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

U

Universiti Sains Malaysia

Status

Not yet enrolling

Conditions

Type 2 Diabetes Mellitus (T2DM)

Treatments

Other: High-intensity eccentric cycling
Other: Moderate-intensity eccentric cycling
Other: Moderate-intensity concentric cycling

Study type

Interventional

Funder types

Other

Identifiers

NCT07109102
USM/JEPeM/PP/25030323

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Moderate intensity eccentric cycling (MI-ECC)
Experimental group
Treatment:
Other: Moderate-intensity eccentric cycling
High intensity eccentric cycling (HI-ECC)
Experimental group
Treatment:
Other: High-intensity eccentric cycling
Moderate intensity concentric cycling (MI-CON)
Active Comparator group
Treatment:
Other: Moderate-intensity concentric cycling

Trial contacts and locations

1

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Central trial contact

Syamimi Shamsuddin

Data sourced from clinicaltrials.gov

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