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NCT Number: NCT07109102

Long-Term Benefits of Eccentric Cycling Exercise 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?

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location contact

Rabiatul Adawiah Abdul Rahman

CONTACT

[email protected]

+60193709614

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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))

Exclusion criteria

  • 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

Treatment and study plan

Moderate-intensity eccentric cycling

Other
  • 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).

Other names: MI-ECC

High-intensity eccentric cycling

Other
  • 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).

Other names: HI-ECC

Moderate-intensity concentric cycling

Other
  • 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).

Other names: MI-CON

Primary outcomes

  1. Glycated haemoglobin (HbA1C)

    Time frame: Baseline and post-intervention at 10 weeks

  2. Lipid profile

    Time frame: Baseline and post-intervention at 10 weeks

  3. Maximal voluntary contraction (MVC)

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

    isometric quadriceps peak torque (QPT) and isokinetic QPT

  4. Exercise capacity

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

    6-minute walk test (6-MWT)

  5. 13-item Revised Version of Diabetes Quality of Life (RV-DQOL13)

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

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

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

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

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

Secondary outcomes

  1. Electromyography (EMG) for muscle activity assessment

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

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

  2. Blood pressure

    Time frame: Baseline and up to 10 weeks

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

  3. Heart rate

    Time frame: Baseline and up to 10 weeks

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

    Time frame: Every cycling training session from week 1 to week 10

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

  5. Body weight

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

    Body weight in kilograms (kg)

  6. Height

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

    Height in centimeters (cm)

  7. Body mass index (BMI)

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

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

  8. Body circumference

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

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

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Syamimi Shamsuddin

CONTACT

[email protected]

+6045622024

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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