Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Eccentric cycling, eccentric exercise, exercise capacity, quality of life, physiological responses, Type 2 diabetes mellitus
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.
Interventions
OTHERModerate-intensity eccentric cycling
* 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).
OTHERHigh-intensity eccentric cycling
* 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).
OTHERModerate-intensity concentric cycling
* 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).
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study is an open-label, single-centre, parallel-group, three-arm, randomised controlled study.
Eligibility
Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated haemoglobin (HbA1C) | Baseline and post-intervention at 10 weeks | — |
| Lipid profile | Baseline and post-intervention at 10 weeks | — |
| Maximal voluntary contraction (MVC) | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks). | isometric quadriceps peak torque (QPT) and isokinetic QPT |
| Exercise capacity | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks) | 6-minute walk test (6-MWT) |
| 13-item Revised Version of Diabetes Quality of Life (RV-DQOL13) | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks) | Scores range from 13 to 65, with higher scores reflecting reduced quality of life |
| Short Form-12 (SF-12) health survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks) | BMI is calculated as weight (kg) divided by height (m²). |
| Electromyography (EMG) for muscle activity assessment | 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. |
| The short version of the physical activity enjoyment scale (PACES-S) | 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. |
| Body circumference | 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. |
| Blood pressure | Baseline and up to 10 weeks | systolic blood pressure (SBP), diastolic blood pressure (DBP), |
| 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 | The scale ranges from 0 (nothing at all) to 10 (extremely strong) to represent the participants' subjective feelings of breathlessness and leg fatigue. |
| Body weight | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks) | Body weight in kilograms (kg) |
| Height | Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks) | Height in centimeters (cm) |
Countries
Malaysia
Contacts
Primary ContactSyamimi Shamsuddin
Outcome results
None listed