NCT00828217

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

January 22, 2009

Last Update Submit

September 23, 2010

Conditions

Keywords

adapted physical activityhospitalhealth-related quality of lifesatisfaction with carechildadolescentrandomized controlled trialphysical activityquality of life

Outcome Measures

Primary Outcomes (1)

  • health-related quality of life measurement

    2 points: on the first and last day of hospitalization

Secondary Outcomes (1)

  • satisfaction with care measurement

    1 point: 15 days after hospital discharge

Study Arms (2)

with APA

EXPERIMENTAL

Children have adapted physical activity during their hospitalization

Other: adapted physical activity

without APA

NO INTERVENTION

Children don't have adapted physical activity during their hospitalization

Interventions

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

with APA

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • No written informed consent
  • Children hospitalized less than 3 days
  • Medical contra-indication to physical activity
  • Children already included in that study (former hospitalization)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Children's Hospital

Vandœuvre-lès-Nancy, 54505, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pascal Chastagner, MD, PhD

    University Hospital of Nancy, Children's Hospital

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Central Study Contacts

Elodie Speyer, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations