Effects of Velocity-Based Resistance Training on Renal Function and Metabolic Health in Kidney Transplant Recipients: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Serum creatinine (mg/dL) - change from baseline
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Experimental - Maximal Velocity Group
Participants will perform velocity-based resistance training at maximal intended concentric velocity. Training load will progress from 20% to 60% of 1RM. Each set will be terminated once a 20% loss of movement velocity is reached.
干预措施: Velocity-Based Resistance Training - Maximal Velocity Protocol (Other)
Submaximal Velocity Group
Participants will perform supervised velocity-based resistance training for 12 weeks, 3 sessions per week. Each repetition will be executed at approximately 50% of maximal concentric velocity. Training load will progress from 20% to 60% of 1RM, with sets completed according to a predetermined number of repetitions (20-30 depending on load).
干预措施: Velocity-Based Resistance Training - Submaximal Velocity Protocol (Other)
结局指标
主要结局
Serum creatinine (mg/dL) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Serum creatinine will be measured from venous blood samples processed in an external certified laboratory (IDIME, Bogotá). This parameter will serve as a biomarker of renal graft function.
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
The estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine using validated equations (CKD-EPI or MDRD). This measure will serve as the most sensitive indicator of renal graft function.
Blood urea nitrogen (BUN, mg/dL) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Blood urea nitrogen will be measured to monitor renal clearance capacity and metabolic status.
Serum Uric Acid (mg/dL)
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Serum uric acid will be measured as a biomarker of renal excretory capacity and cardiovascular risk.
HDL cholesterol (mg/dL) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
HDL cholesterol will be measured as a protective lipid biomarker inversely associated with metabolic and cardiovascular risk.
Triglycerides (mg/dL) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Serum triglycerides will be measured to evaluate metabolic health and risk of cardiovascular disease.
Fasting glucose (mg/dL) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Fasting blood glucose will be measured through enzymatic methods to evaluate glycemic control.
Waist circumference (cm) - change from baseline
时间窗: Baseline and week 13 (after completion of 12-week intervention)
Waist circumference will be measured at the narrowest point of the torso, midway between the lower margin of the ribs and the iliac crest, following ISAK recommendations. This anthropometric variable will serve as a key component of metabolic syndrome diagnosis.
Metabolic Risk Index (z-score composite)
时间窗: Baseline and week 13 (after completion of 12-week intervention)
A composite metabolic risk index will be calculated from triglycerides, LDL, HDL, glucose, and systolic/diastolic blood pressure values. Each variable will be standardized as z-scores; HDL will be multiplied by -1 due to its inverse relationship with cardiovascular risk. The final score will be the sum of standardized values.
次要结局
- Handgrip strength(Baseline and week 13 (after completion of 12-week intervention))
- Body Composition (fat percent, muscle percent, visceral fat)(Baseline and week 13 (after completion of 12-week intervention))
- Force-Velocity Profile(Baseline and week 13 (after completion of 12-week intervention))
- Body Height (cm)(Baseline and week 13 (after completion of 12-week intervention))
- Relative Handgrip Strength (kg/kg body weight)(Baseline and week 13 (after completion of 12-week intervention))
- Comorbidity and Immunosuppressive Therapy Questionnaire(Baseline and week 13 (after completion of 12-week intervention))
研究者
Jhonatan Camilo Peña Ibagon
Principal Investigator, PhD Candidate in Sport and Exercise Science and Technology"
Fundación Universitaria del Area Andina