AzTrials
AzTrials

Type 2 Diabetes Mellitus (T2DM)NCT07109102

Long-Term Benefits of Eccentric Cycling Exercise in Patients With Type 2 Diabetes Mellitus

A study testing Moderate-intensity eccentric cycling, High-intensity eccentric cycling and Moderate-intensity concentric cycling in people with Type 2 Diabetes Mellitus (T2DM), run by Universiti Sains Malaysia at 1 site in Malaysia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 30 to 60 years, men only
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Moderate-intensity eccentric cycling, High-intensity eccentric cycling and Moderate-intensity concentric cycling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMalaysia
Study dates
Aug 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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))

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Syamimi Shamsuddin contact

+6045622024

syamimi.s@usm.my

Malaysia1 site
  • Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam

    Kepala Batas, Pulau Pinang, 13200

    Rabiatul Adawiah Abdul Rahman, +60193709614, rabiatuladawiah3105@gmail.com

Other trials in Malaysia

About this study

Official title: Exploring Long-Term Benefits of Eccentric Cycling Exercise on Physiological Responses, Exercise Capacity, and Quality of Life in Patients With Type 2 Diabetes Mellitus

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?
Read more

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.
Being tested
Moderate-intensity eccentric cycling, High-intensity eccentric cycling, Moderate-intensity concentric cycling
Keywords
Eccentric cycling, eccentric exercise, exercise capacity, quality of life, physiological responses, Type 2 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate-intensity eccentric cyclingOther

    Also called 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 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).
  • High-intensity eccentric cyclingOther

    Also called HI-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).
  • Moderate-intensity concentric cyclingOther

    Also called MI-CON

    • 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).
Study groups in NCT07109102
Study groupRoleWhat they receive
Moderate intensity eccentric cycling (MI-ECC)ExperimentalNot described
Receives: Other: Moderate-intensity eccentric cycling
High intensity eccentric cycling (HI-ECC)ExperimentalNot described
Receives: Other: High-intensity eccentric cycling
Moderate intensity concentric cycling (MI-CON)Active comparatorNot described
Receives: Other: Moderate-intensity concentric cycling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated haemoglobin (HbA1C)

    Measured: Baseline and post-intervention at 10 weeks

  2. Lipid profile

    Measured: Baseline and post-intervention at 10 weeks

  3. Maximal voluntary contraction (MVC)

    isometric quadriceps peak torque (QPT) and isokinetic QPT

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

  4. Exercise capacity

    6-minute walk test (6-MWT)

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

  5. 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

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

  6. Short Form-12 (SF-12) health survey

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

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

Secondary outcomes (9)
  1. Electromyography (EMG) for muscle activity assessment

    To assess quadriceps muscle activity (rectus femoris, vastus medialis oblique, and vastus lateralis) during maximal voluntary contraction.

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

  2. Blood pressure

    systolic blood pressure (SBP), diastolic blood pressure (DBP),

    Measured: Baseline and up to 10 weeks

  3. Heart rate

    Measured: Baseline and up to 10 weeks

  4. Borg Category-Ratio scale (Borg CR-10)

    The scale ranges from 0 (nothing at all) to 10 (extremely strong) to represent the participants' subjective feelings of breathlessness and leg fatigue.

    Measured: Every cycling training session from week 1 to week 10

  5. Body weight

    Body weight in kilograms (kg)

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

  6. Height

    Height in centimeters (cm)

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

  7. Body mass index (BMI)

    BMI is calculated as weight (kg) divided by height (m²).

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

  8. Body circumference

    Measure the waist circumference (WC), hip circumference (HC), and thigh circumference (TC) in centimetres with a measuring tape.

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

  9. The short version of the physical activity enjoyment scale (PACES-S)

    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.

    Measured: Mid-intervention (6 weeks), and post-intervention (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is an open-label, single-centre, parallel-group, three-arm, randomised controlled study.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109102
Sponsor's protocol ID
USM/JEPeM/PP/25030323
Status last verified
Jul 2025
First submitted
29 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37293426
  • 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.

    PubMed 37814520
  • 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.

    PubMed 28663378
  • 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.

    PubMed 27899894
  • 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.

    PubMed 19183097
  • 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.

    PubMed 30984032
  • 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.

    PubMed 23475167
  • 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.

    PubMed 23823152
  • 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.

    PubMed 12730250
  • 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.

    PubMed 34930480
  • 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.

    PubMed 30222208
  • 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.

    PubMed 37775653

Questions about this trial

What is this clinical trial studying?

A study testing Moderate-intensity eccentric cycling, High-intensity eccentric cycling and Moderate-intensity concentric cycling in people with Type 2 Diabetes Mellitus (T2DM), run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Syamimi Shamsuddin (+6045622024, syamimi.s@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated haemoglobin (HbA1C) (time frame: Baseline and post-intervention at 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07109102, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in