- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274033
Effect of Manual Lymphatic Drainage on Muscle Fatigue in Female 11-a-side Football Players (EDLMF11)
Study Overview
Detailed Description
This study aims to assess the effectiveness of manual lymphatic drainage (MLD) as a recovery strategy following induced fatigue in female football players. The intervention is applied immediately after a standardized fatigue protocol using a linear encoder to objectively measure performance decline. The study adopts a multidimensional approach, integrating biomechanical, physiological, and psychometric variables to evaluate recovery.
Participants will undergo three experimental sessions involving a fatigue protocol followed by either MLD or control conditions. Performance will be assessed through guided machine squats, measuring the number of repetitions and time until a 20% velocity loss. Thigh circumference will be measured pre- and post-intervention to monitor fluid shifts and potential edema. Subjective recovery perception will be recorded, and emotional state will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) to explore its influence on fatigue and recovery response.
This trial addresses the need for non-invasive, efficient recovery strategies tailored to female athletes, considering sex-specific physiological and psychological factors. The findings may contribute to optimizing post-exercise recovery protocols and reducing injury risk in women's football.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Edurne Úbeda D'Ocasar, Doctor
- Phone Number: 19217 +34 8153131
- Email: eubeda@ucjc.edu
Study Locations
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Madrid, Spain, 28691
- Recruiting
- University of Camilo José Cela
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Contact:
- Edurne Úbeda Docasar
- Email: eubeda@ucjc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female athletes actively participating in 11-a-side football, either federated or official team members.
- Age ≥ 16 years to 20 years old.
- Regular training (≥ 3 sessions per week) or active competition
- No food intake within 3 hours prior to evaluation (to standardize the influence of digestion on performance).
- No acute lower limb injury in the past 3 months.
- Availability to attend all three study visits.
- Signed informed consent; for participants under 18, parental consent is also required.
Exclusion Criteria:
- History of deep vein thrombosis
- Decompensated heart failure
- Active lower limb infection
- Pregnancy
- Recent lower limb surgery (< 3 months), or any medical contraindication to receiving manual lymphatic drainage (MLD).
- Failure to comply with the fasting requirement prior to performance testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Manual Lymphatic Drainage Group
The study consists of three visits.
During the first visit, participants are informed about the study, eligibility criteria are verified, informed consent is obtained, and baseline assessments are conducted using psychophysiological questionnaires and thigh circumference measurements.
In the second visit, assessments are repeated and fatigue is induced through guided squats at 50-60% of estimated 1RM, monitored via a linear encoder.
Fatigue is defined as a 20% loss in execution velocity.
Immediately after fatigue induction, manual lymphatic drainage (MLD) is applied for 10 minutes (5 minutes per quadriceps), following Emil Vodder's standardized technique.
Post-intervention, performance testing and measurements are repeated.
The third visit, conducted 15 days later, serves as a follow-up to evaluate sustained effects without further intervention, repeating the fatigue protocol and all assessments.
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This method, part of complex decongestive physiotherapy, involves gentle massage techniques that stimulate lymphatic circulation and venous return.
MLD promotes lymph fluid mobilization, increases lymphangiomotor activity, and has positive effects on the immune system.
Its application has shown to reduce limb edema, decrease muscle fatigue, and raise pain thresholds.
Moreover, the gentle touch during MLD activates cutaneous receptors that influence the parasympathetic nervous system, producing physiological changes such as reduced heart rate, blood pressure modulation, and increased muscle strength.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of repetitions
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Number of repetitions until 20% velocity loss: recorded via linear encoder during guided squat test.
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Time to fatigue
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Time to fatigue (seconds): total time from first repetition until velocity drops by 20%.
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Velocity profile
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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average velocity per repetition, expressed in m/s.
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Thigh circumference (cm)
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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measured with a non-elastic tape at the midpoint between the anterior superior iliac spine and the upper border of the patella, in both legs, pre- and post-intervention.
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Perceived fatigue
Time Frame: baseline; 5 minutes before and 5 moinutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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assessed using Borg CR-10 scale (0 = no fatigue, 10 = maximum fatigue).
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baseline; 5 minutes before and 5 moinutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Perceived pain (VAS)
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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assessed using Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (maximum pain).
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Perceived recovery (PRS)
Time Frame: baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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assessed using the Perceived Recovery Status Scale (PRS), ranging from 0 (no recovery) to 10 (full recovery).
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baseline; 5 minutes before and 5 minutes after the first procedure, 5 minutes before and 5 minutes after the second procedure, and 15 days after the procedure was completed.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality (PSQI)
Time Frame: baseline, after the second procedure and 15 days after the procedure was completed
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assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0 to 21 (higher scores indicate poorer sleep quality).
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baseline, after the second procedure and 15 days after the procedure was completed
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Emotional state
Time Frame: baseline, after the second procedure and 15 days after the procedure was completed
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assessed using the Hospital Anxiety and Depression Scale (HADS), comprising 14 items across anxiety and depression subscales (scores range from 0 to 21 per subscale).
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baseline, after the second procedure and 15 days after the procedure was completed
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Sociodemographic Variables
Time Frame: Baseline
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Age, Height, Body weight, Body mass Index
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Baseline
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Dominant leg
Time Frame: Baseline
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self-reported (leg used to kick the ball).
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Baseline
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Sports experience (years)
Time Frame: baseline
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total years of systematic football practice.
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baseline
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Training frequency (sessions/week)
Time Frame: baseline
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average number of sessions during the season.
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baseline
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Menstrual cycle phase
Time Frame: baseline, after the second procedure and 15 days after the procedure was completed
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self-reported, to control for physiological variations in fatigue and recovery.
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baseline, after the second procedure and 15 days after the procedure was completed
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edurne Úbeda Docasar, Doctor, University Camilo José Cela
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCJCDLMF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
What IPD Will Be Shared:
De-identified individual participant data (IPD) related to primary and secondary outcome measures, including performance metrics (e.g., number of repetitions, velocity profiles), anthropometric data (e.g., thigh circumference), and questionnaire responses (e.g., Borg scale, VAS, PRS, PSQI, HADS).
When Will IPD Be Available:
IPD will be made available upon publication of the main results or within 12 months after study completion.
How Will IPD Be Shared:
Data will be shared upon reasonable request to the principal investigator. Access will be granted for academic and non-commercial research purposes, following approval by the ethics committee and under a data-sharing agreement to ensure confidentiality and compliance with GDPR.
With Whom:
Qualified researchers affiliated with academic institutions or research organizations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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