Velocity-Based Resistance Training in Kidney Transplant Recipients

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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).
• Другое 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).

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• Colombia — Bogotá

Публикации

• 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

Идентификаторы

NCT: NCT07370727 · CV2025-IMED-B-13434

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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