- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06871202
Manual Therapy and Physical-sport Performance
Influence of Manual Therapy on Physical-sport Performance
The study aims to observe the influence of manual therapy on physical and sporting performance. Manual therapy and physiotherapy have always been associated with post-exercise or as a means of recovering from injuries. The objective is to see if a physiotherapy intervention based on manual therapy causes changes in physical and sporting performance.
To do this, after a brief warm-up, a series of sports tests will be carried out, where the investigators will measure variables such as strength, range of motion, and autonomic nervous system parameters. Subsequently, a series of techniques will be applied in various anatomical regions, and finally, the sports tests will be repeated, and the results will be compared.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Cruz de Tenerife
-
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38200
- Facultad de Ciencias de la Salud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Engage in low- or moderate-intensity physical activity.
- Engage in physical activity on 3 or more days per week.
- Not have any recent injury in the area of intervention that contraindicates manual intervention.
- Be willing to collaborate in the study.
Exclusion Criteria:
- Those people who had an acute injury or one that would prevent them from carrying out physical activity had any contraindication to the application of manual techniques.
- Who were not available during the dates of the study and people.
- Who were undergoing treatment with drugs that could interfere with the tests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Manual Therapy Protocol
Protocol for manual intervention using manual techniques on musculoskeletal structures
|
The techniques were divided into three main groups: first, those carried out in cervical, thoracic and upper limbs; second, lumbar, pelvic and lower limbs; and finally, only spine.
The techniques are carried out by physiotherapists with more than 15 years of healthcare experience and trained in manual therapy with more than 10 years of experience in this field.
|
|
Other: Sham Manual Protocol
Manual sham intervention protocol through the application of manual contacts on musculoskeletal structures similar to the experimental group but without similar intention or pressure
|
The placebo protocol places the hands on the same areas as the experimental one and for the same application time but without making a manipulative intervention.
|
|
Other: Control
No manual intervention
|
Control group without treatment or manual contact
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
Measure joint mobility of the spine and upper and lower limbs through photo and video capture and subsequent evaluation with software.
Measurements are also taken with goniometry and an inclinometer (angles and/or degrees).
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
Measure the force (kilograms) of the column, lower and upper limbs through dynamometry capture, horizontal force in a treadmill, viewing the force in the Russian belt and jump test.
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
|
Speed
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
Measure the speed (metres/second) of the column, lower and upper limbs through jump, encoder, and race tests.
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
|
Heart Rate Variability (HRV) as a biomarker of Stress
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
These parameters were evaluated before, during, and after the manual protocols were applied. For this purpose, the Elite HRV smartphone application was used, which connects to a Polar transmitter band placed on the person's chest at the level of the xiphoid process of the sternum, which allowed constant monitoring of the subject during each of the interventions.
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
|
Heart Rate Variability (HRV) as a biomarker of Stress
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
These parameters were evaluated before, during, and after the manual protocols were applied. For this purpose, the Elite HRV smartphone application was used, which connects to a Polar transmitter band placed on the person's chest at the level of the xiphoid process of the sternum, which allowed constant monitoring of the subject during each of the interventions.
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
|
Stress Salivary Test
Time Frame: Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
The Saliva Stress Test is a non-invasive diagnostic test that measures the levels of key stress biomarkers in the body's response. This analysis uses saliva samples collected at different times of the day (or night) to assess the rhythm of these biomarkers and their fluctuation. The saliva samples will be analysed for cortisol and IgA concentration using Ipro LFDs on a standard reader. After sample collection and mixing (2 minutes), two drops of saliva/buffer mix from the OFC will be added to the sample window of the cortisol or IgA LFFD.
|
Baseline; previous the first manual intervention and inmediatly posterior the first manual intervention (first day); 3, 7 and 14 days after the first manual intervention
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUC_2024_36
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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