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

Hospitalization Clinical Trial

— ACTIVHOP  

Official title:

ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00828217
• Other study ID #: AC-2008-HO
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2009
• Last updated: September 23, 2010
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: September 2010
• Source: Central Hospital, Nancy, France
• Contact: Elodie Speyer, PhD student
• Phone: +33383683558
• Email: elodie.speyer[@]medecine.uhp-nancy.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hospitalization

Intervention

Other:
• adapted physical activity
one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital

Locations

Country	Name	City	State
France	University Hospital, Children's Hospital	Vandoeuvre Les Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Association pour la promotion du sport chez l'enfant malade (APSEM), University of Nancy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health-related quality of life measurement		2 points: on the first and last day of hospitalization	No
Secondary	satisfaction with care measurement		1 point: 15 days after hospital discharge	No