Effects of HMB and Rehabilitation Program in Athletes With Patellar Tendinopathy (HMB_TEN)

March 9, 2026 updated by: Universidad Complutense de Madrid

Effects of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Athletes With Patellar Tendinopathy

This randomized, double-blind, placebo-controlled clinical trial evaluates the effects of oral beta-hydroxy-beta-methylbutyrate (HMB) supplementation combined with an eccentric exercise and extracorporeal shockwave rehabilitation program on pain, tendon morphology, and neuromuscular performance in athletes with patellar tendinopathy.

Thirty athletes with a confirmed diagnosis of patellar tendinopathy are randomized to receive either HMB supplementation (3 g/day) or placebo during an 8-week rehabilitation program. Participants are evaluated at baseline, week 4, and week 8.

The primary outcome is pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Secondary outcomes include patellar tendon thickness measured by ultrasound imaging, countermovement jump (CMJ) performance, and neuromuscular performance variables derived from an incremental squat test using a linear position transducer.

The aim of the study is to determine whether HMB supplementation enhances clinical recovery and neuromuscular performance when combined with a standardized rehabilitation program compared with placebo.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patellar tendinopathy is a degenerative tendon disorder frequently observed in athletes involved in jumping and running sports. The condition is characterized by localized tendon pain, functional impairment, and structural alterations of the patellar tendon. Standard rehabilitation programs commonly include eccentric exercise protocols and extracorporeal shockwave therapy to promote tendon adaptation and pain reduction.

Beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of the amino acid leucine, has been associated with anti-catabolic effects and improved muscle recovery. HMB supplementation may potentially enhance neuromuscular adaptations and recovery during rehabilitation programs.

This study evaluates the effects of HMB supplementation when combined with a standardized rehabilitation program including eccentric exercise and extracorporeal shockwave therapy in athletes with patellar tendinopathy.

This randomized, double-blind, placebo-controlled clinical trial includes 30 athletes aged 18 to 49 years with clinically diagnosed patellar tendinopathy. Participants are randomly assigned to one of two groups:

HMB Group: Participants receive oral HMB supplementation (3 g/day) combined with eccentric exercise and extracorporeal shockwave therapy.

Placebo Group: Participants receive placebo capsules (sucrose) combined with the same eccentric exercise and extracorporeal shockwave therapy program.

The intervention lasts 8 weeks. Assessments are performed at baseline, week 4, and week 8.

The primary outcome measure is the VISA-P questionnaire, which assesses pain and functional limitations related to patellar tendinopathy. Secondary outcome measures include patellar tendon thickness measured by ultrasound imaging, countermovement jump (CMJ) performance, and neuromuscular performance variables obtained from an incremental squat test using a linear position transducer, including peak power, peak power relative to body mass, and mean velocity at peak power.

Exercise sessions follow a structured eccentric decline squat protocol combined with periodic extracorporeal shockwave therapy sessions using a Storz Medical MP100 device.

The objective of the study is to determine whether HMB supplementation improves clinical outcomes, tendon thickness, and neuromuscular performance compared with placebo when both groups follow the same rehabilitation program.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Contact

  • Name: Juan J Ramos-Álvarez, MD
  • Phone Number: +34 913941367
  • Email: jjramosa@ucm.es

Study Locations

  • Spain
    • Córdoba
      • Córdoba, Córdoba, Spain, 14007
        • Clínica Fisio-Agil

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 49 years
  • Clinical diagnosis of patellar tendinopathy confirmed by a physician and physiotherapist
  • Competitive athlete in sports involving repetitive knee loading (e.g., basketball, volleyball, handball, athletics)
  • Minimum training frequency of three sessions per week
  • No knee surgery within the previous 12 months
  • No nutritional supplementation within the previous 3 months
  • No injection therapy (analgesics or platelet-rich plasma) within the previous 12 months
  • Non-smoker
  • Signed informed consent

Exclusion Criteria:

  • Any musculoskeletal injury other than patellar tendinopathy affecting performance
  • Systemic disease affecting musculoskeletal function
  • Inability to comply with the rehabilitation or supplementation protocol

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMB Supplement + Rehabilitation Program
Participants receive beta-hydroxy-beta-methylbutyrate (HMB) supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.
Other: Eccentric exercise and extracorporeal shock wave therapy
Participants undergo a standardized rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.
Dietary supplement: Beta-hydroxy-beta-methylbutyrate (HMB)
Participants ingest 3 g/day of beta-hydroxy-beta-methylbutyrate (HMB) in capsule form, administered 60 minutes before each eccentric training session during the 8-week intervention period.
Placebo Comparator: Placebo + Rehabilitation Program
Participants receive placebo supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.
Other: Eccentric exercise and extracorporeal shock wave therapy
Participants undergo a standardized rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISA-P Score
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.
Baseline (PRE), Week 4 (INT), and Week 8 (POST)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patellar tendon thickness
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Change in patellar tendon thickness (mm) measured by ultrasound imaging using a standardized longitudinal scanning protocol
Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Countermovement Jump (CMJ)
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
hange in countermovement jump (CMJ) height measured in centimeters using a contact platform. Participants will perform three maximal attempts, and the highest value will be recorded
Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Peak Power (PP) during squat test
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Change in peak power (PP) measured in watts during an incremental squat test using a linear position transducer.
Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Peak Power Relative to Body Mass (PPkg)
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Change in peak power relative to body mass (PPkg) measured in watts per kilogram during an incremental squat test using a linear position transducer.
Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Mean Velocity at Peak Power (PPmv)
Time Frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Change in mean velocity at peak power (PPmv) measured in meters per second during an incremental squat test using a linear position transducer.
Baseline (PRE), Week 4 (INT), and Week 8 (POST)

Collaborators and Investigators

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

Sponsor

Universidad Complutense de Madrid

Collaborators

University of Seville
Universidad de Córdoba

Investigators

  • Principal Investigator: Juan J Ramos-Álvarez, MD, Universidad Complutense de Madrid

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

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/498-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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