NMES Effects on Substrate Metabolism and IGF-1

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06850532

Acronym / sponsor ID

MEUFACULTYOFSPORTSCIENCES_2025

Conditions

The Effects of Neuromuscular Electrical Stimulation on Exercise Performance

Study type

Interventional

Recruitment status

Completed

Enrolment

24 participants (actual)

Lead sponsor

Mersin UniversityUniversity, hospital or other

Study start

17 Mar 2017 (actual)

Primary completion

13 Feb 2019 (actual)

Study completion

13 Feb 2019 (actual)

First posted

27 Feb 2025 (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.

Study design

Primary purpose

Screening

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

18 to 30 years

Sex

Male only

Healthy volunteers

Accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Body composition via Bioelectrical Impedance Analysis (Tanita 418-MA, Japan)

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

2. Height (cm) via a stadiometer (Holtain Ltd., UK).

   Time frame: From enrollment to the end of treatment at 8 weeks

   Height was measured through a stadiometer in the standing position (Holtain Ltd., Crymych, UK).

3. Heart rate (bpm) via 12-lead ECG

   Time frame: From enrollment to the end of treatment at 8 weeks

   Heart rate was monitored and recorded throughout baseline and follow-up screenings and all training sessions using 12-lead ECG.

4. Blood Lactate Concentration (mmol/L) via Lactate Pro 2 analyzer

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

5. SERUM INSULIN-LIKE GROWTH FACTOR-1 (IGF-1 ng/mL)

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

6. VO2 - Volume of oxygen (ml/kg/min) VCO2 - Volume of carbon dioxide (ml/kg/min)

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

7. Energy expenditure (L/min) via indirect calorimetry (CareFusion MasterScreen CPX).

   Time frame: From enrollment to the end of treatment at 8 weeks

   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)

8. Neuromuscular Electrical Stimulation (NMES) Protocol

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

9. Low-frequency Neuromuscular Electrical Stimulation (NMES)

   Time frame: From enrollment to the end of treatment at 8 weeks

   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.

10. High-frequency Neuromuscular Electrical Stimulation (NMES)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
• Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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.

1 site in 1 country: see every site and its status.