Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-09-02
2019-11-30
Brief Summary
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Detailed Description
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INTERVENTION All participants will be assessed at baseline and at the end of treatment (discharge) by a blinded investigator.
The program will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work.
The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
The experimental group will develop the exercise program on the whole body vibration platform, and control group on the switched-off vibration device (without any vibration stimuli)
DESIGN AND STATISTICS
This study will be a randomized clinical trial with a control group. It will consider an alpha or type I error of 95% and a beta or type II error of 80%, with a hypothesis to a tail. The randomized controlled trial will be performed with a single-blind (the evaluator who evaluated the outcome measures remained blinded to the participants' allocation group). The sample will be randomly selected through the randomized.com program among the patients that meet the inclusion criteria that we will be described later. Participants will be distributed equally between the control group and the experimental group.
The research protocol will be carried out in accordance with the Declaration of Helsinki statement of ethics, legal and regulatory principles to provide guidance for research related to health in humans. The CONSORT guidelines have been the reference to design the Project, the ad will be used to make the final report.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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WBV group (experimental)
Participants in the experimental group will follow a program that will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work.
The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
Whole body vibration
In this study an axial vibratory platform will be used: POWER-PLATE pro 5 AIRdaptive TM HP®. This device is reviewed annually by the technical unit of the company itself and complies with the international regulations that regulate the Medical Devices \[Devices Directive (MDD) 93/42 / EEC (ISO 2631. 2011, Powerplate.com, 2013)\]. The vibration will be administered with 2 mm of amplitude and 40 Hz of frequency.
Exercise group (control)
Control subjects will perform the same exercise program without whole-body vibration.
EXERCISE group
The program will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work. The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
Interventions
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Whole body vibration
In this study an axial vibratory platform will be used: POWER-PLATE pro 5 AIRdaptive TM HP®. This device is reviewed annually by the technical unit of the company itself and complies with the international regulations that regulate the Medical Devices \[Devices Directive (MDD) 93/42 / EEC (ISO 2631. 2011, Powerplate.com, 2013)\]. The vibration will be administered with 2 mm of amplitude and 40 Hz of frequency.
EXERCISE group
The program will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work. The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
Eligibility Criteria
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Inclusion Criteria
* Participants with a self-reported pain intensity ≥ 30 mm on the Visual Analogue Scale
Exclusion Criteria
* to have received knee injections of corticosteroids or hyaluronic acid;
* cognition or impaired communication;
* to be involved in an ongoing medical-legal dispute.
40 Years
65 Years
MALE
No
Sponsors
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University of Seville
OTHER
Universidad Miguel Hernandez de Elche
OTHER
Responsible Party
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Sergio Hernandez Sanchez
Lecturer
Locations
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A360 Heath and Sport Clinic
Seville, , Spain
Countries
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References
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Yanez-Alvarez A, Bermudez-Pulgarin B, Hernandez-Sanchez S, Albornoz-Cabello M. Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial. BMC Musculoskelet Disord. 2020 Aug 28;21(1):582. doi: 10.1186/s12891-020-03599-2.
Other Identifiers
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0916
Identifier Type: -
Identifier Source: org_study_id