Clinical trial NCT04334642: Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team
Official title: Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team (MPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: Paralympic Games
Mindfulness
Sport
Athletes
Boccia
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The approach of the Tokyo 2020 Paralympic Games brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of Paralympic Boccia Brazilian Team. Mindfulness means being aware and describes a natural human capacity that can be trained and previous researches indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context. Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study). The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes.

Detailed description: Since the participation of an athlete with a disability in the Olympic Games in 1904, a long road has been traveled until the Paralympic sport was understood as a standard of high performance, in which Brazil stands out when occupying the eighth place in the overall ranking of medals in the Rio 2016 Games, as well as consecutive leader in the Pan American Games (2007, 2011, 2015 and 2019). The approach of the Tokyo 2020 Paralympics brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of these athletes.

Mindfulness means being aware and describes a natural human capacity that can be trained. The option of the Paralympic Boccia Brazilian Team for a research on mindfulness is because of the identification of previous researches that indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context.

Considering that sports performance is composed of several pillars, such as physical, technical, tactical and psychological, there is an opportunity to investigate the following findings of mindfulness-based interventions in a complex population:

Mindfulness practice consistently and significantly improves levels of mindfulness across various sports disciplines.

Physiological and psychological performance improved significantly until the practice of mindfulness.

Based on the available evidence, the practice of mindfulness can be considered as a supplementary training approach to improve performance in precision sports disciplines.

Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention (MBI) on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is an exploratory study (pilot) to verify if the intervention will be well accepted by the participants (feasibility) and if it will be effective to reproduce the expected effects (preliminary effectiveness) composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study).

The research will have as a convenience sample 11 Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. This study includes the category called "Other participants" formed by staff, freshmen, technicians and other professionals who are present during the interventions. In this way, the participants totalize 25 people: there are eleven athletes categorized as "Athletes" and 14 professionals in the "Other Participants" category. The measure instruments used in the Athletes category will be the same in the Other participants category, with the exception of Performance Evaluation applied only to Athletes.

The methodological procedures of the present work were prepared within the fundamental ethical and scientific procedures, as provided for in Resolution No. 466 of December 12, 2012 of the National Health Council of Ministry of Health, being approved by the Research Ethics Committee (CEP), by protocol 19577519.2.0000.5505.

The intervention will take place at the Brazilian Paralympic Training Center - CTPB, in the City of São Paulo, SP, where an certified instructor with extensive experience in leading groups by Centro Mente Aberta - UNIFESP will conduct the MBI and recommend to athletes to incorporate formal and informal care practices into their daily lives.

It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes. In this sense, it produces practical scientific knowledge that can pave the way for the subsequent realization of a large-scale trial that will benefit the greatest number of people.

The investigation is limited by the lack of additional comparison groups and the small sample size to detect effects. However, this is justified by being Paralympic medalists who have a series of unique characteristics, according to the functional classification that includes people with severe or severe motor disabilities, caused basically by cerebral palsy, cervical spinal cord injuries and muscular dystrophies.

The relevance of this research is in its pioneering spirit and originality when evaluating the first intervention based on mindfulness with Paralympic athletes held in Brazil.

Eligibility criteria: Inclusion Criteria:

- Must be an Athlete from the Paralympic Boccia Brazilian Team

Exclusion Criteria:

* Diagnosis of an active mental disorder, such as depression and anxiety, in the initial phase of treatment
* Diagnosis of an active mental disorder, such as depression and anxiety, with severe symptoms
* Having previous experience with mindfulness (regular practice in the last 6 months)
* Athletes without access to the internet or electronic means to access audio practices

Primary outcomes:
measure: Change in quality of life
timeFrame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)
Secondary outcomes:
measure: Change of sports performance
timeFrame: T0 (baseline), T4 (12 months)
measure: Change of sports performance (II)
timeFrame: T0 (baseline), T4 (12 months)
Other outcomes:
measure: Change of attention focus and perceived stress
timeFrame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta em Mindfulness
Study officials:
affiliation: Federal University of São Paulo
name: Marlúcia S Jesus, Student
role: PRINCIPAL_INVESTIGATOR
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