HospitalizationACTIVHOPNCT00828217
Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children
A study testing adapted physical activity in people with Hospitalization, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hospitalization
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- No written informed consent
- Children hospitalized less than 3 days
- Medical contra-indication to physical activity
- Children already included in that study (former hospitalization)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Children's Hospital
Vandœuvre-lès-Nancy, 54505
Pierre Bordigoni, Pr
Pierre Lascombes, Pr
About this study
Official title: 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.
- Conditions
- Hospitalization
- Being tested
- adapted physical activity
- Keywords
- adapted physical activity, hospital, health-related quality of life, satisfaction with care, child, adolescent, randomized controlled trial, physical activity, quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
one session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital
| Study group | Role | What they receive |
|---|---|---|
| with APA | Experimental | Children have adapted physical activity during their hospitalization Receives: Other: adapted physical activity |
| without APA | No intervention | Children don't have adapted physical activity during their hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related quality of life measurement
Measured: 2 points: on the first and last day of hospitalization
Secondary outcomes (1)
satisfaction with care measurement
Measured: 1 point: 15 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nancy, Association pour la promotion du sport chez l'enfant malade (APSEM)
- Investigators
- Pascal Chastagner, MD, PhD, Principal investigator, University Hospital of Nancy, Children's HospitalSerge Briançon, Pr, Study chair, Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, FranceAnne Vuillemin, PhD, Study chair, Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, FranceAline Herbinet, PhD, Study chair, APSEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828217
- Sponsor's protocol ID
- AC-2008-HO
- Acronym
- ACTIVHOP
- Status last verified
- Sep 2010
- First submitted
- 22 Jan 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00828217
- Acronym / sponsor ID
- ACTIVHOP / AC-2008-HO
- Conditions
- Hospitalization
- Keywords
- adapted physical activity, hospital, health-related quality of life, satisfaction with care, child, adolescent, randomized controlled trial, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Nancy, Association pour la promotion du sport chez l'enfant malade (APSEM)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with APA | Experimental | Other: adapted physical activityChildren have adapted physical activity during their hospitalization |
| without APA | No intervention | –Children don't have adapted physical activity during their hospitalization |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
- Children and parents being agree to participate in the study
Key exclusion criteria (4 listed)
- No written informed consent
- Children hospitalized less than 3 days
- Medical contra-indication to physical activity
- Children already included in that study (former hospitalization)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted physical activityone session of adapted physical activity per day (30 minutes each session), during the whole stay at the hospital | Other | with APA |
Primary outcome
health-related quality of life measurement
Time frame: 2 points: on the first and last day of hospitalization
1 secondary outcome
satisfaction with care measurement
Time frame: 1 point: 15 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Chastagner, MD, PhD principal investigator
University Hospital of Nancy, Children's Hospital
Serge Briançon, Pr study chair
Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
Anne Vuillemin, PhD study chair
Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Hospitalization, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie Speyer, PhD student (+33383683558, elodie.speyer@medecine.uhp-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health-related quality of life measurement (time frame: 2 points: on the first and last day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.