Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Influence of Tennis in Early Intervention (ITIP)

5. juni 2026 opdateret af: Dr Mirvat HAMDAN-DUMONT, Centre Hospitalier Esquirol

The Influence of Tennis in Early Intervention (ITIP): a Pilot Study

This study involves two groups of participants: one participating in an intervention focused on self-esteem-and thus primarily psychological-and the other on self-esteem and tennis-and thus involving physical activity. The objectives of this study are to document participants' experiences following their participation in the group offered to them, as well as to quantify any changes in the various areas detailed below. In this study, we aim to identify the benefits gained following a group intervention in the social, academic/professional, clinical, and physical domains; we also seek to objectively assess any changes in cognition, self-esteem, perceived physical value, quality of life, social functioning, negative symptoms, and self-stigmatization.

Studieoversigt

Detaljeret beskrivelse

  1. Background Physical activity can be defined as any movement or contraction produced by skeletal muscles that results in an increase in energy expenditure beyond that at rest. In the general population, low levels of physical activity are considered one of the leading causes of mortality, constituting a risk factor for cardiovascular disease. The findings are similar among individuals with psychiatric disorders.

    Various studies have indeed examined the effects of physical activity in schizophrenia. Some authors therefore highlight the benefits regarding physical fitness, the severity of both negative and positive symptoms, anxiety-depressive symptoms, as well as cognitive, social, and cardiovascular functioning and quality of life.

    As a result, intervention programs for schizophrenia that incorporate sports activities have been developed, such as RemedRugby, which consists not only of playing Touch Rugby but also of psychoeducation, cognitive and social remediation, and social skills training-a program that has demonstrated benefits in terms of cognitive and social functioning, quality of life, and self-stigmatization. Since the goal of intervention is to intervene as early as possible to limit the transition to psychosis, other authors have examined sports participation among patients at risk for psychosis. Koivukangas et al. found that adolescents who later developed psychosis were three to four times less physically active, with an inverse correlation between the number of prodromal symptoms and physical activity. This inactivity is in fact associated with dysfunction in the frontal lobes, with the hippocampal impairment mentioned earlier already present in the prodromal phase of the illness. Furthermore, Chalfoun et al. note that young patients with early-onset psychosis are at higher risk of weight gain upon initiation of antipsychotic treatment, providing further support for interventions based on physical activity.

    When asked, young people classified as Ultra High Risk (UHR) linked their physical inactivity to low motivation and the presence of anxiety and depressive symptoms, which further reinforced their social withdrawal. However, a desire to improve their physical health emerged from this study by Carney et al. by offering them activities tailored to their challenges, which could, among other things, improve their self-esteem. Dean et al. also demonstrated that three months of sports participation enabled UHR youth to improve not only their symptom expression but also their cognitive and social functioning. Similarly, physical activity appears to be a resource for individuals who have experienced a First Psychotic Episode (FPE), as it can help limit weight gain associated with antipsychotics, as previously noted by Chalfoun et al. It may also help reduce psychotic symptoms and provide an outlet, improve cognitive functioning, promote social interactions, and foster a sense of purpose and control.

    Given the research investigating the benefits of physical activity in individuals with schizophrenia and the growing interest in emerging pathologies among young adults, the present study hypothesizes that group tennis practice will have benefits on the symptomatology, cognition, and functioning of UHR/PEP individuals.

  2. Participants INCLUSION CRITERIA Patients aged 18 to 30 years receiving care at the e-DIP and presenting with UHR/PEP EXCLUSION CRITERIA

    • Motor disability
    • intellectual disability,
    • depression,
    • insufficient French language proficiency,
    • subject's refusal,
    • currently undergoing cognitive remediation

EXCLUSION CRITERIA Physical injury, psychological decompensation, inpatient hospitalization Absence from a tennis or self-esteem group session does not constitute a criterion for exclusion. Regarding tennis, participation in at least 6 sessions is required for the data to be analyzable. Regarding self-esteem, any missed session will be made up in an individual format.

3 Procedures

: This is an open-label prospective study consisting of two unmatched parallel groups. Each group will consist of 4 experimental subjects and 4 control subjects.

Participants will undergo a pre-inclusion visit, during which the research project will be presented; then, during the inclusion visit (M0), informed consent, various sociodemographic data, medication information, and results from neuropsychological tests and scales will be collected. These include (estimated total duration 60-80 minutes):

  • Rosenberg Self-Esteem Scale, commonly used in practice due to its short administration time (estimated 1-2 minutes) and psychometric properties; it consists of 10 statements regarding self-perception to be rated on a 4-point Likert scale ("strongly disagree," "somewhat disagree," "somewhat agree," "strongly agree") (Rosenberg, 1965; Vallieres & Vallerand, 1990)
  • 25-item Physical Self-Concept Inventory (ISP-25), assessing 5 dimensions, namely general self-esteem, perceived physical worth, physical fitness, athletic ability, physical appearance, and perceived strength using a 6-point Likert scale (ranging from "not at all" to "completely"); estimated duration 2-3 minutes (Ninot et al., 2000).
  • Quality of Life Scale (WHOQOL-Bref), developed by the World Health Organization to assess general quality of life across four domains: physical health, social well-being, social relationships, and environment; rated on a 5-point Likert scale (ranging from "very poor" to "very good," "very dissatisfied/not at all satisfied" to "very satisfied," "not at all" to "extremely/completely/very much," or "never" to "always" depending on the item); estimated completion time of 2-3 minutes.
  • Social Functioning Scale (QFS), developed for patients in psychiatric care and assessing, over the past 2 weeks, both the frequency of social behaviors and satisfaction with them, and demonstrating sensitivity to change; rated on a 5-point Likert scale (ranging from "every day" to "never" and from "very satisfied" to "very dissatisfied"); estimated time: 2-3 minutes.
  • Negative Symptom Scale (SNS), validated in French, which uses a 3-point Likert scale ("strongly agree," "somewhat agree," "strongly disagree") 20 items covering social withdrawal, diminished emotional experience, alogia, avolition, and anhedonia; estimated duration 1-2 minutes.
  • Self-Stigma Scale (ISMI) assessing, on a 4-point Likert scale (ranging from "strongly agree" to "strongly disagree"), 29 items leading to a total self-stigma score in individuals with a mental health disorder (estimated time: 2-3 minutes). Six subscores can be calculated, distinguishing between alienation, endorsement of stereotypes, experiences of discrimination, social withdrawal, and resistance to stigma.
  • Commonly used neuropsychological tests with demonstrated psychometric qualities.
  • RL/RI-16, assessing verbal memory through the learning of a list of 16 words in short-term memory and after a 20-minute delay (estimated duration 20-30 minutes); scoring of words recalled in immediate recall, 3 free recalls, and 3 total recalls according to established norms
  • d2-R: assessment of attention via a 5-minute interference task; scoring of concentration ability, processing speed, and accuracy percentage according to established norms
  • WAIS-IV Digit Span, assessing working memory via a span task in direct, indirect, and reverse orders, lasting 5 to 10 minutes; scoring of the total number of correct items according to established norms
  • TMT A and B, assessing reactive flexibility via a dot-connecting task with alternating instructions, duration 2 to 3 minutes; scoring of time and errors according to established norms
  • WAIS-IV codes, assessing processing speed via a graphomotor execution task, duration 2 minutes; scoring of the number of correct responses according to established norms
  • Stroop, assessing inhibition via the "interference" sheet following the "naming" and "reading" control sheets, duration of 5 minutes; scoring of time and errors according to established norms

Participants will take part in 8 one-hour tennis sessions led by a certified instructor (the number of sessions will be determined in consultation with the instructor, taking into account the patients' specific needs), which will proceed as follows:

  • Approximately 5-minute welcome period for participants
  • Approximately 5-minute warm-up around the court
  • Practice time: getting comfortable with the racket and first rallies in Session 1, adding forehand/backhand alternating drills in Session 2, adding serves and 1-on-1 rallies on half-court in Session 3, repeating the drills and increasing the complexity of the instructions for the remaining sessions
  • Putting away equipment and restoring the clay court and/or a self-esteem group inspired by Tania Lecomte's "I'm Awesome!" module, consisting of 9 sessions of 1 hour and 30 minutes each, structured as follows:
  • Watching a video introducing the concept of self-esteem (YouTube channel "Et tout le monde s'en fout")
  • Work on the sense of security in sessions 1 and 2
  • Working on a sense of identity in sessions 3 and 4
  • Working on a sense of belonging in sessions 4 and 5
  • Working on a sense of direction in sessions 6 and 7
  • Working on a sense of competence in sessions 8
  • Group conclusion and "Self-Esteem in 3D" dice game Finally, participants will undergo the same neuropsychological and psychometric assessment described earlier at the end of the study (M3).

    4 Objectives Primary Objective To compare the subjective experiences in the social, academic/professional, clinical, and physical domains between a group participating in tennis combined with a self-esteem program and a group participating only in a self-esteem program Secondary Objectives

To compare a group participating in tennis combined with a self-esteem program with a group participating only in a self-esteem program:

  • cognitive performance,
  • overall self-esteem
  • perceived physical value
  • quality of life,
  • social functioning,
  • negative symptoms
  • self-stigmatization

Evaluation criteria Primary outcome measure

  • 10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?")

Secondary outcome measures

  • Neuropsychological tests assessing: verbal memory (RL/RI-16), attention (d2-R), working memory (WAIS-IV Digit Span), flexibility (TMT A and B), processing speed (WAIS-IV Coding), and inhibition (Stroop Interference Task)
  • Self-Esteem Scale (Rosenberg Scale),
  • Physical Self-Concept Inventory (ISP-25)
  • Quality of Life Scale (WHOQOL-Bref scale),
  • Social Functioning Scale (QFS)
  • Negative Symptom Scale (SNS),
  • Self-Stigma Index (ISMI)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Limoges, Frankrig, 87025
        • Centre Hospitalier Esquirol

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Patients aged 18 to 30 years diagnosed with at-risk mental state or first episode psychosis

Exclusion Criteria:

  • Motor disability
  • intellectual disability,
  • depression,
  • insufficient French language proficiency,
  • subject's refusal,
  • currently undergoing cognitive remediation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Tennis + Self esteem program
Participants in Group 1 took part in 8 tennis sessions and 6 self-esteem sessions.
Eight tennis sessions, each lasting 1 hour and 15 minutes, led by a sports instructor specializing in tennis and a nurse case manager. The sessions took place at a tennis club.
The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings. 6 sessions.
Aktiv komparator: Group 2: self-esteem program
Participants in Group 2 only took part in 6 self-esteem sessions.
The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings. 6 sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale
Tidsramme: 2 minutes
10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?"). A higher score means a better outcome.
2 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rappel Libre / Rappel Indicé - 16 (RL/RI-16).
Tidsramme: 15 minutes

A neuropsychological memory test that assesses verbal episodic memory through free recall and cued recall of 16 words.

Minimum score 0, maximum Score 48. A higher score means a better outcome.

15 minutes
d2-R
Tidsramme: 5 minutes

A neuropsychological attention test that measures selective attention, concentration, and processing speed through a visual cancellation task.

d2-R: The d2-R does not have a single fixed minimum or maximum score because it yields several indices, including the total number of processed items, omission and commission errors, concentration performance, and error percentage. While some indices have a minimum score of 0, their maximum values depend on the number of items completed during the task. Therefore, performance is typically interpreted using age-adjusted normative scores, such as percentiles or standard scores, rather than fixed raw score ranges.

A better score means a better outcome.

5 minutes
WAIS-IV Digit Span
Tidsramme: 5 to 10 minutes

A neuropsychological subtest that assesses attention, working memory, and mental manipulation by requiring the repetition of number sequences.

Minimum score 0, maximum score 48.

5 to 10 minutes
Trail Marking Tests TMT A and B
Tidsramme: 2 minutes

TMT-A: A neuropsychological test that measures visual scanning, attention, and processing speed by connecting numbered items in sequence.

TMT-B: A neuropsychological test that measures cognitive flexibility and executive functioning by alternating between numbers and letters in sequence.

TMT-A: The Trail Making Test Part A has no fixed theoretical maximum score; performance is measured as the time to completion (typically in seconds, with no upper limit) and the number of errors, with most healthy adults completing it in about 20-60 seconds.

TMT-B: The Trail Making Test Part B also has no fixed maximum score; it is scored primarily by completion time (usually in seconds, with no upper limit) and errors, with typical completion times for healthy adults around 40-180 seconds, depending on age and education.

both TMT-A and TMT-B, a higher score (longer completion time) indicates a worse performance.

2 minutes
WAIS-IV Coding
Tidsramme: 5 to 10 minutes

A neuropsychological subtest that assesses processing speed, visual-motor coordination, and sustained attention through a timed symbol-coding task.

The Coding subtest of the WAIS-IV does not have a fixed minimum or maximum raw score in terms of time-based performance; instead, raw scores typically range from 0 up to around 100-110 correct symbol-digit pairings, depending on the number of items attempted and accuracy.

A higher score means a better performance

5 to 10 minutes
Stroop Interference Task
Tidsramme: 5 minutes

A neuropsychological test that assesses inhibitory control and cognitive flexibility by requiring individuals to suppress automatic reading responses in favor of naming ink colors.

The Stroop test does not have fixed minimum or maximum raw scores, as performance is usually measured through reaction time (in seconds) and number of errors, particularly in the interference condition. n general, longer reaction times and more errors indicate poorer inhibitory control, while faster responses with fewer errors indicate better performance.

5 minutes
Rosenberg Scale
Tidsramme: 2 minutes

A self-report questionnaire that assesses global self-esteem through ratings of positive and negative self-beliefs.

Minimum score 0, maximum 30. Higher scores indicate higher global self-esteem, while lower scores reflect lower self-esteem.

2 minutes
Physical Self-Concept Inventory (ISP-25)
Tidsramme: 2 to 3 minutes
A self-report questionnaire that assesses individuals' perceptions of their physical self across dimensions such as physical ability, appearance, strength, and physical self-worth. Total score range from 25 to 125, higher scores indicating a more positive physical self-concept.
2 to 3 minutes
WHOQOL-Bref scale
Tidsramme: 2 to 3 minutes
A self-report questionnaire developed by the World Health Organization that assesses perceived quality of life across physical, psychological, social, and environmental domains. The WHOQOL-BREF is a 26-item self-report questionnaire scored across four domains (physical health, psychological health, social relationships, and environment), with each domain transformed to a 0-100 scale where higher scores indicate better perceived quality of life.
2 to 3 minutes
Social Functioning Scale (QFS)
Tidsramme: 2 to 3 minutes

A self-report questionnaire that assesses social functioning and community participation across domains such as social engagement, interpersonal behavior, recreation, and independent living.

The Social Functioning Scale is a self-report measure assessing social and community functioning, typically producing domain scores that are standardized (often converted to T-scores or z-scores) rather than a single fixed raw total score range, with higher scores indicating better social functioning.

2 to 3 minutes
Negative Symptom Scale (SNS)
Tidsramme: 1 to 2 minutes

A self-report questionnaire that assesses the severity of negative symptoms, including social withdrawal, reduced emotional expression, avolition, anhedonia, and alogia.

The SNS is a self-report scale with multiple items rated on Likert-type responses, yielding a total score range from 0 to 30, where higher scores indicate more severe negative symptoms.

1 to 2 minutes
Self-Stigma Index (ISMI)
Tidsramme: 2 to 3 minutes

A self-report questionnaire that assesses the extent to which individuals internalize stigma related to mental illness, including feelings of alienation, stereotype endorsement, discrimination, and social withdrawal.

The ISMI is a self-report questionnaire composed of multiple Likert-rated items, typically producing a mean or total score ranging from 1 to 4, where higher scores indicate greater internalized stigma.

2 to 3 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mirvat Hamdan-Dumont, MD, PhD, Centre Hospitalier Esquirol

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. oktober 2022

Primær færdiggørelse (Faktiske)

26. august 2024

Studieafslutning (Faktiske)

26. august 2024

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tennis ( physical activity)

Abonner