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

January 21, 2026 updated by: Jhonatan Camilo Peña Ibagon, Fundación Universitaria del Area Andina

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 0000
        • Recruiting
        • Colombia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum creatinine (mg/dL) - change from baseline
Time Frame: 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.
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)
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
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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)
Time Frame: 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.
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)
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
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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
Time Frame: 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.
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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)
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
: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)
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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)
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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
Time Frame: Baseline and week 13 (after completion of 12-week intervention)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Universitaria del Area Andina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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