Velocity-Based Resistance Training in Kidney Transplant Recipients

Official title

Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Randomized Controlled Trial

Overview

This randomized controlled trial aims to evaluate the effects of velocity-based resistance training on renal function and metabolic health in kidney transplant recipients. Participants will be randomized into two groups performing resistance training at different execution velocities (maximal intended vs. submaximal controlled). The intervention will last 12 weeks and include multi-joint exercises (squat, bench press, military press). Primary outcomes include renal function (serum creatinine, eGFR, blood urea nitrogen, uric acid) and metabolic markers (HDL, triglycerides, glucose, waist circumference, blood pressure). Secondary outcomes include muscle strength, force-velocity profile, anthropometry, physical activity, fitness perception, and adherence to immunosuppressive medication.

Detailed description

This randomized controlled trial will examine the physiological and metabolic responses to different resistance training velocities in kidney transplant recipients. Participants will be randomized to perform either maximal-velocity or submaximal-velocity resistance exercises for 12 weeks. Each session will include multi-joint movements (bench press, squat, overhead press) using a Smith machine. Training loads will be individualized (20-60% 1RM) and monitored using a linear encoder to control velocity loss. Primary endpoints are renal function and metabolic health markers, while secondary outcomes include neuromuscular performance and adherence to immunosuppressive therapy. The study has received ethics approval from Fundación Universitaria del Área Andina (Acta 15, April 22, 2025).

Interventions

• Other Velocity-Based Resistance Training - Submaximal Velocity Protocol
  A 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at \~50% of maximal concentric velocity, with sets completed according to predetermined repetitions (20-30 depending on load, 20-60% 1RM).
• Other Velocity-Based Resistance Training - Maximal Velocity Protocol
  A 12-week supervised resistance training program performed 3 sessions per week. Exercises will include bench press, squat, and shoulder press in Smith machine. Participants will execute each repetition at maximal concentric velocity, with sets terminated at 20% velocity loss. Training loads will increase progressively (20-60% 1RM).

Primary outcome measures

• Serum creatinine (mg/dL) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Blood urea nitrogen (BUN, mg/dL) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Serum Uric Acid (mg/dL) [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• HDL cholesterol (mg/dL) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Triglycerides (mg/dL) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Fasting glucose (mg/dL) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Waist circumference (cm) - change from baseline [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Metabolic Risk Index (z-score composite) [Time frame: Baseline and week 13 (after completion of 12-week intervention)]

Secondary outcome measures (6)

• Handgrip strength [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Body Composition (fat percent, muscle percent, visceral fat) [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Force-Velocity Profile [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Body Height (cm) [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Relative Handgrip Strength (kg/kg body weight) [Time frame: Baseline and week 13 (after completion of 12-week intervention)]
• Comorbidity and Immunosuppressive Therapy Questionnaire [Time frame: Baseline and week 13 (after completion of 12-week intervention)]

Eligibility criteria

Inclusion criteria

• Men and women aged 18 to 50 years.
• Kidney transplant performed ≥12 months before enrollment.
• Stable graft function in the previous 6 months (serum creatinine < 1.5 mg/dL, no rejection episodes).
• Written medical clearance from a nephrologist to perform moderate-to-vigorous physical activity.
• Signed informed consent.

Exclusion criteria

• Active autoimmune disorders.
• Recent coronary disease (≤6 months).
• Severe musculoskeletal limitations incompatible with resistance training.
• Diagnosis of diabetes mellitus (pre- or post-transplant).
• Current active infection.
• Use of immunosuppressive drugs with contraindications for exercise (e.g., mTOR inhibitors at baseline).

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

Single blind

Primary purpose

Treatment

Study locations

Colombia · 1 center

• Colombia — Bogotá

Publications

• Michou V, Nikodimopoulou M, Liakopoulos V, Anifanti M, Papagianni A, Zembekakis P, Deligiannis A, Kouidi E. Home-Based Exercise Training and Cardiac Autonomic Neuropathy in Kidney Transplant Recipients with Type-II Diabetes Mellitus. Life (Basel). 2023 Jun 14;13(6):1394. doi: 10.3390/life13061394. PMID 37374177
• Pena JC, Sanchez-Guette L, Lombo C, Pinto E, Collazos C, Tovar B, Bonilla DA, Cardozo LA, Tellez LA. Characterization of Load Components in Resistance Training Programs for Kidney Transplant Recipients: A Scoping Review. Sports (Basel). 2025 May 19;13(5):153. doi: 10.3390/sports13050153. PMID 40423289
• Lima PS, de Campos AS, de Faria Neto O, Ferreira TCA, Amorim CEN, Stone WJ, Prestes J, Garcia AMC, Urtado CB. Effects of Combined Resistance Plus Aerobic Training on Body Composition, Muscle Strength, Aerobic Capacity, and Renal Function in Kidney Transplantation Subjects. J Strength Cond Res. 2021 Nov 1;35(11):3243-3250. doi: 10.1519/JSC.0000000000003274. PMID 31714457
• Hernandez Sanchez S, Carrero JJ, Morales JS, Ruiz JR. Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Scand J Med Sci Sports. 2021 Feb;31(2):473-479. doi: 10.1111/sms.13853. Epub 2020 Oct 23. PMID 33038051
• Pena Ibagon JC, Vasquez Osorio F, Collazos Morales CA, Tovar BE, Martin WF, Pardo YR, Tellez LA. Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 10;15:e94010. doi: 10.2196/94010. PMID 42430723

Identifiers

NCT: NCT07370727 · CV2025-IMED-B-13434

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗