicrotech.com/arc4health/). The device Arc4Health has regulatory approval as a Class IIa medical device in the areas of pain management and tissue repair.

The following will be analysed:

Read more
  1. Microcurrent alone (MC)
  2. Microcurrent with exercise (MC + RT)
  3. Sham alone (SH)
  4. Sham with exercise (SH + RT)
  • The participants who agree to take part in the training programme will have 2 sessions a week for a period of 6 weeks. The training programme involves elastic bands and is designed to increase strength and muscle mass.
  • Measurements of body composition (via plethysmography BodPod), strength, functional capacity, muscular structure (via non-invasive ultrasound), and immunological blood markers will be undertaken at baseline and after the 6-week intervention period.
Read the detailed description

Microcurrent therapy is non-invasive method that provides different frequencies and transmits tiny currents through the skin within the range of milliamperes (<1 mA). Human studies demonstrated that microcurrent can reduce the severity of symptoms of muscle damage induced by exercise protocols in healthy men, healthy men and women, trained men, and cross-country male athletes. To the best of the authors' knowledge, no formal research has been conducted to verify the effects of microcurrent added to resistance exercises on physical function in non-trained middle-aged adults. Therefore, it is important to understand to what extent the application of microcurrent added to physical exercises (the hallmark of prevention and treatment of sarcopenia) can slow the age-related decline of muscular function and play a role in the prevention of sarcopenia.

Aim: To analyse the effects of microcurrent treatment alone, and combined with a resistance exercise programme, on muscle strength, body composition and physical function in middle-aged adults.

Hypotheses (i) Microcurrent alone will counteract the loss of muscle mass and strength which accompanies ageing, and it will improve functional capacity and wellbeing compared to a sham, non-microcurrent treatment, in individuals with a low level of physical activity (sedentary population who are not engaged in regular exercise programmes).

(ii) The application of microcurrent alone, although not improving strength, will counteract the loss of muscle mass and strength in sedentary individuals.

(iii) Adding a resistance training programme to microcurrent treatment will optimise exercise-induced outcomes, allowing superior gains in muscle mass, strength, functional capacity, and wellbeing, compared to the application of microcurrent alone.

Experimental design

The study involves a 6-week randomised, balanced, double-blind parallel group between-participants design, which will analyse the effects of microcurrent on health-related parameters. Once considered eligible, the participants will be randomly assigned to the following two groups:

  1. Microcurrent (MC)
  2. Sham (SH) All participants will be offered to take part in a supervised resistance training (RT) programme which will be combined with either the MC or SH intervention.

The participants who do not accept to undergo the resistance training programme will integrate a non-exercise group involving a 6-week intervention period using the microcurrent (MC) or the sham (SH) device. Those participants who accept to perform the resistance training programme (regardless of being previously allocated to MC + RT or SH + RT) will perform a 2-session familiarization before the beginning of the study. Then, they will follow the exercise programme of 2 training sessions per week for 6 weeks (12 sessions in all).

Participants will wear the microcurrent or sham device on the dominant upper arm for a period of 3 hours every day. For those included in the exercise group, the device will be used immediately after each training session, and in the mornings on the non-training days. For those included in the non-exercise group, the device will be worn in the mornings. Measurements of body composition, muscle thickness, functional capacity, and blood indices of health and wellbeing will be determined before (T1) and after the 6-week intervention period (T2).

In summary, the following four treatment conditions are expected to be analysed:

(i) Microcurrent alone (MC) (ii) Microcurrent with exercise (MC + RT) (iii) Sham alone (SH) (iv) Sham with exercise (SH + RT)

Intervention Familiarization period The participants from the MC+RT and SH+RT groups will undertake 2 sessions (on 2 non-consecutive days in 1 week) of familiarization, supervised by a qualified strength and conditioning instructor (graduate or MSc student). The familiarization aims to instruct the participants on how to perform the selected exercises, control breathing and control intensity. The Rate of Perceived Exertion OMNI-RES scale will be used to control the level of resistance and monitor participants' progression. The proposed OMNI-RES scale with elastic bands was previously validated for prescribing exercise intensity with TheraBand resistance bands in older adults.

During the familiarization, participants will be asked to execute 1 set of 10 reps with different resistance bands (and with different grip widths) to establish the initial level of resistance, which will be thereafter scheduled for the intervention. The elastic bands will be marked with numerical points 3 cm apart throughout the band to objectify the grip width. A few attempts of each exercise will be allowed in order to find, and objectively feel the correct resistance. Once the resistance level is achieved, the colour and the corresponding bandwidth will be recorded for each participant in each particular exercise.

Resistance Training Programme (RT) The RT programme will be performed over a 6-week (12 sessions in total) training intervention using elastic bands.

The RT programme involves 8 multi-joint and single-joint exercises targeting the whole-body musculature. The exercises will be performed in the following order: 1. Squat with shoulder press, 2. Biceps curl, 3. Squat, 4. Lat-pull down, 5. Deadlift, 6. Triceps extension, 7. Lunge, and 8. Upright row. The participants will perform 3 sets of 12 to 15 repetitions with ~1.5 to 2 min rest between sets of each exercise. The estimated duration of each workout is 60 min including a standardised 10-min warm-up with dynamic and static flexibility exercises (10 min).

The participants will be surveyed to find out whether middle-aged and older people prefer to perform the exercise programme (RT) in a group supervised face-to-face setting at our Avery Hill Campus, or in their home following a pre-recorded video session or live session. The current COVID restrictions on physical activities which take place in venues will also be considered. It will be anticipated that all sessions are conducted under the supervision (live or online) of at least one qualified instructor on non-consecutive days (48 hours apart). To avoid dropout of participants, giving them the opportunity to train at their convenient time by watching a pre-recorded RT online session (and submitting a short google form immediately after completing the workout online) will also be considered.

Training load

As indicated earlier, the participants will execute 3 sets of a minimum of 12 to a maximum of 15 repetitions of each exercise with ~1.5 to 2 min rest between sets (consisting of stretching elements without the use of the bands). The following progression model protocol will be implemented:

  • First block (week 1) - participants should reach a rate of perceived exertion (RPE) of 6 to a maximum of 7 at the end of each set of 12 reps. When an RPE lower than 6 is reported at the end of the set, the participant will be asked to increase the number of repetitions to a maximum of 15 in the subsequent sets, always maintaining a final RPE no higher than 7.
  • Second block (week 2) - participants should reach an RPE of 7 to a maximum of 8 at the end of each set of 12 reps. When an RPE lower than 7 is reported at the end of the set, the participant will be asked to increase the number of repetitions to a maximum of 15 in the subsequent sets, always maintaining a final RPE no higher than 8.
  • Third block (week 3 to week 6) - participants should reach an RPE of 8 to a maximum of 9 at the end of each set of 12 reps. When an RPE lower than 8 is reported at the end of the set, the participant will be asked to increase the number of repetitions to a maximum of 15 in the subsequent sets, always maintaining a final RPE no higher than 9. For those participants who still feel that the effort is easier than the expected rate, the magnitude of the resistance can be increased by shortening the grip width of the band or changing to a different band colour/level offering a higher resistance.

Intervention protocol (microcurrent or sham device) The Arc4Health microcurrent device (approved as a Class IIa medical device in the areas of pain management and tissue repair) will be used in the study.

Participants will wear the microcurrent or sham device on the dominant upper arm for 3 hours every day (after each session on a training day and in the morning on all other days) or in every morning for those who are not taking part in the resistance training. It is expected that participants will be exposed to 21 hours of microcurrent (Programme 1) or sham stimulus per week (a total of 126 hrs for 6 weeks).

Expected outcomes from the investigation It is expected that results from the current project will demonstrate the potential benefits of microcurrent treatment alone and combine microcurrent with resistance training to maximise the benefits on body composition, muscle strength, and muscle function in middle-aged adults.

Being tested
Microcurrent treatment with resistance exercise programme, Resistance exercise programme, Microcurrent treatment, No treatment
Keywords
microcurrent, resistance exercises, adults, MENS
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microcurrent treatment with resistance exercise programmeOther

    This intervention will allow us to explore the effects of microcurrent added to resistance exercise.

  • Resistance exercise programmeOther

    This intervention works as a control group for the participants undergoing the exercise programme.

  • Microcurrent treatmentOther

    This intervention will allow us to explore the effects of microcurrent alone.

  • No treatmentOther

    This intervention works as a control group for the participants who are not taking part into the exercise programme.

Study groups in NCT05567237
Study groupRoleWhat they receive
Microcurrent alone (MC)Active comparatorThis group will receive a live microcurrent device and they will not be engaged in any resistance training exercises.
Receives: Other: Microcurrent treatment
Microcurrent with exercise (MC + RT)Active comparatorThis group will receive a live microcurrent device and they will follow an exercise programme of 2 training sessions per week for 6 weeks (12 sessions in all)
Receives: Other: Microcurrent treatment with resistance exercise programme
Sham alone (SH)Sham comparatorThis group will receive a sham microcurrent device and they will not be engaged in any resistance training exercises.
Receives: Other: No treatment
Sham with exercise (SH + RT)Sham comparatorThis group will receive a sham microcurrent device and they will follow an exercise programme of 2 training sessions per week for 6 weeks (12 sessions in all)
Receives: Other: Resistance exercise programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of body fat

    Air displacement plethysmography (BodPod) will be used to calculate the percentage of body fat of the participants. Measurements will be collected in kg and then the percentage relative to body mass will be calculated.

    Measured: The body fat will be assessed to measure changes at week 6.

  2. Change of muscle thickness

    Using Ultrasound (Affiniti 50 Ultrasound system) to measure thickness of Elbow flexors (Brachialis and Biceps) and Vastus Lateralis. Measurements will be collected in millimeters

    Measured: The muscle thickness will be measured to track changes at week 6.

Secondary outcomes (1)
  1. Changes Neutrophils to Lymphocyte ratio (NLR)

    White blood cells will be measured by using the HemoCue® WBC DIFF System. Values of Neutrophils to Lymphocytes will be collected in 10(9)/L

    Measured: The white blood cells count will be measured to track changes at week 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start1 May 2022
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double-blind parallel-group between-participants design, which will analyse the effects of microcurrent on health-related parameters. Once considered eligible, the participants will be randomly assigned to the following two groups: 1. Microcurrent (MC) 2. Sham (SH) Thereafter, all of the participants will be offered to take part in a supervised resistance training (RT) programme which will be combined with either the MC or SH intervention. The participants who do not accept to undergo the resistance training programme will integrate a non-exercise group involving a 6-week intervention period using the microcurrent (MC) or the sham (SH) device. Those participants who accept to perform the resistance training programme (regardless of being previously allocated to MC + RT or SH + RT) will perform a 2-session familiarization before the beginning of the study. Then, they will follow the exercise programme of 2 training sessions per week for 6 weeks (12 sessions in all).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567237
Sponsor's protocol ID
HUS0120
Status last verified
Jul 2024
First submitted
12 Sep 2022
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not yet known if there will be a plan to make IPD available

Publications

  • Naclerio F, Moreno-Perez D, Seijo M, Karsten B, Larrosa M, Garcia-Merino JAL, Thirkell J, Larumbe-Zabala E. Effects of adding post-workout microcurrent in males cross country athletes. Eur J Sport Sci. 2021 Dec;21(12):1708-1717. doi: 10.1080/17461391.2020.1862305. Epub 2021 Feb 8.

    PubMed 33295832
  • Naclerio F, Seijo M, Karsten B, Brooker G, Carbone L, Thirkell J, Larumbe-Zabala E. Effectiveness of combining microcurrent with resistance training in trained males. Eur J Appl Physiol. 2019 Dec;119(11-12):2641-2653. doi: 10.1007/s00421-019-04243-1. Epub 2019 Oct 17.

    PubMed 31624949

Questions about this trial

What is this clinical trial studying?

A study testing Microcurrent treatment with resistance exercise programme, Resistance exercise programme and Microcurrent treatment in people with Sarcopenia and Ageing Well, run by University of Greenwich at 1 site in United Kingdom.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fernando Naclerio, PhD (020 8331 8441 ext. +44, f.j.naclerio@greenwich.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of body fat (time frame: The body fat will be assessed to measure changes at week 6.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567237, which also lists 2 linked publications.

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 24 Jul 2024.

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