Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT07109102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Benefits of Eccentric Cycling Exercise in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is an open-label, single-centre, parallel-group, three-arm, randomised controlled study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated haemoglobin (HbA1C)', 'timeFrame': 'Baseline and post-intervention at 10 weeks'}, {'measure': 'Lipid profile', 'timeFrame': 'Baseline and post-intervention at 10 weeks'}, {'measure': 'Maximal voluntary contraction (MVC)', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks).', 'description': 'isometric quadriceps peak torque (QPT) and isokinetic QPT'}, {'measure': 'Exercise capacity', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': '6-minute walk test (6-MWT)'}, {'measure': '13-item Revised Version of Diabetes Quality of Life (RV-DQOL13)', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Scores range from 13 to 65, with higher scores reflecting reduced quality of life'}, {'measure': 'Short Form-12 (SF-12) health survey', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Scoring ranges from 0 to 100, with higher scores indicating better physical and mental health.'}], 'secondaryOutcomes': [{'measure': 'Electromyography (EMG) for muscle activity assessment', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'To assess quadriceps muscle activity (rectus femoris, vastus medialis oblique, and vastus lateralis) during maximal voluntary contraction.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and up to 10 weeks', 'description': 'systolic blood pressure (SBP), diastolic blood pressure (DBP),'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline and up to 10 weeks'}, {'measure': 'Borg Category-Ratio scale (Borg CR-10)', 'timeFrame': 'Every cycling training session from week 1 to week 10', 'description': "The scale ranges from 0 (nothing at all) to 10 (extremely strong) to represent the participants' subjective feelings of breathlessness and leg fatigue."}, {'measure': 'Body weight', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Body weight in kilograms (kg)'}, {'measure': 'Height', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Height in centimeters (cm)'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'BMI is calculated as weight (kg) divided by height (m²).'}, {'measure': 'Body circumference', 'timeFrame': 'Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Measure the waist circumference (WC), hip circumference (HC), and thigh circumference (TC) in centimetres with a measuring tape.'}, {'measure': 'The short version of the physical activity enjoyment scale (PACES-S)', 'timeFrame': 'Mid-intervention (6 weeks), and post-intervention (10 weeks)', 'description': 'Exercise enjoyment will be assessed using a five-point Likert scale (1 = strongly disagree to 5 = strongly agree), with total scores ranging from 4 to 20; higher scores indicate greater enjoyment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eccentric cycling', 'eccentric exercise', 'exercise capacity', 'quality of life', 'physiological responses', 'Type 2 diabetes mellitus'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'referencesModule': {'references': [{'pmid': '37293426', 'type': 'BACKGROUND', 'citation': 'Ansari M, Hardcastle S, Myers S, Williams AD. The Health and Functional Benefits of Eccentric versus Concentric Exercise Training: A Systematic Review and Meta-Analysis. J Sports Sci Med. 2023 Jun 1;22(2):288-309. doi: 10.52082/jssm.2023.288. eCollection 2023 Jun.'}, {'pmid': '37814520', 'type': 'BACKGROUND', 'citation': 'Borot L, Pageaux B, Laroche D, Vergotte G, Lepers R, Perrey S. Eccentric cycling involves greater mental demand and cortical activation of the frontoparietal network. Scand J Med Sci Sports. 2024 Jan;34(1):e14517. doi: 10.1111/sms.14517. Epub 2023 Oct 9.'}, {'pmid': '28663378', 'type': 'BACKGROUND', 'citation': 'Penailillo L, Blazevich AJ, Nosaka K. Factors contributing to lower metabolic demand of eccentric compared with concentric cycling. J Appl Physiol (1985). 2017 Oct 1;123(4):884-893. doi: 10.1152/japplphysiol.00536.2016. Epub 2017 Jun 29.'}, {'pmid': '27899894', 'type': 'BACKGROUND', 'citation': 'Hoppeler H. Moderate Load Eccentric Exercise; A Distinct Novel Training Modality. Front Physiol. 2016 Nov 16;7:483. doi: 10.3389/fphys.2016.00483. eCollection 2016.'}, {'pmid': '19183097', 'type': 'BACKGROUND', 'citation': 'Marcus RL, Lastayo PC, Dibble LE, Hill L, McClain DA. Increased strength and physical performance with eccentric training in women with impaired glucose tolerance: a pilot study. J Womens Health (Larchmt). 2009 Feb;18(2):253-60. doi: 10.1089/jwh.2007.0669.'}, {'pmid': '30984032', 'type': 'BACKGROUND', 'citation': 'Clos P, Laroche D, Stapley PJ, Lepers R. Neuromuscular and Perceptual Responses to Sub-Maximal Eccentric Cycling. Front Physiol. 2019 Mar 28;10:354. doi: 10.3389/fphys.2019.00354. eCollection 2019.'}, {'pmid': '23475167', 'type': 'BACKGROUND', 'citation': 'Penailillo L, Blazevich A, Numazawa H, Nosaka K. Metabolic and muscle damage profiles of concentric versus repeated eccentric cycling. Med Sci Sports Exerc. 2013 Sep;45(9):1773-81. doi: 10.1249/MSS.0b013e31828f8a73.'}, {'pmid': '23823152', 'type': 'BACKGROUND', 'citation': 'LaStayo P, Marcus R, Dibble L, Frajacomo F, Lindstedt S. Eccentric exercise in rehabilitation: safety, feasibility, and application. J Appl Physiol (1985). 2014 Jun 1;116(11):1426-34. doi: 10.1152/japplphysiol.00008.2013. Epub 2013 Jul 3.'}, {'pmid': '12730250', 'type': 'BACKGROUND', 'citation': 'LaStayo PC, Ewy GA, Pierotti DD, Johns RK, Lindstedt S. The positive effects of negative work: increased muscle strength and decreased fall risk in a frail elderly population. J Gerontol A Biol Sci Med Sci. 2003 May;58(5):M419-24. doi: 10.1093/gerona/58.5.m419.'}, {'pmid': '34930480', 'type': 'BACKGROUND', 'citation': 'Kudiarasu C, Rohadhia W, Katsura Y, Koeda T, Singh F, Nosaka K. Eccentric-only versus concentric-only resistance training effects on biochemical and physiological parameters in patients with type 2 diabetes. BMC Sports Sci Med Rehabil. 2021 Dec 20;13(1):162. doi: 10.1186/s13102-021-00384-z.'}, {'pmid': '30222208', 'type': 'BACKGROUND', 'citation': 'Julian V, Thivel D, Miguet M, Pereira B, Costes F, Coudeyre E, Duclos M, Richard R. Eccentric cycling is more efficient in reducing fat mass than concentric cycling in adolescents with obesity. Scand J Med Sci Sports. 2019 Jan;29(1):4-15. doi: 10.1111/sms.13301. Epub 2018 Oct 4.'}, {'pmid': '37775653', 'type': 'BACKGROUND', 'citation': 'Szucs G, Pipicz M, Szabo MR, Csont T, Torok L, Csonka C. Effect of Eccentric Exercise on Metabolic Health in Diabetes and Obesity. Sports Med Open. 2023 Sep 29;9(1):91. doi: 10.1186/s40798-023-00596-2.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37293426/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to evaluate the long-term benefits of eccentric (ECC) cycling exercise on physiological responses, exercise capacity, and quality of life (QoL) in patients with type 2 diabetes mellitus (T2DM). The main questions it aims to answer are:\n\n* What are the effects of ECC cycling compared to concentric (CON) cycling on physiological responses, exercise capacity, and QoL in patients with T2DM?\n* What are the differential effects of moderate- and high-intensity ECC cycling compared to CON cycling on physiological responses, exercise capacity, and QoL in patients with T2DM?\n\nResearchers will compare moderate- and high-intensity ECC cycling to CON cycling (conventional cycling) to see if ECC cycling can be a viable alternative or complement to existing exercise protocols for managing T2DM.\n\nParticipants will:\n\n* Undergo pre-, mid-, and post-intervention assessment\n* Perform either moderate- or high-intensity ECC cycling or moderate intensity CON cycling according to group randomisation by the researcher.\n* Start with two familiarisation sessions prior to the actual cycling training.\n* Perform cycling exercise twice per week for 10 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male diagnosed with T2DM\n* Age 30 - 60 years old\n* Height ≥155cm (To ensure proper ergonomics, comfort and safety during cycling)\n* HbA1C level between 6-8%\n* No resistance exercise for ≤ 3 months before participating in the current study.\n* Physical inactivity (moderate to vigorous exercise ≤60 minutes weekly based on International Physical Activity Questionnaires-Short Form (IPAQ-SF))\n\nExclusion Criteria:\n\n* Acute illness or any foot ulcer, diabetic ulcer, retinopathy, kidney, musculoskeletal, cardiovascular, or neurological disorder that could impair exercise performance or pose a risk to participants during exercise.\n* Insulin injection'}, 'identificationModule': {'nctId': 'NCT07109102', 'briefTitle': 'Long-Term Benefits of Eccentric Cycling Exercise in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Exploring Long-Term Benefits of Eccentric Cycling Exercise on Physiological Responses, Exercise Capacity, and Quality of Life in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'USM/JEPeM/PP/25030323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate intensity eccentric cycling (MI-ECC)', 'interventionNames': ['Other: Moderate-intensity eccentric cycling']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity eccentric cycling (HI-ECC)', 'interventionNames': ['Other: High-intensity eccentric cycling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate intensity concentric cycling (MI-CON)', 'interventionNames': ['Other: Moderate-intensity concentric cycling']}], 'interventions': [{'name': 'Moderate-intensity eccentric cycling', 'type': 'OTHER', 'otherNames': ['MI-ECC'], 'description': '* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer.\n* The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).', 'armGroupLabels': ['Moderate intensity eccentric cycling (MI-ECC)']}, {'name': 'High-intensity eccentric cycling', 'type': 'OTHER', 'otherNames': ['HI-ECC'], 'description': '* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer.\n* The intensity will start at 80% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (80%-100% PPO).', 'armGroupLabels': ['High intensity eccentric cycling (HI-ECC)']}, {'name': 'Moderate-intensity concentric cycling', 'type': 'OTHER', 'otherNames': ['MI-CON'], 'description': '* This group will perform concentric cycling exercise twice per week for ten weeks using the Lode Excalibur sport ergometer.\n* The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).', 'armGroupLabels': ['Moderate intensity concentric cycling (MI-CON)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13200', 'city': 'Kepala Batas', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'contacts': [{'name': 'Rabiatul Adawiah Abdul Rahman', 'role': 'CONTACT', 'email': 'rabiatuladawiah3105@gmail.com', 'phone': '+60193709614'}], 'facility': 'Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam', 'geoPoint': {'lat': 5.51707, 'lon': 100.4265}}], 'centralContacts': [{'name': 'Syamimi Shamsuddin', 'role': 'CONTACT', 'email': 'syamimi.s@usm.my', 'phone': '+6045622024'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rabiatul Adawiah Abdul Rahman', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}