Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy

NCT06482619 | Completed

• 1 other identifier: UPComillas
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 and extracorporeal shock wave therapy.

Conditions

Creatine; Patellar Tendinopathy

Keywords

Ergogenic aid; Dietary; Injury; Nutrition; Sport Nutrition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8-weeks

Secondary Outcomes (1)

• Neuromuscular function

  8-weeks

Study Arms (2)

Creatine supplementation

EXPERIMENTAL

Creatine monohydrate (Creapure®, Crown Sport Nutrition, Arnedo, Spain) ingested 3 capsules daily (3 g/day)

Dietary Supplement: Creatine supplementation

Placebo supplementation

PLACEBO COMPARATOR

Sucrose ingested 3 capsules daily (3 g/day)

Dietary Supplement: Placebo

Interventions

Creatine supplementation DIETARY_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)

Creatine supplementation

Placebo DIETARY_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)

Placebo supplementation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead
• Universidad de Córdoba: collaborator
• University of Bologna: collaborator
• Technical University of Madrid: collaborator
• Lavras University: collaborator

Study Sites (1)

Universidad Pontificia Comillas

Madrid, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Angela Sánchez-Gómez, PhD

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher who did not have any contact with the participants and the physiotherapist who performed the physical rehabilitation intervention and the assessments randomly divided the participants to the creatine or placebo groups in a computerized random list with a 1:1 allocation using the software Research Randomizer (www.randomizer.org).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2021
• Primary Completion: August 30, 2023
• Study Completion: November 1, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)