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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-60
SponsorUniversiti Sains Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Moderate-intensity eccentric cycling

    Other intervention

    * 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 cycling

    Other intervention

    * 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 cycling

    Other intervention

    * 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).

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Moderate intensity eccentric cycling (MI-ECC)Experimental treatment 1 intervention
Group B: High intensity eccentric cycling (HI-ECC)Experimental treatment 1 intervention
Group C: Moderate intensity concentric cycling (MI-CON)Active comparator 1 intervention

Trial outcomes

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)

isometric quadriceps peak torque (QPT) and isokinetic QPT

Time frame
Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks).
4

Exercise capacity

6-minute walk test (6-MWT)

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

Secondary outcomes

1

Electromyography (EMG) for muscle activity assessment

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

Time frame
Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)
2

Blood pressure

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

Time frame
Baseline and up to 10 weeks
3

Heart rate

Time frame
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.

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

Other outcomes

Sponsors and contacts

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