Effects of Microcurrent Treatment With and Without Resistance Exercises
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Greenwich
About this trial
* 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:
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
non-regularly trained male and female adults, aged 40 to 65 years old.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Microcurrent treatment with resistance exercise programme
Other interventionThis intervention will allow us to explore the effects of microcurrent added to resistance exercise.
Resistance exercise programme
Other interventionThis intervention works as a control group for the participants undergoing the exercise programme.
Microcurrent treatment
Other interventionThis intervention will allow us to explore the effects of microcurrent alone.
No treatment
Other interventionThis intervention works as a control group for the participants who are not taking part into the exercise programme.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Microcurrent alone (MC)Active comparator 1 intervention
Group B: Microcurrent with exercise (MC + RT)Active comparator 1 intervention
Group C: Sham alone (SH)Sham comparator 1 intervention
Group D: Sham with exercise (SH + RT)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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
Time frame
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
Time frame
The white blood cells count will be measured to track changes at week 6.Sponsors and contacts
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Source ClinicalTrials.gov