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 volunteersQualifiers
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
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
Trial outcomes
Primary outcomes
Glycated haemoglobin (HbA1C)
Lipid profile
Maximal voluntary contraction (MVC)
isometric quadriceps peak torque (QPT) and isokinetic QPT
Exercise capacity
6-minute walk test (6-MWT)
Secondary outcomes
Electromyography (EMG) for muscle activity assessment
To assess quadriceps muscle activity (rectus femoris, vastus medialis oblique, and vastus lateralis) during maximal voluntary contraction.
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP),
Heart rate
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.
Sponsors and contacts
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