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

Official title

Exploring Long-Term Benefits of Eccentric Cycling Exercise on Physiological Responses, Exercise Capacity, and Quality of Life in Patients With Type 2 Diabetes Mellitus

Overview

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

• Other Moderate-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).
• Other High-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).
• Other Moderate-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).

Primary outcome measures

• Glycated haemoglobin (HbA1C) [Time frame: Baseline and post-intervention at 10 weeks]
• Lipid profile [Time frame: Baseline and post-intervention at 10 weeks]
• Maximal voluntary contraction (MVC) [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks).]
• Exercise capacity [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• 13-item Revised Version of Diabetes Quality of Life (RV-DQOL13) [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• Short Form-12 (SF-12) health survey [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]

Secondary outcome measures (9)

• Electromyography (EMG) for muscle activity assessment [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• Blood pressure [Time frame: Baseline and up to 10 weeks]
• Heart rate [Time frame: Baseline and up to 10 weeks]
• Borg Category-Ratio scale (Borg CR-10) [Time frame: Every cycling training session from week 1 to week 10]
• Body weight [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• Height [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• Body mass index (BMI) [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• Body circumference [Time frame: Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)]
• The short version of the physical activity enjoyment scale (PACES-S) [Time frame: Mid-intervention (6 weeks), and post-intervention (10 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Malaysia · 1 center

• Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam — Kepala Batas

Publications

• Ansari M, Hardcastle S, Myers S, Williams AD. The Health and Functional Benefits of Eccentric versus Concentric Exercise Training: A Systematic Review and Meta-Analysis. J Sports Sci Med. 2023 Jun 1;22(2):288-309. doi: 10.52082/jssm.2023.288. eCollection 2023 Jun. PMID 37293426
• Borot L, Pageaux B, Laroche D, Vergotte G, Lepers R, Perrey S. Eccentric cycling involves greater mental demand and cortical activation of the frontoparietal network. Scand J Med Sci Sports. 2024 Jan;34(1):e14517. doi: 10.1111/sms.14517. Epub 2023 Oct 9. PMID 37814520
• Penailillo L, Blazevich AJ, Nosaka K. Factors contributing to lower metabolic demand of eccentric compared with concentric cycling. J Appl Physiol (1985). 2017 Oct 1;123(4):884-893. doi: 10.1152/japplphysiol.00536.2016. Epub 2017 Jun 29. PMID 28663378
• Hoppeler H. Moderate Load Eccentric Exercise; A Distinct Novel Training Modality. Front Physiol. 2016 Nov 16;7:483. doi: 10.3389/fphys.2016.00483. eCollection 2016. PMID 27899894
• Marcus RL, Lastayo PC, Dibble LE, Hill L, McClain DA. Increased strength and physical performance with eccentric training in women with impaired glucose tolerance: a pilot study. J Womens Health (Larchmt). 2009 Feb;18(2):253-60. doi: 10.1089/jwh.2007.0669. PMID 19183097
• Clos P, Laroche D, Stapley PJ, Lepers R. Neuromuscular and Perceptual Responses to Sub-Maximal Eccentric Cycling. Front Physiol. 2019 Mar 28;10:354. doi: 10.3389/fphys.2019.00354. eCollection 2019. PMID 30984032
• Penailillo L, Blazevich A, Numazawa H, Nosaka K. Metabolic and muscle damage profiles of concentric versus repeated eccentric cycling. Med Sci Sports Exerc. 2013 Sep;45(9):1773-81. doi: 10.1249/MSS.0b013e31828f8a73. PMID 23475167
• LaStayo P, Marcus R, Dibble L, Frajacomo F, Lindstedt S. Eccentric exercise in rehabilitation: safety, feasibility, and application. J Appl Physiol (1985). 2014 Jun 1;116(11):1426-34. doi: 10.1152/japplphysiol.00008.2013. Epub 2013 Jul 3. PMID 23823152

Identifiers

NCT: NCT07109102 · USM/JEPeM/PP/25030323

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗