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.
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
- 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
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
- Microcurrent alone (MC)
- Microcurrent with exercise (MC + RT)
- Sham alone (SH)
- 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:
- Microcurrent (MC)
- 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.
- Conditions
- Sarcopenia, Ageing Well
- 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 group | Role | What they receive |
|---|---|---|
| Microcurrent alone (MC) | Active comparator | This 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 comparator | This 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 comparator | This 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 comparator | This 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.
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.
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)
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.
- First posted5 Oct 2022
- Study start1 May 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Fernando Naclerio, PhD, Principal investigator, University of Greenwich
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 33295832Naclerio 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microcurrent Treatment With and Without Resistance Exercises on Body Composition, Muscle Strength, and Physical Function in Middle-aged Adults
- ClinicalTrials.gov ID
- NCT05567237
- Acronym / sponsor ID
- HUS0120
- Conditions
- Sarcopenia, Ageing Well
- Keywords
- microcurrent, resistance exercises, adults, MENS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 5 Oct 2022 (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.
- 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:
- Microcurrent alone (MC)
- Microcurrent with exercise (MC + RT)
- Sham alone (SH)
- 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.
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:
- Microcurrent (MC)
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Microcurrent alone (MC) | Active comparator | Other: Microcurrent treatmentThis group will receive a live microcurrent device and they will not be engaged in any resistance training exercises. |
| Microcurrent with exercise (MC + RT) | Active comparator | Other: Microcurrent treatment with resistance exercise programmeThis 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) |
| Sham alone (SH) | Sham comparator | Other: No treatmentThis group will receive a sham microcurrent device and they will not be engaged in any resistance training exercises. |
| Sham with exercise (SH + RT) | Sham comparator | Other: Resistance exercise programmeThis 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) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-regularly trained male and female adults, aged 40 to 65 years old.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Microcurrent treatment with resistance exercise programmeThis intervention will allow us to explore the effects of microcurrent added to resistance exercise. | Other | Microcurrent with exercise (MC + RT) |
| Resistance exercise programmeThis intervention works as a control group for the participants undergoing the exercise programme. | Other | Sham with exercise (SH + RT) |
| Microcurrent treatmentThis intervention will allow us to explore the effects of microcurrent alone. | Other | Microcurrent alone (MC) |
| No treatmentThis intervention works as a control group for the participants who are not taking part into the exercise programme. | Other | Sham alone (SH) |
Primary outcome
Change of body fat
Time frame: The body fat will be assessed to measure changes at week 6.
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.
Change of muscle thickness
Time frame: The muscle thickness will be measured to track changes at week 6.
Using Ultrasound (Affiniti 50 Ultrasound system) to measure thickness of Elbow flexors (Brachialis and Biceps) and Vastus Lateralis. Measurements will be collected in millimeters
1 secondary outcome
Changes Neutrophils to Lymphocyte ratio (NLR)
Time frame: The white blood cells count will be measured to track changes at week 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 33295832Naclerio 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.
- Background: PubMed 31624949Naclerio 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.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Fernando Naclerio, PhD principal investigator
University of Greenwich
1 site in 1 country: see every site and its status.
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.