跳至主要内容
临床试验/NCT05567237
NCT05567237招募中不适用

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

University of Greenwich1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Change of body fat

研究概览

简要总结

  • 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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).

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Microcurrent alone (MC)

Active Comparator

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

干预措施: Microcurrent treatment (Other)

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)

干预措施: Microcurrent treatment with resistance exercise programme (Other)

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)

干预措施: Resistance exercise programme (Other)

Sham alone (SH)

Sham Comparator

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

干预措施: No treatment (Other)

结局指标

主要结局

Change of body fat

时间窗: 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

时间窗: 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

次要结局

  • Changes Neutrophils to Lymphocyte ratio (NLR)(The white blood cells count will be measured to track changes at week 6.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Naclerio

Professor

University of Greenwich

研究点 (1)

Loading locations...

相似试验