NMES Effects on Substrate Metabolism and IGF-1
Metabolic Health, IGF-1, and Cardiovascular Fitness Responses to High-intensity Interval Training and Moderate-intensity Continuous Training in Combination with Superimposed Neuromuscular Electrical Stimulation
2 other identifiers
interventional
24
1 country
1
Brief Summary
The aim of this study is to investigate whether neuromuscular electrostimulation (NMES) training coupled with high-intensity interval training (HIIT) and moderate intensity continuous aerobic training has an effect on the metabolic, cardiovascular and hormonal components compared to respective training protocols without concurrent NMES as a exercise performance enhancement strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedFebruary 27, 2025
February 1, 2025
1.9 years
February 20, 2025
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (10)
Body composition via Bioelectrical Impedance Analysis (Tanita 418-MA, Japan)
Weight (kg) Total body fat (kg) Total muscle mass (kg) The anthropometric parameters were assessed using Bioelectrical impedance analysis (Tanita 418- MA Japan) before all testing sessions.
From enrollment to the end of treatment at 8 weeks
Height (cm) via a stadiometer (Holtain Ltd., UK).
Height was measured through a stadiometer in the standing position (Holtain Ltd., Crymych, UK).
From enrollment to the end of treatment at 8 weeks
Heart rate (bpm) via 12-lead ECG
Heart rate was monitored and recorded throughout baseline and follow-up screenings and all training sessions using 12-lead ECG.
From enrollment to the end of treatment at 8 weeks
Blood Lactate Concentration (mmol/L) via Lactate Pro 2 analyzer
In each GXT testing session (pre-post), blood samples were collected from the earlobe using a Lactate Pro 2 handheld analyzer (LT-1730, Arkray Inc, Kyoto, Japan) to determine blood lactate concentrations testing session (baseline) and at the end of every two minutes interval.
From enrollment to the end of treatment at 8 weeks
SERUM INSULIN-LIKE GROWTH FACTOR-1 (IGF-1 ng/mL)
A 5 mL fasting blood sample was drawn from the brachial vein 30 minutes before baseline and follow-up IVO2max tests to measure serum IGF-1 concentrations. Participants rested for 15 minutes before sample collection. Samples were stored at -80 °C and analyzed post-study. Serum IGF-1 levels were measured using Elabscience ELISA kits (detection range: 1.56-100 ng/mL; sensitivity: 0.94 ng/mL) per the manufacturer's instructions.
From enrollment to the end of treatment at 8 weeks
VO2 - Volume of oxygen (ml/kg/min) VCO2 - Volume of carbon dioxide (ml/kg/min)
During all sessions, VO2 and VCO2 were measured using indirect calorimetry (CareFusion MasterScreen CPX) on an Ergoline Ergoselect 100/200 cycle ergometer. Data was averaged over 15-second intervals during all baseline and follow-up screenings and all training sessions. VO2 and VCO2 were also used to calculate respiratory exchange ratio (RER) during all sessions dividing the VCO2 by VO2.
From enrollment to the end of treatment at 8 weeks
Energy expenditure (L/min) via indirect calorimetry (CareFusion MasterScreen CPX).
During all sessions, energy expenditure was measured using indirect calorimetry (CareFusion MasterScreen CPX). Data was averaged over 15-second intervals, and substrate utilization was calculated using standard formulas. * (GOR)- Oxidation rate of sugar (g/min): 4.585 × VCO2 (L/min) -3.2256 × VO2 (L/min) * (GO)- Oxidation amount of sugar (g): Oxidation rate of sugar × Time (min) * (FOR)- Fat oxidation rate (g/min): 1.695 × VO2 (L/min) -1.701 × VCO2 (L/min) ④ (FO)- Oxidation amount of fat (g): Oxidation rate of fat × Time (min) * (EER)- Energy consumption rate (kcal/min): 3.716 × VO2 (L/min) +1.332 × VCO2 (L/min) ⑥ (EE)- Energy expenditure (kcal): \[3.716 × VO2 (L/min) +1.332 × VCO2 (L/min)\] × Time (min)
From enrollment to the end of treatment at 8 weeks
Neuromuscular Electrical Stimulation (NMES) Protocol
The NMES protocol was administered via a four-channel COMPEX SP4.0 (Medicompex SA, Ecublens, Switzerland) electric muscle stimulator using biphasic symmetric rectangular pulsed currents set at 300 μs. COMPEX self-adhesive electrodes were used during muscle stimulation with the COMPEX device. Positive snap electrodes (5×5 cm) with a membrane depolarization that stimulate a 25 cm2 area of the muscle surface were placed on the proximal insertion of vastus medialis and vastus lateralis. The other negative electrode (10×5 cm), measuring 50 cm2 was placed over the femoral triangle, 1-3 cm below the inguinal ligament.
From enrollment to the end of treatment at 8 weeks
Low-frequency Neuromuscular Electrical Stimulation (NMES)
The low-frequency NMES protocol was administered via a four-channel COMPEX SP4.0 (Medicompex SA, Ecublens, Switzerland) electric muscle stimulator using biphasic symmetric rectangular pulsed currents set at 200 μs. Low-frequency NMES protocol was performed with a duty cycle of 20 seconds on (stimulating) and 20 seconds off (no stimulation) and the pulse width was set at 300 μs (warm-up frequency: 3 Hz, training frequency: 20 Hz, wave: square waveform) to the quadriceps muscle throughout 24 sessions. The duration of training was 30 minutes for sessions 1-6, 36 minutes for sessions 7-12, 42 minutes for sessions 13-18, and 48 minutes for sessions 19-24.
From enrollment to the end of treatment at 8 weeks
High-frequency Neuromuscular Electrical Stimulation (NMES)
High-frequency NMES protocol was administered via a four-channel COMPEX SP4.0 (Medicompex SA, Ecublens, Switzerland) electric muscle stimulator using biphasic symmetric rectangular pulsed currents set at 300 μs. High-freqeuncy NMES protocol consisted of a 5-minute warm-up (65% VO2max) followed by a 1-minute exercise at 120% VO2max and then a 1-minute "loadless" cycling. This interval was repeated 8 times in sessions 1-6 and progressed to 14 repeated intervals by the 24th session. Participants also received an additional NMES treatment with a duty cycle of 12 seconds on (stimulating) and 8 seconds off (no stimulation) and a pulse width of 300 μs (training frequency: 45-60 Hz, wave: square waveform) to the quadriceps muscle throughout 24 sessions.
From enrollment to the end of treatment at 8 weeks
Study Arms (3)
Assessment of baseline anthropometric, demographic and physiological components
EXPERIMENTALCompletion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols
EXPERIMENTALAssessment of post-test anthropometric, demographic and physiological components
EXPERIMENTALInterventions
The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.
Eligibility Criteria
You may qualify if:
- \- All participants were healthy with no musculoskeletal injuries and had not participated in lower-body resistance training for six months prior to the study.
You may not qualify if:
- Individuals with musculoskeletal injuries and had participated in lower-body resistance training for six months prior to the study has been excluded from the enrollement for the current study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mersin University
Yenişehir, Mersin, 33343, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nevzat Demirci, PhD
Mersin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASSISTANT PROFESSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
February 27, 2025
Study Start
March 17, 2017
Primary Completion
February 13, 2019
Study Completion
February 13, 2019
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.