Adapted Physical Activity, Health-Related Quality of Life and Satisfaction With Care in Hospitalized Children - Full Text View

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

This study is currently recruiting participants.

Verified by Central Hospital, Nancy, France, January 2009

First Received: January 22, 2009 No Changes Posted

Sponsors and Collaborators:	Central Hospital, Nancy, France University of Nancy CHU Nancy, Epidémiologie et Evaluation Cliniques, Nancy, France Association pour la promotion du sport chez l'enfant malade (APSEM)
Information provided by:	Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:	NCT00828217

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:	Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Children's Health

U.S. FDA Resources

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:	624
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
with APA: Experimental Children have adapted physical activity during their hospitalization	Other: adapted physical activity one session of adapted physical activiy per day (30 minutes each session), during the whole stay at the hospital
without APA: No Intervention 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:
- Medecine Infantil 1 et 3(paediatrics)
- Medecine Infantile 2 (hemato-oncology, immunolgy department)
- Chirurgie orthopedique et Brûlés (orthopedic 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

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

CHU Nancy, Epidémiologie et Evaluation Cliniques, Nancy, France

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, EA4003, Public health School, Faculty of Medicine
Study Chair:	Anne Vuillemin, PhD	Nancy-University, EA4003, Public health School, Faculty of Medicine
Study Chair:	Aline Herbinet, PhD	APSEM

More Information

No publications provided

Responsible Party:	University Hospital of Nancy ( Chastagner Pascal, MD, PhD )
Study ID Numbers:	AC-2008-HO
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00828217 History of Changes
Health Authority:	France: Institutional Ethical Committee; France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on September 10, 2009