- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06850532
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mersin
-
Yenisehir, Mersin, Turkey, 33343
- Mersin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All participants were healthy with no musculoskeletal injuries and had not participated in lower-body resistance training for six months prior to the study.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessment of baseline anthropometric, demographic and physiological components
|
The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.
|
|
Experimental: Completion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols
|
The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.
|
|
Experimental: Assessment of post-test anthropometric, demographic and physiological components
|
The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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).
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
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)
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
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.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nevzat Demirci, PhD, Mersin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MEUFACULTYOFSPORTSCIENCES_2025
- BAP20172TP32576 (Other Grant/Funding Number: Mersin University Scientific Research Projects Commission)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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