NCT07109102

Brief Summary

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:

  • What are the effects of ECC cycling compared to concentric (CON) cycling on physiological responses, exercise capacity, and QoL in patients with T2DM?
  • 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? Researchers 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. Participants will:
  • Undergo pre-, mid-, and post-intervention assessment
  • Perform either moderate- or high-intensity ECC cycling or moderate intensity CON cycling according to group randomisation by the researcher.
  • Start with two familiarisation sessions prior to the actual cycling training.
  • Perform cycling exercise twice per week for 10 weeks.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress87%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 29, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Eccentric cyclingeccentric exerciseexercise capacityquality of lifephysiological responsesType 2 diabetes mellitus

Outcome Measures

Primary Outcomes (6)

  • Glycated haemoglobin (HbA1C)

    Baseline and post-intervention at 10 weeks

  • Lipid profile

    Baseline and post-intervention at 10 weeks

  • Maximal voluntary contraction (MVC)

    isometric quadriceps peak torque (QPT) and isokinetic QPT

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks).

  • Exercise capacity

    6-minute walk test (6-MWT)

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)

  • 13-item Revised Version of Diabetes Quality of Life (RV-DQOL13)

    Scores range from 13 to 65, with higher scores reflecting reduced quality of life

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)

  • Short Form-12 (SF-12) health survey

    Scoring ranges from 0 to 100, with higher scores indicating better physical and mental health.

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)

Secondary Outcomes (9)

  • Electromyography (EMG) for muscle activity assessment

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)

  • Blood pressure

    Baseline and up to 10 weeks

  • Heart rate

    Baseline and up to 10 weeks

  • Borg Category-Ratio scale (Borg CR-10)

    Every cycling training session from week 1 to week 10

  • Body weight

    Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)

  • +4 more secondary outcomes

Study Arms (3)

Moderate intensity eccentric cycling (MI-ECC)

EXPERIMENTAL
Other: Moderate-intensity eccentric cycling

High intensity eccentric cycling (HI-ECC)

EXPERIMENTAL
Other: High-intensity eccentric cycling

Moderate intensity concentric cycling (MI-CON)

ACTIVE COMPARATOR
Other: Moderate-intensity concentric cycling

Interventions

* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer. * The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test. * The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).

Also known as: MI-ECC
Moderate intensity eccentric cycling (MI-ECC)

* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer. * The intensity will start at 80% of the peak power output (PPO) of the incremental concentric cycling test. * The intensity will progressively increase by 5% of PPO every 2 weeks (80%-100% PPO).

Also known as: HI-ECC
High intensity eccentric cycling (HI-ECC)

* This group will perform concentric cycling exercise twice per week for ten weeks using the Lode Excalibur sport ergometer. * The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test. * The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).

Also known as: MI-CON
Moderate intensity concentric cycling (MI-CON)

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male diagnosed with T2DM
  • Age 30 - 60 years old
  • Height ≥155cm (To ensure proper ergonomics, comfort and safety during cycling)
  • HbA1C level between 6-8%
  • No resistance exercise for ≤ 3 months before participating in the current study.
  • Physical inactivity (moderate to vigorous exercise ≤60 minutes weekly based on International Physical Activity Questionnaires-Short Form (IPAQ-SF))

You may not qualify if:

  • 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.
  • Insulin injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Related Publications (12)

  • 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: 37293426BACKGROUND
  • 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: 37814520BACKGROUND
  • 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: 28663378BACKGROUND
  • 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: 27899894BACKGROUND
  • 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: 19183097BACKGROUND
  • 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: 30984032BACKGROUND
  • 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: 23475167BACKGROUND
  • 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: 23823152BACKGROUND
  • 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: 12730250BACKGROUND
  • 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: 34930480BACKGROUND
  • 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: 30222208BACKGROUND
  • 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.

    PMID: 37775653BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Syamimi Shamsuddin

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is an open-label, single-centre, parallel-group, three-arm, randomised controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 7, 2025

Study Start

August 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations