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StressMPSNCT04334642

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

A study testing A mindfulness based intervention in people with Stress, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress
What is being tested?
A mindfulness based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteBrazil
Study dates
30 Jun 2019to 25 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be an Athlete from the Paralympic Boccia Brazilian Team

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Centro Mente Aberta em Mindfulness

    São Paulo, 04753-060

Other trials in Brazil

About this study

Official title: Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team (MPS)

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.

Conditions
Stress
Being tested
A mindfulness based intervention
Keywords
Paralympic Games, Mindfulness, Sport, Athletes, Boccia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A mindfulness based interventionOther

    Also called Mindfulness Training, MBHP

    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).

Study groups in NCT04334642
Study groupRoleWhat they receive
Athletes from the Paralympic Boccia Brazilian TeamExperimentalThe 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.
Receives: Other: A mindfulness based intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)
  1. Change of sports performance

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

    Measured: 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.

    Measured: T0 (baseline), T4 (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start30 Jun 2019
  3. Primary completion10 Dec 2020
  4. Study completion25 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334642
Sponsor's protocol ID
19577519.2.0000.5505
Acronym
MPS
Status last verified
Feb 2021
First submitted
24 Mar 2020
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared by research gate.

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

Questions about this trial

What is this clinical trial studying?

A study testing A mindfulness based intervention in people with Stress, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life (time frame: T0 (baseline), T1 (1 week), T2 (1 month), T3 (6 months), T4 (12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334642, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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