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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT07109102
• Lead Sponsor: Universiti Sains Malaysia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study Start: 2025-08-01
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-05
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin (HbA1C)	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
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
Lipid profile	Baseline and post-intervention at 10 weeks
Exercise capacity	Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)	6-minute walk test (6-MWT)
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 Outcome Measures

Name	Time	Method
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)
Body mass index (BMI)	Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)	BMI is calculated as weight (kg) divided by height (m²).
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.
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.
Blood pressure	Baseline and up to 10 weeks	systolic blood pressure (SBP), diastolic blood pressure (DBP),
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.

Trial Locations

Locations (1)

Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam; 🇲🇾 Kepala Batas, Pulau Pinang, Malaysia