Velocity-Based Resistance Training in Kidney Transplant Recipients (VBRTKIDNEY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Cardiovascular Risk Factors; Kidney Transplant Recipients
• Intervention / Treatment: Other: Velocity-Based Resistance Training - Maximal Velocity Protocol; Other: Velocity-Based Resistance Training - Submaximal Velocity Protocol

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).

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 0000
      • Recruiting
      • Colombia
      • Contact: Jhonatan C peña, Master in Physical Activity; Phone Number: 57 3125924821; Email: jpena69@areandina.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Active Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine (mg/dL) - change from baseline	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.	Baseline and week 13 (after completion of 12-week intervention)
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) - change from baseline	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.	Baseline and week 13 (after completion of 12-week intervention)
Blood urea nitrogen (BUN, mg/dL) - change from baseline	Blood urea nitrogen will be measured to monitor renal clearance capacity and metabolic status.	Baseline and week 13 (after completion of 12-week intervention)
Serum Uric Acid (mg/dL)	Serum uric acid will be measured as a biomarker of renal excretory capacity and cardiovascular risk.	Baseline and week 13 (after completion of 12-week intervention)
HDL cholesterol (mg/dL) - change from baseline	HDL cholesterol will be measured as a protective lipid biomarker inversely associated with metabolic and cardiovascular risk.	Baseline and week 13 (after completion of 12-week intervention)
Triglycerides (mg/dL) - change from baseline	Serum triglycerides will be measured to evaluate metabolic health and risk of cardiovascular disease.	Baseline and week 13 (after completion of 12-week intervention)
Fasting glucose (mg/dL) - change from baseline	Fasting blood glucose will be measured through enzymatic methods to evaluate glycemic control.	Baseline and week 13 (after completion of 12-week intervention)
Waist circumference (cm) - change from baseline	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.	Baseline and week 13 (after completion of 12-week intervention)
Metabolic Risk Index (z-score composite)	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.	Baseline and week 13 (after completion of 12-week intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Handgrip strength will be assessed using a digital dynamometer (Takei Scientific Instruments, Tokyo). Two trials per hand, best value recorded. This test reflects overall muscle strength.	Baseline and week 13 (after completion of 12-week intervention)
Body Composition (fat percent, muscle percent, visceral fat)	Body composition will be assessed using segmental bioelectrical impedance analysis (Tanita IRONMAN BC-1500). Measurements will include fat percentage, muscle percentage, and visceral fat.	Baseline and week 13 (after completion of 12-week intervention)
Force-Velocity Profile	:The force-velocity profile will be assessed using a linear encoder (T-Force) during three multi-joint exercises (bench press, squat, overhead press). The relationship between force and velocity will be calculated to estimate neuromuscular performance.	Baseline and week 13 (after completion of 12-week intervention)
Body Height (cm)	Body height will be measured with a digital stadiometer following the Frankfurt plane reference to ensure standardized posture.	Baseline and week 13 (after completion of 12-week intervention)
Relative Handgrip Strength (kg/kg body weight)	Relative handgrip strength will be calculated by dividing the maximum handgrip force by body weight to account for body size.	Baseline and week 13 (after completion of 12-week intervention)
Comorbidity and Immunosuppressive Therapy Questionnaire	A structured questionnaire will be used to record comorbidities and medication adherence. Adherence will be rated on a 5-point Likert scale (1 = never adherent, 5 = always adherent), where higher scores indicate better adherence.	Baseline and week 13 (after completion of 12-week intervention)

Collaborators and Investigators

• Sponsor: Fundación Universitaria del Area Andina

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• Fundación Universitaria del Área Andina

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise Intervention; Kidney Transplant; Renal Transplant; Metabolic Health; Velocity based resistance training; Glomerular Filtration Rate (eGFR)
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome
• Other Study ID Numbers: CV2025-IMED-B-13434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No