NCT07354633

Brief Summary

This study is part of the desire to develop disabled sports in the territory of Seine-Saint-Denis and responds to the national strategy plan Sport Santé, 2019-2024, which addresses all audiences. The law of January 26, 2016 recognizes sport as a non-drug therapeutic in its own right, becoming an element of the hospital care pathway but also ambulatory. The partnership between the EPS of Ville-Evrard and the departmental committee of Voile du 93, co-funder of the project thus allows the diversification and the increase of the offer of care in psychosocial rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress24%
Sep 2025Dec 2028

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

November 28, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

Sailingpsychiatric disorderphysical conditions

Outcome Measures

Primary Outcomes (9)

  • scale of quality of life

    The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.

    T0: before sailing starts

  • Scale of quality of life

    The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.

    T1: within 10 minutes after the end of sailing

  • Scale of quality of life

    The questionnaire is a validated health-related quality of life scale. The scale is also recommended by the HAS to evaluate clinical practices. It is composed of 36 elements, including eight scales focusing on health: general physical state, limitations of roles related to physical health, body pain, general perception of health, vitality, social functioning, limitations of roles related to mental health. The scale can be auto or hetero administered and requires 5 to 10 minutes of handover.

    T2: Three months After Sailing

  • Warwick Edinburgh mental well being scale

    The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.

    T0: Before sailing starts

  • Warwick Edinburgh mental well being scale

    The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.

    T1: within 10 minutes after the end of sailing

  • Warwick Edinburgh mental well being scale

    The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated tool designed to measure mental wellbeing in individuals and populations, consisting of 14 positively worded items scored on a 5-point Likert scale.All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 (Never) to 5 (All the time) Likert scale. The minimum scale score is 14 and the maximum is 70. Higher scores indicate better mental well being.

    T2: Three months After Sailing

  • Self-Esteem Scale

    Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.

    T0: before sailing starts

  • Self-Esteem Scale

    Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.

    T1: within 10 minutes after the end of sailing

  • Self-Esteem Scale

    Rosenberg's Self-esteem Scale By Nathalie Crépin and Florence Delerue Self-esteem is defined as the judgment or evaluation one makes of oneself, of one's value personal. In a simpler way, self-esteem can also be assimilated to self-affirmation. Esteem of oneself is an essential factor in sports performance.This scale represents a French cross-cultural validation of the Rosenberg Self-Esteem Scale (1965). It contains 10 items, five positive and five negative assessed on a 1 to 4-point scale It takes only 8 minutes to do the scale.

    T2: Three months After Sailing

Study Arms (2)

sailing arm

ACTIVE COMPARATOR

20 users followed in the psychosocial rehabilitation unit (UNIRRE 93) and practicing the sailing activity by session of 10 sailing sessions over two periods (March to June and August to November) Twice a year (month)

Behavioral: sailing

control

PLACEBO COMPARATOR

20 control subjects: users followed in the psychosocial rehabilitation unit (UNIRRE 93) and taken care of in psychosocial rehabilitation without a veil over the same period as a "veil" session.

Behavioral: taking care in rehabilitation psychosocial

Interventions

sailingBEHAVIORAL

Users followed in the psychosocial rehabilitation unit (UNIRRE 93) and practicing the sailing activity by session of 10 sailing sessions over two periods (March to June and August to November) Twice a year (month)

sailing arm

control subjects: users followed in the psychosocial rehabilitation unit (UNIRRE 93) and taken care of in psychosocial rehabilitation without a veil over the same period as a "veil" session.

control

Eligibility Criteria

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

You may qualify if:

  • Obtaining free and informed consent to the research project
  • User over 18 years old and living in the 93
  • Living with a psychic or neurodevelopmental disorder
  • Supported by the RPS 93 platform
  • Have obtained a medical certificate of fitness for sailing including competition (only for the sailing group)
  • Knowing French language ( how to read and write)
  • Clinical condition stabilized for less than three months despite taking medication

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Psychiatric decompensation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rusheenthira Thavaseelan

Neuilly-sur-Marne, 93330, France

RECRUITING

EPS VIlle Evrard - UNIRRE 93

Neuilly-sur-Marne, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Rusheenthira thavaseelan, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: one group is voile and the other one is control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS, psychiatrist and investigator

Study Record Dates

First Submitted

November 28, 2025

First Posted

January 21, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations