Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-01-02 @ 11:12 AM
Study NCT ID:
NCT06850532
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NMES Effects on Substrate Metabolism and IGF-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007334', 'term': 'Insulin-Like Growth Factor I'}], 'ancestors': [{'id': 'D013002', 'term': 'Somatomedins'}, {'id': 'D000096764', 'term': 'Insulin-Like Peptides'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition via Bioelectrical Impedance Analysis (Tanita 418-MA, Japan)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'Height (cm) via a stadiometer (Holtain Ltd., UK).', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Height was measured through a stadiometer in the standing position (Holtain Ltd., Crymych, UK).'}, {'measure': 'Heart rate (bpm) via 12-lead ECG', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Heart rate was monitored and recorded throughout baseline and follow-up screenings and all training sessions using 12-lead ECG.'}, {'measure': 'Blood Lactate Concentration (mmol/L) via Lactate Pro 2 analyzer', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'SERUM INSULIN-LIKE GROWTH FACTOR-1 (IGF-1 ng/mL)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': "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."}, {'measure': 'VO2 - Volume of oxygen (ml/kg/min) VCO2 - Volume of carbon dioxide (ml/kg/min)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'Energy expenditure (L/min) via indirect calorimetry (CareFusion MasterScreen CPX).', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.\n\n* (GOR)- Oxidation rate of sugar (g/min): 4.585 × VCO2 (L/min) -3.2256 × VO2 (L/min)\n\n * (GO)- Oxidation amount of sugar (g): Oxidation rate of sugar × Time (min)\n\n * (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)\n\n * (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)'}, {'measure': 'Neuromuscular Electrical Stimulation (NMES) Protocol', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'Low-frequency Neuromuscular Electrical Stimulation (NMES)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'High-frequency Neuromuscular Electrical Stimulation (NMES)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Effects of Neuromuscular Electrical Stimulation on Exercise Performance']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All participants were healthy with no musculoskeletal injuries and had not participated in lower-body resistance training for six months prior to the study.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06850532', 'briefTitle': 'NMES Effects on Substrate Metabolism and IGF-1', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MEUFACULTYOFSPORTSCIENCES_2025'}, 'secondaryIdInfos': [{'id': 'BAP20172TP32576', 'type': 'OTHER_GRANT', 'domain': 'Mersin University Scientific Research Projects Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assessment of baseline anthropometric, demographic and physiological components', 'interventionNames': ['Other: IGF-1']}, {'type': 'EXPERIMENTAL', 'label': 'Completion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols', 'interventionNames': ['Other: IGF-1']}, {'type': 'EXPERIMENTAL', 'label': 'Assessment of post-test anthropometric, demographic and physiological components', 'interventionNames': ['Other: IGF-1']}], 'interventions': [{'name': 'IGF-1', 'type': 'OTHER', 'description': 'The effects of NMES coupled with HIIT and MICT on IGF-1 and substrate metabolism has not been studied earlier.', 'armGroupLabels': ['Assessment of baseline anthropometric, demographic and physiological components', 'Assessment of post-test anthropometric, demographic and physiological components', 'Completion of MICT, MICT+NMES, HIIT, and HIIT+NMES protocols']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33343', 'city': 'Yenişehir', 'state': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University', 'geoPoint': {'lat': 36.8, 'lon': 34.56667}}], 'overallOfficials': [{'name': 'Nevzat Demirci, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mersin University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'Nasuh Evrim Acar', 'investigatorAffiliation': 'Mersin University'}}}}