- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00828217
Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children (ACTIVHOP)
ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study
The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.
This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Vandoeuvre Les Nancy, Frankrig, 54505
- Rekruttering
- University Hospital, Children's Hospital
-
Underforsker:
- Pierre Bordigoni, Pr
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Underforsker:
- Pierre Lascombes, Pr
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Underforsker:
- Pierre Monin, Pr
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Underforsker:
- Bruno Leheup, Pr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Length of hospital stay (more than 3 days)
- Children or parents able to understand and read French
- No medical contra-indications to physical activity
Children hospitalized in 3 specific departments at Nancy Children's Hospital:
- Médecine Infantile 1 et 3(paediatrics)
- Médecine Infantile 2 (haematology-oncology, immunology department)
- Chirurgie orthopédique et Brûlés (orthopaedic surgery and Burned)
- Children and parents being agree to participate in the study
Exclusion Criteria:
- No written informed consent
- Children hospitalized less than 3 days
- Medical contra-indication to physical activity
- Children already included in that study (former hospitalization)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: with APA
Children have adapted physical activity during their hospitalization
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one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital
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|
Ingen indgriben: without APA
Children don't have adapted physical activity during their hospitalization
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
health-related quality of life measurement
Tidsramme: 2 points: on the first and last day of hospitalization
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2 points: on the first and last day of hospitalization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
satisfaction with care measurement
Tidsramme: 1 point: 15 days after hospital discharge
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1 point: 15 days after hospital discharge
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Pascal Chastagner, MD, PhD, University Hospital of Nancy, Children's Hospital
- Studiestol: Serge Briançon, Pr, Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
- Studiestol: Anne Vuillemin, PhD, Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
- Studiestol: Aline Herbinet, PhD, APSEM
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- AC-2008-HO
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Kliniske forsøg med adapted physical activity
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringFysisk aktivitet | Insulin resistens | Pubertet | PCOS (polycystisk ovariesyndrom)Forenede Stater
-
University of Vic - Central University of CataloniaIRIS-CC; AGAURAktiv, ikke rekrutterendePsykisk sundhedsproblemSpanien
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetFysisk aktivitetForenede Stater
-
The Miriam HospitalUkendtSlag | Stillesiddende livsstil | Iskæmisk angreb, forbigående | Dyrke motionForenede Stater
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Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAfsluttetKræft prostataFrankrig
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The University of Hong KongRekrutteringDemens | Plejerbyrde | Kognitiv svækkelse, mild | Demens, mildHong Kong
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Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological AssociationRekrutteringAutismespektrumforstyrrelse (ASD)Forenede Stater
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Cairo UniversityTilmelding efter invitation
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IVI BilbaoInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet