Effects of Microcurrent Treatment With and Without Resistance Exercises

NCT05567237 | Recruiting

• 1 other identifier: HUS0120
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.
• 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.

Conditions

Sarcopenia; Ageing Well

Keywords

microcurrent; resistance exercises; adults; MENS

Outcome Measures

Primary Outcomes (2)

• 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.

  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

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

Secondary Outcomes (1)

• Changes Neutrophils to Lymphocyte ratio (NLR)

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

Study Arms (4)

Microcurrent alone (MC)

ACTIVE COMPARATOR

This group will receive a live microcurrent device and they will not be engaged in any resistance training exercises.

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)

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.

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)

Other: Resistance exercise programme

Interventions

Microcurrent treatment with resistance exercise programme OTHER

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

Microcurrent with exercise (MC + RT)

Resistance exercise programme OTHER

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

Sham with exercise (SH + RT)

Microcurrent treatment OTHER

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

Microcurrent alone (MC)

No treatment OTHER

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

Sham alone (SH)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Greenwich: lead

Study Sites (1)

School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm

London, SE9 2BT, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 33295832 BACKGROUND

• 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.

  PMID: 31624949 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Fernando Naclerio, PhD

  University of Greenwich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Naclerio, PhD

CONTACT

020 8331 8441; f.j.naclerio@greenwich.ac.uk

Stefan Kolimechkov, PhD

CONTACT

07999578700; dr.stefan.kolimechkov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomised, balanced, double-blind parallel-group between-participants design. The participants will not know whether they receive sham or live microcurrent. Both devices (microcurrent and sham) will look exactly the same in terms of appearance, colour, size and weight. The current transmitted from the microcurrent device is insufficient to stimulate sensory nerve fibres, so participants will not be able to feel it, and due to the fact that the devices will have the same appearance, neither participants nor researchers will be able to identify those participants allocated to the MC or the SH groups. Only one researcher who will not be involved in the assessments and training supervision will know the participant allocation during the intervention (unblinded researcher).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: October 5, 2022
• Study Start: May 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: August 31, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)