Patellar TendinopathyHMB_TENNCT07466407
Effects of HMB and Rehabilitation Program in Athletes With Patellar Tendinopathy
A study testing Eccentric exercise and extracorporeal shock wave therapy and Beta-hydroxy-beta-methylbutyrate (HMB) in people with Patellar Tendinopathy, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Eccentric exercise and extracorporeal shock wave therapy and Beta-hydroxy-beta-methylbutyrate (HMB)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- No injection therapy (analgesics or platelet-rich plasma) within the previous 12 months
- Non-smoker
- Signed informed consent
Who cannot join
- Any musculoskeletal injury other than patellar tendinopathy affecting performance
- Systemic disease affecting musculoskeletal function
- Inability to comply with the rehabilitation or supplementation protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Patellar Tendinopathy
- Being tested
- Eccentric exercise and extracorporeal shock wave therapy, Beta-hydroxy-beta-methylbutyrate (HMB)
- Keywords
- Tendinopathy, HMB, Rehabilitation, Knee pain, Sports injury, Nutritional supplement, Beta-hydroxy-beta-methylbutyrate
- Medical subject headings
- Tendinopathy, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exercise and extracorporeal shock wave therapyOther
Participants undergo a standardized rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.
Beta-hydroxy-beta-methylbutyrate (HMB)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| HMB Supplement + Rehabilitation Program | Experimental | Participants receive beta-hydroxy-beta-methylbutyrate (HMB) supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy. Receives: Other: Eccentric exercise and extracorporeal shock wave therapy; Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB) |
| Placebo + Rehabilitation Program | Placebo comparator | Participants receive placebo supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy. Receives: Other: Eccentric exercise and extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-P Score
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.
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Secondary outcomes (5)
Patellar tendon thickness
Change in patellar tendon thickness (mm) measured by ultrasound imaging using a standardized longitudinal scanning protocol
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Countermovement Jump (CMJ)
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
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Peak Power (PP) during squat test
Change in peak power (PP) measured in watts during an incremental squat test using a linear position transducer.
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Peak Power Relative to Body Mass (PPkg)
Change in peak power relative to body mass (PPkg) measured in watts per kilogram during an incremental squat test using a linear position transducer.
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Mean Velocity at Peak Power (PPmv)
Change in mean velocity at peak power (PPmv) measured in meters per second during an incremental squat test using a linear position transducer.
Measured: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study followed a randomized, double-blind, parallel-group design. Thirty athletes with diagnosed patellar tendinopathy were randomly assigned to one of two groups: (1) HMB supplementation plus rehabilitation program, or (2) placebo supplementation plus the same rehabilitation program. The intervention period lasted 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Córdoba, University of Seville
- Responsible party
- Sponsor
- Investigators
- Juan J Ramos-Álvarez, MD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466407
- Sponsor's protocol ID
- 25/498-E
- Acronym
- HMB_TEN
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Gomez A, Jurado-Castro JM, Mata F, Sanchez-Oliver AJ, Dominguez R. Effects of beta-Hydroxy beta-Methylbutyric Supplementation in Combination with Conservative Non-Invasive Treatments in Athletes with Patellar Tendinopathy: A Pilot Study. Int J Environ Res Public Health. 2022 Jan 1;19(1):471. doi: 10.3390/ijerph19010471.
PubMed 35010730
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Athletes With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT07466407
- Acronym / sponsor ID
- HMB_TEN / 25/498-E
- Conditions
- Patellar Tendinopathy
- Keywords
- Tendinopathy, HMB, Rehabilitation, Knee pain, Sports injury, Nutritional supplement, Beta-hydroxy-beta-methylbutyrate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Universidad de Córdoba, University of Seville
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study followed a randomized, double-blind, parallel-group design. Thirty athletes with diagnosed patellar tendinopathy were randomly assigned to one of two groups: (1) HMB supplementation plus rehabilitation program, or (2) placebo supplementation plus the same rehabilitation program. The intervention period lasted 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| HMB Supplement + Rehabilitation Program | Experimental | Other: Eccentric exercise and extracorporeal shock wave therapy, Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB)Participants receive beta-hydroxy-beta-methylbutyrate (HMB) supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy. |
| Placebo + Rehabilitation Program | Placebo comparator | Other: Eccentric exercise and extracorporeal shock wave therapyParticipants receive placebo supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Any musculoskeletal injury other than patellar tendinopathy affecting performance
- Systemic disease affecting musculoskeletal function
- Inability to comply with the rehabilitation or supplementation protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exercise and extracorporeal shock wave therapyParticipants undergo a standardized rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy. | Other | HMB Supplement + Rehabilitation Program, Placebo + Rehabilitation Program |
| 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. | Dietary supplement | HMB Supplement + Rehabilitation Program |
Primary outcome
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.
5 secondary outcomes
Patellar tendon thickness
Time frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)
Countermovement Jump (CMJ)
Time frame: 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)
Peak Power Relative to Body Mass (PPkg)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 35010730Sanchez-Gomez A, Jurado-Castro JM, Mata F, Sanchez-Oliver AJ, Dominguez R. Effects of beta-Hydroxy beta-Methylbutyric Supplementation in Combination with Conservative Non-Invasive Treatments in Athletes with Patellar Tendinopathy: A Pilot Study. Int J Environ Res Public Health. 2022 Jan 1;19(1):471. doi: 10.3390/ijerph19010471.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan J Ramos-Álvarez, MD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise and extracorporeal shock wave therapy and Beta-hydroxy-beta-methylbutyrate (HMB) in people with Patellar Tendinopathy, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan J Ramos-Álvarez, MD (+34 913941367, jjramosa@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISA-P Score (time frame: Baseline (PRE), Week 4 (INT), and Week 8 (POST)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.