CreatineCREATINE_TENNCT06482619
Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy
A study testing Creatine supplementation in people with Creatine and Patellar Tendinopathy, run by Universidad Pontificia Comillas at 1 site in Spain.
Trial summary
The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching… Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Creatine, Patellar Tendinopathy
- What is being tested?
- Creatine supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Athletes diagnosed with patellar tendinopathy by sport medicine doctor.
- Age (>18 years and <49 years).
- To be federated in a sport modality that involves high repetitive impact in the knee; iii) to train more than 3 sessions weekly.
- Not having undergone knee surgery.
- Not having undergone any infiltration of analgesics or platelet-rich plasma during the last year.
- Not intake any sport performance supplement in the previous year;
- Smoker person.
Who cannot join
- Not being diagnosed with patellar tendinopathy by a doctor
- Age (<18 years and > 50 years).
- Involved in a sport modality without high repetitive impacts during sports activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Creatine Supplementation in Combination With a Rehabilitation Program Physical in Athletes With Patellar Tendinopathy
The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.
Read the detailed description
Nutrition could play an important role in the rehabilitation from sport injuries. This afirmation is based on studies that analyze the impact of different dietary supplements along immobilization periods, stablishing that creatine, leucine and omega-3 fatty acid supplementation could ameliorate muscle loss, while creatine could potentiate the hypertrophy along the rehabilitation process. For this reason, the aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.
- Conditions
- Creatine, Patellar Tendinopathy
- Being tested
- Creatine supplementation, Placebo
- Keywords
- Ergogenic aid, Dietary, Injury, Nutrition, Sport Nutrition
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine supplementationDietary supplement
The supplements were provided in capsules of 1 g of red color not transparent Guinama S.L.U, 0044634, La Pobla de Valbona, Spain) which were prepared with a Capsunorm 2000 semi-automatic manual capsule filling machine (Miranda del Ebro, Spain). Capsules contained creatine monohidrate (Creapure, Crown Sport Nutrition, Arnedo, Spain)
PlaceboDietary supplement
The supplements were provided in capsules of 1 g of red color not transparent Guinama S.L.U, 0044634, La Pobla de Valbona, Spain) which were prepared with a Capsunorm 2000 semi-automatic manual capsule filling machine (Miranda del Ebro, Spain). Capsules contained placebo (i.e., sucrose)
| Study group | Role | What they receive |
|---|---|---|
| Creatine supplementation | Experimental | Creatine monohydrate (Creapure®, Crown Sport Nutrition, Arnedo, Spain) ingested 3 capsules daily (3 g/day) Receives: Dietary Supplement: Creatine supplementation |
| Placebo supplementation | Placebo comparator | Sucrose ingested 3 capsules daily (3 g/day) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
For assessing pain, the Victorian Institute for Sports Assessment - Patella (VISA - P), the most widely used patient-reported outcome measure (including symptom severity), was administered . The VISA - P will be scored with a maximum of 100 points and the higher scores indicate better function, and it shows sensible to identify improvements in therapeutic interventions among patients with tendinopathies.
Measured: 8-weeks
Tendon thickness.
Thickness Tendon of the injuried knee/s was analyzed with ultrasound (GE VENUE 40, Portable Ultrasound, CA, USA), and a linear translator. Participants were positioned supine with a 30º knee flexion (using a roller under the knees), reducing the "locking" of the patella in the femur as in full extension. Ultrasound gel was applied and evaluated by placing the probe longitudinally; in pathological tendons it is the only way to determine the distance of the measurement point from the insertion of the tendon. Thus, subsequent measurements were always made from the same point.
Measured: 8-weeks
Secondary outcomes (1)
Neuromuscular function
Participants performed a neuromuscular test battery consisted in measuring vertical jump capacity (i.e., countermovement jump) and knee extension muscle strength muscular strength in a knee extension machine (Selection Leg Extension, Technogym, Cesena, Italy) with a 5 maximum number of repetitions (5-RM)
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2021
- Primary completion30 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CreatineStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Córdoba, University of Bologna, Technical University of Madrid, Lavras University
- Responsible party
- Sponsor
- Investigators
- Angela Sánchez-Gómez, PhD, Principal investigator, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482619
- Sponsor's protocol ID
- UPComillas
- Acronym
- CREATINE_TEN
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation in Combination With a Rehabilitation Program Physical in Athletes With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT06482619
- Acronym / sponsor ID
- CREATINE_TEN / UPComillas
- Conditions
- Creatine, Patellar Tendinopathy
- Keywords
- Ergogenic aid, Dietary, Injury, Nutrition, Sport Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Collaborators
- Universidad de Córdoba, University of Bologna, Technical University of Madrid, Lavras University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 Jul 2024 (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.
The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.
Detailed description
Nutrition could play an important role in the rehabilitation from sport injuries. This afirmation is based on studies that analyze the impact of different dietary supplements along immobilization periods, stablishing that creatine, leucine and omega-3 fatty acid supplementation could ameliorate muscle loss, while creatine could potentiate the hypertrophy along the rehabilitation process. For this reason, the aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine supplementation | Experimental | Dietary Supplement: Creatine supplementationCreatine monohydrate (Creapure®, Crown Sport Nutrition, Arnedo, Spain) ingested 3 capsules daily (3 g/day) |
| Placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboSucrose ingested 3 capsules daily (3 g/day) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Athletes diagnosed with patellar tendinopathy by sport medicine doctor.
- Age (>18 years and <49 years).
- To be federated in a sport modality that involves high repetitive impact in the knee; iii) to train more than 3 sessions weekly.
- Not having undergone knee surgery.
- Not having undergone any infiltration of analgesics or platelet-rich plasma during the last year.
Key exclusion criteria (3 listed)
- Not being diagnosed with patellar tendinopathy by a doctor
- Age (<18 years and > 50 years).
- Involved in a sport modality without high repetitive impacts during sports activity.
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 |
|---|---|---|
| Creatine supplementationThe supplements were provided in capsules of 1 g of red color not transparent Guinama S.L.U, 0044634, La Pobla de Valbona, Spain) which were prepared with a Capsunorm 2000 semi-automatic manual capsule filling machine (Miranda del Ebro, Spain). Capsules contained creatine monohidrate (Creapure, Crown Sport Nutrition, Arnedo, Spain) | Dietary supplement | Creatine supplementation |
| PlaceboThe supplements were provided in capsules of 1 g of red color not transparent Guinama S.L.U, 0044634, La Pobla de Valbona, Spain) which were prepared with a Capsunorm 2000 semi-automatic manual capsule filling machine (Miranda del Ebro, Spain). Capsules contained placebo (i.e., sucrose) | Dietary supplement | Placebo supplementation |
Primary outcome
Pain evaluation
Time frame: 8-weeks
For assessing pain, the Victorian Institute for Sports Assessment - Patella (VISA - P), the most widely used patient-reported outcome measure (including symptom severity), was administered . The VISA - P will be scored with a maximum of 100 points and the higher scores indicate better function, and it shows sensible to identify improvements in therapeutic interventions among patients with tendinopathies.
Tendon thickness.
Time frame: 8-weeks
Thickness Tendon of the injuried knee/s was analyzed with ultrasound (GE VENUE 40, Portable Ultrasound, CA, USA), and a linear translator. Participants were positioned supine with a 30º knee flexion (using a roller under the knees), reducing the "locking" of the patella in the femur as in full extension. Ultrasound gel was applied and evaluated by placing the probe longitudinally; in pathological tendons it is the only way to determine the distance of the measurement point from the insertion of the tendon. Thus, subsequent measurements were always made from the same point.
1 secondary outcome
Neuromuscular function
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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. This study is not recruiting at the moment.
Angela Sánchez-Gómez, PhD principal investigator
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine supplementation in people with Creatine and Patellar Tendinopathy, run by Universidad Pontificia Comillas 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 7 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation (time frame: 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.