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Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children (ACTIVHOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Nancy
Association pour la promotion du sport chez l'enfant malade (APSEM)
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00828217
First received: January 22, 2009
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Hospitalization
Other: adapted physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • health-related quality of life measurement [ Time Frame: 2 points: on the first and last day of hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • satisfaction with care measurement [ Time Frame: 1 point: 15 days after hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: with APA
Children have adapted physical activity during their hospitalization
Other: adapted physical activity
one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital
No Intervention: without APA
Children don't have adapted physical activity during their hospitalization

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828217

Contacts
Contact: Elodie Speyer, PhD student +33383683558 elodie.speyer@medecine.uhp-nancy.fr

Locations
France
University Hospital, Children's Hospital Recruiting
Vandoeuvre Les Nancy, France, 54505
Sub-Investigator: Pierre Bordigoni, Pr         
Sub-Investigator: Pierre Lascombes, Pr         
Sub-Investigator: Pierre Monin, Pr         
Sub-Investigator: Bruno Leheup, Pr         
Sponsors and Collaborators
Central Hospital, Nancy, France
University of Nancy
Association pour la promotion du sport chez l'enfant malade (APSEM)
Investigators
Principal Investigator: Pascal Chastagner, MD, PhD University Hospital of Nancy, Children's Hospital
Study Chair: Serge Briançon, Pr Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
Study Chair: Anne Vuillemin, PhD Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
Study Chair: Aline Herbinet, PhD APSEM
  More Information

No publications provided

Responsible Party: Chastagner Pascal, MD, PhD, University Hospital of Nancy
ClinicalTrials.gov Identifier: NCT00828217     History of Changes
Other Study ID Numbers: AC-2008-HO
Study First Received: January 22, 2009
Last Updated: September 23, 2010
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
adapted physical activity
hospital
health-related quality of life
satisfaction with care
child
adolescent
randomized controlled trial
physical activity
quality of life

ClinicalTrials.gov processed this record on November 25, 2014