- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Vandoeuvre Les Nancy, Frankrike, 54505
- Rekrytering
- University Hospital, Children's Hospital
-
Underutredare:
- Pierre Bordigoni, Pr
-
Underutredare:
- Pierre Lascombes, Pr
-
Underutredare:
- Pierre Monin, Pr
-
Underutredare:
- Bruno Leheup, Pr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: with APA
Children have adapted physical activity during their hospitalization
|
one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital
|
|
Inget ingripande: without APA
Children don't have adapted physical activity during their hospitalization
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
health-related quality of life measurement
Tidsram: 2 points: on the first and last day of hospitalization
|
2 points: on the first and last day of hospitalization
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
satisfaction with care measurement
Tidsram: 1 point: 15 days after hospital discharge
|
1 point: 15 days after hospital discharge
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: 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
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- AC-2008-HO
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .