Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy (CREATINE_TEN)

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.

Study Overview

• Status: Completed
• Conditions: Creatine; Patellar Tendinopathy
• Intervention / Treatment: Dietary supplement: Creatine supplementation; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Universidad Pontificia Comillas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine supplementation; Creatine monohydrate (Creapure®, Crown Sport Nutrition, Arnedo, Spain) ingested 3 capsules daily (3 g/day)	Dietary supplement: Creatine supplementation; 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)
Placebo Comparator: Placebo supplementation; Sucrose ingested 3 capsules daily (3 g/day)	Dietary supplement: Placebo; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8-weeks

Collaborators and Investigators

• Sponsor: Universidad Pontificia Comillas
• Collaborators: University of Bologna; Universidad de Córdoba; Technical University of Madrid; Lavras University
• Investigators: Principal Investigator: Angela Sánchez-Gómez, PhD, Universidad de Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; Injury; Ergogenic aid; Dietary; Sport Nutrition
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: UPComillas

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