Heart DiseaseEarly Phase 1NCT01624818
Active With Heart Disease
A Early Phase 1 study testing Cardiac habilitation program in people with Heart Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Background: In Norway each year 130-150 children are born with heart disease that requires lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced physical capacity compared with healthy peers. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Heart Disease
- What is being tested?
- Cardiac habilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Dec 2015
- Phase
- Early Phase 1
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with heart disease in the age groups 6-7 years and 11-12 years with the need for lifelong medical treatment.
Who cannot join
- Children with serious mentally retardation and/or significant physical disabilities. Children and caregivers who does not speak norwegian or for other reasons have problems with communication that makes a interview difficult.
Trial locations and contacts
1 site in 1 country.
Asle Hirth, Cand. med contact
Norway1 site
Geilomo barnesykehus
Geilo, Buskerud, 3581
Anne- Britt Foss, bachelor i sykepleie, 0047 90888982, anfoss@ous-hf.no
About this study
Official title: Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital
Background: In Norway each year 130-150 children are born with heart disease that requires lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced physical capacity compared with healthy peers. Increased knowledge in the children themselves and the general public, along with psychosocial interventions improve the child's ability to cope with the consequences of their disease. Descriptions of the experiences that Norwegian children with heart disease and their parents have about participation in rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of children with chronic illness, and started in 2005 to welcome children with heart disease. At present there is no rehabilitation institutions in Norway that has a special group programs for children with heart disease. Geilomo want to establish such a group for children aged 6-7 years and 11-12 years.
Main objective: The investigators will use of methods to learn more about the following:
Read more
Study 1: The purpose is to generate knowledge about how children with heart disease and their relatives experience participation in a rehabilitation program at Geilomo children's hospital.
Overarching question: How do children with heart disease and their guardians to participate in a rehabilitation program, and the impact of this on their daily life afterwards?
Study 2: The purpose is to help a) to give the children an increased level of activity in the home environment.
Question: Will children with heart disease increase their activity levels at home after a stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will children with heart disease have improved their physical condition three months after a stay at Geilomo?
Work schedule: The project will have a duration of 3 years. The project will seek approval of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information sheet and consent form has been prepared. Data collection for the study 2AB can start in March 2013. The first interviews will be conducted after 3 months, in June 2013. Data collection is expected to be completed in December 2013. The analysis will take place in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3 pieces) and publication of results.
Method: In order to shed light on the problem in study 1, the investigators will use semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study 2a) To get information about their child's activity level in the home environment the investigators will use structured questionnaires. It is one form for children (36 persons) and another form for their parents (36 persons). Study 2b) All children (36 persons) conducting physical fitness test at the first visit and after three months. Children can be referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle Hirth (HUS) determines participation according to inclusion and exclusion criteria.
Parents submit a written consent on behalf of themselves and their children.
Scientific significance: This application describes two related studies, both of which are expected to provide important information that can provide better services for children with heart disease.
- Conditions
- Heart Disease
- Being tested
- Cardiac habilitation program
- Keywords
- coping, physical activity, psychosocial, children, heart disease, habilitation
- Medical subject headings
- Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac habilitation programBehavioural
physical activity three weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 2, 6-7 years | Experimental | 18 children (6-7 years) with heart disease participating in a rehabilitation programme in Geilomo childrens hospital Receives: Behavioral: Cardiac habilitation program |
| Group 1, 11-12 years | Experimental | 18 children(11-12 years) with heart disease participating in a rehabilitation programme at Geilomo childrens hospital. Receives: Behavioral: Cardiac habilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased level of physical activity
Measured: 3 months
Secondary outcomes (1)
Increased physical fitness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624818
- Sponsor's protocol ID
- 268289
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital
- ClinicalTrials.gov ID
- NCT01624818
- Acronym / sponsor ID
- 268289
- Conditions
- Heart Disease
- Keywords
- coping, physical activity, psychosocial, children, heart disease, habilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Jun 2012 (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.
Background: In Norway each year 130-150 children are born with heart disease that requires lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced physical capacity compared with healthy peers. Increased knowledge in the children themselves and the general public, along with psychosocial interventions improve the child's ability to cope with the consequences of their disease. Descriptions of the experiences that Norwegian children with heart disease and their parents have about participation in rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of children with chronic illness, and started in 2005 to welcome children with heart disease. At present there is no rehabilitation institutions in Norway that has a special group programs for children with heart disease. Geilomo want to establish such a group for children aged 6-7 years and 11-12 years.
Main objective: The investigators will use of methods to learn more about the following:
Study 1: The purpose is to generate knowledge about how children with heart disease and their relatives experience participation in a rehabilitation program at Geilomo children's hospital.
Overarching question: How do children with heart disease and their guardians to participate in a rehabilitation program, and the impact of this on their daily life afterwards?
Study 2: The purpose is to help a) to give the children an increased level of activity in the home environment.
Question: Will children with heart disease increase their activity levels at home after a stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will children with heart disease have improved their physical condition three months after a stay at Geilomo?
Work schedule: The project will have a duration of 3 years. The project will seek approval of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information sheet and consent form has been prepared. Data collection for the study 2AB can start in March 2013. The first interviews will be conducted after 3 months, in June 2013. Data collection is expected to be completed in December 2013. The analysis will take place in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3 pieces) and publication of results.
Method: In order to shed light on the problem in study 1, the investigators will use semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study 2a) To get information about their child's activity level in the home environment the investigators will use structured questionnaires. It is one form for children (36 persons) and another form for their parents (36 persons). Study 2b) All children (36 persons) conducting physical fitness test at the first visit and after three months. Children can be referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle Hirth (HUS) determines participation according to inclusion and exclusion criteria.
Parents submit a written consent on behalf of themselves and their children.
Scientific significance: This application describes two related studies, both of which are expected to provide important information that can provide better services for children with heart disease.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2, 6-7 years | Experimental | Behavioral: Cardiac habilitation program18 children (6-7 years) with heart disease participating in a rehabilitation programme in Geilomo childrens hospital |
| Group 1, 11-12 years | Experimental | Behavioral: Cardiac habilitation program18 children(11-12 years) with heart disease participating in a rehabilitation programme at Geilomo childrens hospital. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with heart disease in the age groups 6-7 years and 11-12 years with the need for lifelong medical treatment.
Key exclusion criteria (1 listed)
- Children with serious mentally retardation and/or significant physical disabilities. Children and caregivers who does not speak norwegian or for other reasons have problems with communication that makes a interview difficult.
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 |
|---|---|---|
| Cardiac habilitation programphysical activity three weeks | Behavioural | Group 1, 11-12 years, Group 2, 6-7 years |
Primary outcome
Increased level of physical activity
Time frame: 3 months
1 secondary outcome
Increased physical fitness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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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.
Asle Hirth, Cand. med contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cardiac habilitation program in people with Heart Disease, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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 21 Jun 2012. 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 Norway. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Merete S Engeseth, Master (0047 41566026, msalve@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased level of physical activity (time frame: 3 months). 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 21 Jun 2012.