Velocity-Based Resistance Training in Kidney Transplant Recipients

NCT07370727 | Recruiting

• 1 other identifier: CV2025-IMED-B-13434
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant Recipients; Metabolic Syndrome; Cardiovascular Risk Factors

Keywords

Kidney Transplant; Renal Transplant; Velocity based resistance training; Metabolic Health; Exercise Intervention; Glomerular Filtration Rate (eGFR)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• 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)

Study Arms (2)

Experimental - Maximal Velocity Group

EXPERIMENTAL

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

Submaximal Velocity Group

ACTIVE COMPARATOR

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

Interventions

Velocity-Based Resistance Training - Submaximal Velocity Protocol OTHER

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).

Submaximal Velocity Group

Velocity-Based Resistance Training - Maximal Velocity Protocol OTHER

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).

Experimental - Maximal Velocity Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Universitaria del Area Andina: lead

Study Sites (1)

Colombia

Bogotá, Bogota D.C., 0000, Colombia

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Fundación Universitaria del Área Andina

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate in Sport and Exercise Science and Technology"

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 27, 2026
• Study Start: October 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CO (1)