Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
Primary Purpose
Lower Limb Injury
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
State-Trait Anxiety Questionnaire
Rating of Perceived Exertion
Motor coordination tests
Physiotherapeutic intervention
Data Analysis
Sponsored by
About this trial
This is an interventional treatment trial for Lower Limb Injury focused on measuring Lower limbs, Physiotherapy, Athlete, Biomechanics, Protocol
Eligibility Criteria
Inclusion Criteria:
- Active athletes
- Presentation of typical clinical signs of acute fatigue in one of the two lower limbs
- Positive diagnosis of acute fatigue
Exclusion Criteria:
- Not compatible with age range
- Healthy athletes
- Diagnosed injuries other than acute fatigue
Sites / Locations
- Gema León Physiotherapy and Rehabilitation ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1: Compression technique
Group 2: Massage techniques
Group 3: Hydromassage
Group 4: Active recovery technique.
Arm Description
20 participants make up the compression technique group.
20 participants make up the massage technique group.
20 participants make up the hydromassage technique group.
20 participants make up the active recovery technique group.
Outcomes
Primary Outcome Measures
State-Trait Anxiety Questionnaire (STAI)
The range or index of anxiety perceived during the exam and the ability to tolerate anxious moments are evaluated.
Rating of Perceived Exertion (RPE)
The range or rate of perceived exertion during the scan is evaluated.
Scale Countermovement jump (CMJ)
The range or index of neuromuscular performance during the scan is evaluated.
Secondary Outcome Measures
Number of participants in each physical therapy application
Five reviews were carried out corresponding to the five months of treatment. During these five months, the 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.
Group 4 (n=20) received the active recovery treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05167162
Brief Title
Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
Official Title
Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Gema Leon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The etiology of injury in sport is multifactorial, generated by both intrinsic and extrinsic factors. There is evidence that supports that the management and handling of loads is the factor that generates the greatest risk of injury and that not respecting the load-recovery balance can lead to an accumulation of fatigue resulting in poor training adaptation which leads to increased risk of injury. From a physiological approach, fatigue is defined as a functional failure of the organism which, due to excessive energy expenditure and depletion of substrates necessary for energy production, leads to a decrease in performance.
Acute fatigue is the inability to generate a required or expected level of exercise force or intensity, whether or not preceded by previous exercise. Acute fatigue 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. Peripheral or neuromuscular fatigue is the result of altered musculoskeletal homeostasis due to a limitation or failure of one or more motor unit processes, producing a dysfunction in the contraction process. Central fatigue is an involuntary failure in brain function or nerve impulse conduction, resulting in impaired transmission from the central nervous system (CNS) and impaired motor axon recruitment. One of the main factors associated with central fatigue is the alteration of synthesis and activity of some neurotransmitters.
Elite athletes push their training to the limit in order to maximize their performance. This generates muscle damage that results in a breakdown of structural proteins of muscle fibers and connective tissues, causing tissue inflammation, Delayed Onset Muscle Soreness (DOMS) and an increase in perceived fatigue. To maximize an athlete's ability to perform, it is not only the training that must be addressed, but also the balance between training and recovery. This prevents maladaptation to physiological and psychological stresses induced by the load. Therefore, it is important for the athlete to optimize the recovery period to reduce the risk of injury.
The purpose of this research is to demonstrate the efficacy of various physiotherapeutic protocols, analyzing the degree of effectiveness in each of these for recovery from acute fatigue in athletes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Injury
Keywords
Lower limbs, Physiotherapy, Athlete, Biomechanics, Protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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)
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Compression technique
Arm Type
Active Comparator
Arm Description
20 participants make up the compression technique group.
Arm Title
Group 2: Massage techniques
Arm Type
Active Comparator
Arm Description
20 participants make up the massage technique group.
Arm Title
Group 3: Hydromassage
Arm Type
Active Comparator
Arm Description
20 participants make up the hydromassage technique group.
Arm Title
Group 4: Active recovery technique.
Arm Type
Active Comparator
Arm Description
20 participants make up the active recovery technique group.
Intervention Type
Diagnostic Test
Intervention Name(s)
State-Trait Anxiety Questionnaire
Other Intervention Name(s)
STAI
Intervention Description
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:
Not at all
Little
Sometimes
Almost always
Always
Intervention Type
Diagnostic Test
Intervention Name(s)
Rating of Perceived Exertion
Other Intervention Name(s)
RPE
Intervention Description
The scale measures in ordinal form (1 to 6) the perceived effort during the exercise as follows:
No pain
Little pain
Moderate
Severe
Very strong
Unbearable
Intervention Type
Diagnostic Test
Intervention Name(s)
Motor coordination tests
Intervention Description
The motor coordination tests are divided into three:
Jumping with 2 feet together.
Throwing 2 balls from a given distance and space.
Proprioception turns
Intervention Type
Procedure
Intervention Name(s)
Physiotherapeutic intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Data Analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Questionnaire (STAI)
Description
The range or index of anxiety perceived during the exam and the ability to tolerate anxious moments are evaluated.
Time Frame
five months
Title
Rating of Perceived Exertion (RPE)
Description
The range or rate of perceived exertion during the scan is evaluated.
Time Frame
five months
Title
Scale Countermovement jump (CMJ)
Description
The range or index of neuromuscular performance during the scan is evaluated.
Time Frame
five months
Secondary Outcome Measure Information:
Title
Number of participants in each physical therapy application
Description
Five reviews were carried out corresponding to the five months of treatment. During these five months, the 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.
Group 4 (n=20) received the active recovery treatment.
Time Frame
five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active athletes
Presentation of typical clinical signs of acute fatigue in one of the two lower limbs
Positive diagnosis of acute fatigue
Exclusion Criteria:
Not compatible with age range
Healthy athletes
Diagnosed injuries other than acute fatigue
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gema León Bravo, Physiotherap
Phone
+34 667401116
Email
glbravo@uco.es
First Name & Middle Initial & Last Name or Official Title & Degree
Gema León Bravo, Physiotherap
Phone
+34 667401116
Email
gemafisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gema León Bravo, Physiotherap
Organizational Affiliation
Gema León Physiotherapy and Rehabilitation Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Arenas Quiles, Physiotherap
Organizational Affiliation
Universidad de Córdoba
Official's Role
Study Chair
Facility Information:
Facility Name
Gema León Physiotherapy and Rehabilitation Clinic
City
Córdoba
State/Province
Andalucía
ZIP/Postal Code
14011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gema León Bravo, Physiotherap
Phone
+34 667401116
Email
gemafisio@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The request for the data will be studied and considered upon prior and justified request.
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Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
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