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

September 23, 2010 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54505
        • Recruiting
        • University Hospital, Children's Hospital
        • Sub-Investigator:
          • Pierre Bordigoni, Pr
        • Sub-Investigator:
          • Pierre Lascombes, Pr
        • Sub-Investigator:
          • Pierre Monin, Pr
        • Sub-Investigator:
          • Bruno Leheup, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
health-related quality of life measurement
Time Frame: 2 points: on the first and last day of hospitalization
2 points: on the first and last day of hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
satisfaction with care measurement
Time Frame: 1 point: 15 days after hospital discharge
1 point: 15 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 23, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AC-2008-HO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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