NCT06850532

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

February 20, 2025

Last Update Submit

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

EXPERIMENTAL
Other: IGF-1

Completion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols

EXPERIMENTAL
Other: IGF-1

Assessment of post-test anthropometric, demographic and physiological components

EXPERIMENTAL
Other: IGF-1

Interventions

IGF-1OTHER

The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.

Assessment of baseline anthropometric, demographic and physiological componentsAssessment of post-test anthropometric, demographic and physiological componentsCompletion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Interventions

Insulin-Like Growth Factor I

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Officials

  • Nevzat Demirci, PhD

    Mersin University

    STUDY DIRECTOR

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

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations