NCT05167162

Brief Summary

Acute fatigue is the inability to generate a required or expected level of force or exercise intensity, whether or not preceded by previous exercise. It is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. This type of fatigue can affect both the peripheral level, generating neuromuscular or peripheral fatigue, and the central level, generating central fatigue Objective: To study several physiotherapeutic protocols, analyzing the degree of effectiveness of each one for the recovery of acute fatigue in athletes. Design: Prospective randomized experimental study with 4 groups of physiotherapeutic protocols suitable in acute fatigue recovery. Participants: Presentation of 80 patients treated with 4 therapeutic protocols, equally divided and purposely sexed. The four protocols were divided into: Active recovery (n=20) hydrotherapy (n=20) massage (n=20) and compression (n=20) for 4 weeks of treatment. Intervention: Active recovery protocols (group 1) hydrotherapy protocol (group 2) massage protocol (group 3) and comprehension protocol (group 4). Keywords: Lower limbs, physiotherapy, athlete, biomechanics, protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

November 6, 2021

Last Update Submit

August 9, 2024

Conditions

Keywords

Lower limbsPhysiotherapyAthleteBiomechanicsProtocol

Outcome Measures

Primary Outcomes (3)

  • State-Trait Anxiety Questionnaire (STAI)

    The range or index of anxiety perceived during the exam and the ability to tolerate anxious moments are evaluated.

    five months

  • Rating of Perceived Exertion (RPE)

    The range or rate of perceived exertion during the scan is evaluated.

    five months

  • Scale Countermovement jump (CMJ)

    The range or index of neuromuscular performance during the scan is evaluated.

    five months

Secondary Outcomes (1)

  • Number of participants in each physical therapy application

    five months

Study Arms (4)

Group 1: Compression technique

ACTIVE COMPARATOR

20 participants make up the compression technique group.

Diagnostic Test: State-Trait Anxiety QuestionnaireDiagnostic Test: Rating of Perceived ExertionDiagnostic Test: Motor coordination testsProcedure: Physiotherapeutic interventionOther: Data Analysis

Group 2: Massage techniques

ACTIVE COMPARATOR

20 participants make up the massage technique group.

Diagnostic Test: State-Trait Anxiety QuestionnaireDiagnostic Test: Rating of Perceived ExertionDiagnostic Test: Motor coordination testsProcedure: Physiotherapeutic interventionOther: Data Analysis

Group 3: Hydromassage

ACTIVE COMPARATOR

20 participants make up the hydromassage technique group.

Diagnostic Test: State-Trait Anxiety QuestionnaireDiagnostic Test: Rating of Perceived ExertionDiagnostic Test: Motor coordination testsProcedure: Physiotherapeutic interventionOther: Data Analysis

Group 4: Active recovery technique.

ACTIVE COMPARATOR

20 participants make up the active recovery technique group.

Diagnostic Test: State-Trait Anxiety QuestionnaireDiagnostic Test: Rating of Perceived ExertionDiagnostic Test: Motor coordination testsProcedure: Physiotherapeutic interventionOther: Data Analysis

Interventions

The scale measures ordinally (1 to 5) the values observed during exposure to anxiety patterns during exercise, such as higher repetitions, greater weight gain or longer exercise duration, as follows: 1. Not at all 2. Little 3. Sometimes 4. Almost always 5. Always

Also known as: STAI
Group 1: Compression techniqueGroup 2: Massage techniquesGroup 3: HydromassageGroup 4: Active recovery technique.

The scale measures in ordinal form (1 to 6) the perceived effort during the exercise as follows: 1. No pain 2. Little pain 3. Moderate 4. Severe 5. Very strong 6. Unbearable

Also known as: RPE
Group 1: Compression techniqueGroup 2: Massage techniquesGroup 3: HydromassageGroup 4: Active recovery technique.

The motor coordination tests are divided into three: 1. Jumping with 2 feet together. 2. Throwing 2 balls from a given distance and space. 3. Proprioception turns

Group 1: Compression techniqueGroup 2: Massage techniquesGroup 3: HydromassageGroup 4: Active recovery technique.

Participants received one session per week, until a total of 20 sessions were completed: Group 1 (n=20) received the muscle compression treatment. Group 2 (n=20) received the manual massage treatment. Group 3 (n=20) received the hydrotherapy treatment and group 4 (n=20) received the active recovery treatment.

Group 1: Compression techniqueGroup 2: Massage techniquesGroup 3: HydromassageGroup 4: Active recovery technique.

The usual descriptive parameters (mean and standard deviation) of the sample were calculated. The distribution and analysis of the other data were performed by means of a nonparametric test (Mann-Whitney U test) comparing the groups. A confidence level of 95% was established, considering a value of p\<0.05 as statistically significant.

Group 1: Compression techniqueGroup 2: Massage techniquesGroup 3: HydromassageGroup 4: Active recovery technique.

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active athletes
  • Presentation of typical clinical signs of acute fatigue in one of the two lower limbs
  • Positive diagnosis of acute fatigue

You may not qualify if:

  • Not compatible with age range
  • Healthy athletes
  • Diagnosed injuries other than acute fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

Related Publications (16)

  • Benjaminse A, Webster KE, Kimp A, Meijer M, Gokeler A. Revised Approach to the Role of Fatigue in Anterior Cruciate Ligament Injury Prevention: A Systematic Review with Meta-Analyses. Sports Med. 2019 Apr;49(4):565-586. doi: 10.1007/s40279-019-01052-6.

    PMID: 30659497BACKGROUND
  • Guan Y, Bredin S, Jiang Q, Taunton J, Li Y, Wu N, Wu L, Warburton D. The effect of fatigue on asymmetry between lower limbs in functional performances in elite child taekwondo athletes. J Orthop Surg Res. 2021 Jan 9;16(1):33. doi: 10.1186/s13018-020-02175-7.

    PMID: 33422109BACKGROUND
  • Burton I. Autoregulation in Resistance Training for Lower Limb Tendinopathy: A Potential Method for Addressing Individual Factors, Intervention Issues, and Inadequate Outcomes. Front Physiol. 2021 Aug 5;12:704306. doi: 10.3389/fphys.2021.704306. eCollection 2021.

    PMID: 34421641BACKGROUND
  • Trojian T, Driban J, Nuti R, Distefano L, Root H, Nistler C, LaBella C. Osteoarthritis action alliance consensus opinion - best practice features of anterior cruciate ligament and lower limb injury prevention programs. World J Orthop. 2017 Sep 18;8(9):726-734. doi: 10.5312/wjo.v8.i9.726. eCollection 2017 Sep 18.

    PMID: 28979857BACKGROUND
  • Franke TPC, Backx FJG, Huisstede BMA. Lower extremity compression garments use by athletes: why, how often, and perceived benefit. BMC Sports Sci Med Rehabil. 2021 Mar 24;13(1):31. doi: 10.1186/s13102-020-00230-8.

    PMID: 33761989BACKGROUND
  • Ghram A, Young JD, Soori R, Behm DG. Unilateral Knee and Ankle Joint Fatigue Induce Similar Impairment to Bipedal Balance in Judo Athletes. J Hum Kinet. 2019 Mar 27;66:7-18. doi: 10.2478/hukin-2018-0063. eCollection 2019 Mar.

    PMID: 30988836BACKGROUND
  • Cejudo A, Sainz de Baranda P, Ayala F, De Ste Croix M, Santonja-Medina F. Assessment of the Range of Movement of the Lower Limb in Sport: Advantages of the ROM-SPORT I Battery. Int J Environ Res Public Health. 2020 Oct 19;17(20):7606. doi: 10.3390/ijerph17207606.

    PMID: 33086605BACKGROUND
  • DeLang MD, Salamh PA, Farooq A, Tabben M, Whiteley R, van Dyk N, Chamari K. The dominant leg is more likely to get injured in soccer players: systematic review and meta-analysis. Biol Sport. 2021 Sep;38(3):397-435. doi: 10.5114/biolsport.2021.100265. Epub 2020 Oct 28.

    PMID: 34475623BACKGROUND
  • Gilbert FC, Burdette GT, Joyner AB, Llewellyn TA, Buckley TA. Association Between Concussion and Lower Extremity Injuries in Collegiate Athletes. Sports Health. 2016 Nov/Dec;8(6):561-567. doi: 10.1177/1941738116666509. Epub 2016 Sep 20.

    PMID: 27587598BACKGROUND
  • Drury B, Ratel S, Clark CCT, Fernandes JFT, Moran J, Behm DG. Eccentric Resistance Training in Youth: Perspectives for Long-Term Athletic Development. J Funct Morphol Kinesiol. 2019 Nov 28;4(4):70. doi: 10.3390/jfmk4040070.

    PMID: 33467385BACKGROUND
  • Mang CS, Whitten TA, Cosh MS, Dukelow SP, Benson BW. Assessment of Postural Stability During an Upper Extremity Rapid, Bimanual Motor Task After Sport-Related Concussion. J Athl Train. 2020 Nov 1;55(11):1160-1173. doi: 10.4085/1062-6050-378-19.

    PMID: 33064821BACKGROUND
  • Avedesian JM, Covassin T, Dufek JS. The Influence of Sport-Related Concussion on Lower Extremity Injury Risk: A Review of Current Return-to-Play Practices and Clinical Implications. Int J Exerc Sci. 2020 Aug 1;13(3):873-889. doi: 10.70252/WVYL1782. eCollection 2020.

    PMID: 32922630BACKGROUND
  • Frutuoso AS, Diefenthaeler F, Vaz MA, Freitas Cde L. LOWER LIMB ASYMMETRIES IN RHYTHMIC GYMNASTICS ATHLETES. Int J Sports Phys Ther. 2016 Feb;11(1):34-43.

    PMID: 26900498BACKGROUND
  • Siupsinskas L, Garbenyte-Apolinskiene T, Salatkaite S, Gudas R, Trumpickas V. Association of pre-season musculoskeletal screening and functional testing with sports injuries in elite female basketball players. Sci Rep. 2019 Jun 26;9(1):9286. doi: 10.1038/s41598-019-45773-0.

    PMID: 31243317BACKGROUND
  • Dubose DF, Herman DC, Jones DL, Tillman SM, Clugston JR, Pass A, Hernandez JA, Vasilopoulos T, Horodyski M, Chmielewski TL. Lower Extremity Stiffness Changes after Concussion in Collegiate Football Players. Med Sci Sports Exerc. 2017 Jan;49(1):167-172. doi: 10.1249/MSS.0000000000001067.

    PMID: 27501359BACKGROUND
  • Beck B, Drysdale L. Risk Factors, Diagnosis and Management of Bone Stress Injuries in Adolescent Athletes: A Narrative Review. Sports (Basel). 2021 Apr 16;9(4):52. doi: 10.3390/sports9040052.

    PMID: 33923520BACKGROUND

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Gema León Bravo, Physiotherap

    Gema León Physiotherapy and Rehabilitation Clinic

    PRINCIPAL INVESTIGATOR
  • Rafael Arenas Quiles, Physiotherap

    Universidad de Córdoba

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 80 patients divided into 4 groups of equal size and randomly selected. The 4 treatment methods used will be as follows: Group 1: Compression techniques (n=20). Group 2: Massage techniques (n=20) Group 3: Hydrotherapy (n=20) Group 4: Active recovery technique (n=20)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 22, 2021

Study Start

November 6, 2021

Primary Completion

April 21, 2022

Study Completion

April 30, 2022

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The request for the data will be studied and considered upon prior and justified request.

Locations