NCT04334642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

March 24, 2020

Last Update Submit

February 8, 2021

Conditions

Keywords

Paralympic GamesMindfulnessSportAthletesBoccia

Outcome Measures

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).

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

Secondary Outcomes (2)

  • Change of sports performance

    T0 (baseline), T4 (12 months)

  • Change of sports performance (II)

    T0 (baseline), T4 (12 months)

Other Outcomes (1)

  • Change of attention focus and perceived stress

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

Study Arms (1)

Athletes from the Paralympic Boccia Brazilian Team

EXPERIMENTAL

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

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
Athletes from the Paralympic Boccia Brazilian Team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Must be an Athlete from the Paralympic Boccia Brazilian Team

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Mente Aberta em Mindfulness

São Paulo, 04753-060, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 27457721BACKGROUND
  • 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.

    PMID: 28664327BACKGROUND
  • 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.

    PMID: 21763432BACKGROUND
  • 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.

    PMID: 8542197BACKGROUND
  • 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.

    PMID: 8158748BACKGROUND
  • 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.

    PMID: 30352862BACKGROUND
  • 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.

    PMID: 29166665BACKGROUND
  • 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.

    PMID: 18329323BACKGROUND

Related Links

Study Officials

  • Marlúcia S Jesus, Student

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head and Associate Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

April 6, 2020

Study Start

June 30, 2019

Primary Completion

December 10, 2020

Study Completion

April 25, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Data will be shared by research gate.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
December 2021. Will be available for 2 years
Access Criteria
Access will be granted to those researchers who are interested in developing studies with objectives similar to this research.

Locations