CClinicalTrials.gg
Status unknownNCT04334642MPSUpdated Feb 10, 2021

Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team

An interventional study of A mindfulness based intervention in Stress, sponsored by Centro Mente Aberta de Mindfulness. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Centro Mente Aberta de Mindfulness · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2019, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress

Keywords

  • Paralympic Games
  • Mindfulness
  • Sport
  • Athletes
  • Boccia
03

In context

Lead sponsor

Centro Mente Aberta de Mindfulness is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be an Athlete from the Paralympic Boccia Brazilian Team

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Athletes from the Paralympic Boccia Brazilian Team

    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.

    Other: A mindfulness based intervention

Interventions

  • OtherA mindfulness based intervention

    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).

    Also known as: Mindfulness Training, MBHP

06

What researchers measure

Primary outcomes

  1. Change in quality of life

    WHOQOL-bref means World Health Organization Quality of Life Assessment - bref. This Scale assesses quality of life: it is an abbreviated version of the WHOQOL-100 with 26 questions divided into four domains, namely, physical, psychological, social relations and the environment. The answers follow a Likert scale (from 1 to 5, how much the higher the score the better the quality of life).

    Time frame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)

Secondary outcomes

  1. Change of sports performance

    The Pitch Accuracy Test used by the Brazilian Boccia Team in a regular basis.

    Time frame: T0 (baseline), T4 (12 months)

  2. Change of sports performance (II)

    The Ball Speed Test used by the Brazilian Boccia Team in a regular basis.

    Time frame: T0 (baseline), T4 (12 months)

Other outcomes

  1. Change of attention focus and perceived stress

    MAAS means Mindful Attention Awareness Scale; this scale is a 15-item scale designed to assess a central characteristic of the state of mindfulness: an open or receptive awareness; higher scores reflect higher levels of dispositional mindfulness.The DASS-21 means Depression Anxiety and Stress Scale; this Scale assesses the emotional state: it is a clinical assessment lasting 3 minutes and 21 questions; It measures the three related states of depression, anxiety and stress; scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

    Time frame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)

07

Study locations

1 site
  • Centro Mente Aberta em Mindfulness
    São Paulo, 04753-060, Brazil
08

References and documents

Publications

  • Rothlin P, Birrer D, Horvath S, Grosse Holtforth M. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment. BMC Psychol. 2016 Jul 26;4(1):39. doi: 10.1186/s40359-016-0147-y. PubMed 27457721 ↗
  • Buhlmayer L, Birrer D, Rothlin P, Faude O, Donath L. Effects of Mindfulness Practice on Performance-Relevant Parameters and Performance Outcomes in Sports: A Meta-Analytical Review. Sports Med. 2017 Nov;47(11):2309-2321. doi: 10.1007/s40279-017-0752-9. PubMed 28664327 ↗
  • Kozasa EH, Sato JR, Lacerda SS, Barreiros MA, Radvany J, Russell TA, Sanches LG, Mello LE, Amaro E Jr. Meditation training increases brain efficiency in an attention task. Neuroimage. 2012 Jan 2;59(1):745-9. doi: 10.1016/j.neuroimage.2011.06.088. Epub 2011 Jul 7. PubMed 21763432 ↗
  • Jones G. More than just a game: research developments and issues in competitive anxiety in sport. Br J Psychol. 1995 Nov;86 ( Pt 4):449-78. doi: 10.1111/j.2044-8295.1995.tb02565.x. PubMed 8542197 ↗
  • Hardy L, Jones G. Current issues and future directions for performance-related research in sport psychology. J Sports Sci. 1994 Feb;12(1):61-92. doi: 10.1080/02640419408732158. PubMed 8158748 ↗
  • Burns L, Weissensteiner JR, Cohen M. Lifestyles and mindsets of Olympic, Paralympic and world champions: is an integrated approach the key to elite performance? Br J Sports Med. 2019 Jul;53(13):818-824. doi: 10.1136/bjsports-2018-099217. Epub 2018 Oct 23. PubMed 30352862 ↗
  • Navarro-Haro MV, Lopez-Del-Hoyo Y, Campos D, Linehan MM, Hoffman HG, Garcia-Palacios A, Modrego-Alarcon M, Borao L, Garcia-Campayo J. Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. PLoS One. 2017 Nov 22;12(11):e0187777. doi: 10.1371/journal.pone.0187777. eCollection 2017. PubMed 29166665 ↗
  • Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10. PubMed 18329323 ↗

Individual participant data

Plan to share: Yes — Data will be shared by research gate.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04334642
Lead sponsor
Centro Mente Aberta de Mindfulness
Responsible party
Marcelo Demarzo, MD, PhD (Head and Associate Professor, Centro Mente Aberta de Mindfulness) — Principal investigator
First posted
Apr 6, 2020
Start date
Jun 30, 2019
Primary completion
Dec 10, 2020
Completion
Apr 25, 2021 (estimated)
Last update
Feb 10, 2021

Study contacts

Marlúcia S Jesus, Student
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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