Investigate how physical fitness and activity evolve over time in paediatric burn patients, also in relation to function.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
- Skin and subcutaneous tissue disorders NEC
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in physical fitness, specifically aerobic capacity expressed as WRpeak
(WRpeak) and VO2peak (ml/min), also relative for weight (ml/kg/min)) over time,
from hospital discharge to 6 months post discharge.
Secondary outcome
Change from hospital discharge to 6 months post discharge in:
• Physical fitness
* Aerobic capacity
- Peak heart rate (HRpeak; beats per minute)
- Percentage heart rate recovery after 1 and 2 minutes (%HR01 and %HR02)
* Muscular strength
- Force (Newton) per muscle group
* Flexibility
- Range of motion (degrees) per movement
* Body composition
- BMI (kg/m2)
- Waist circumference (m)
- Percentage fat (free) mass
• Physical activity
- Score on activity questionnaire *Beweeggedrag*
- Accelerometry (counts)
• Health-Related Quality of life
- Score on the Burn Outcome Questionnaire
- Score on the PedsQL Multidimensional Fatigue Scale
To establish how well children are doing, the above parameters (main and
secondary) will be compared to Dutch age and sex-matched reference values.
Furthermore, the study parameters will be adjusted for confounders.
Background summary
With the marked improvement of survival of patients with burns, the ultimate
goal of rehabilitation is to assist individuals in returning to their
pre-injury functional status, while maximizing their emotional and cosmetic
outcomes. People survive burn injuries after an often extensive period of
physiological assault, decreased physical activity and an increased demand of
proteins leading to catabolism, especially of muscle mass. Loss of physical
fitness as a consequence of burn injury therefore seems inevitable. Indeed,
physical fitness has been found to be affected after burn injury and exercise
training can effectively improve physical fitness. However, knowledge is
incomplete, only pertaining to a small, specific group of patients, i.e.
children with very severe burns. If we are to optimise rehabilitation programs
to help children timely achieve their maximal, if not pre-injury, functional
status, after burn injury, we need to know how their fitness and activity
evolve and how this is related to their functioning.
Study objective
Investigate how physical fitness and activity evolve over time in paediatric
burn patients, also in relation to function.
Study design
Prospective observational longitudinal study
Study burden and risks
The risks and inconvenience of participation are kept as low as possible. The
physical fitness assessments are performed four times. As an important
component of physical fitness, aerobic capacity will be assessed with an
exercise test on a cycle ergometer. In stead of performing the usual exhaustive
cardiopulmonary exercise test, the Steep Ramp Test will be used. An important
difference between the SRT and usual cardiopulmonary exercise test is its
duration: the SRT takes between 2 and 3 min. excluding warm-up and cooling
down. The SRT is very well accepted by children, also if not healthy. The risks
for exercise tests are minimal. Additionally, before testing, a physician has
checked the health status of each participant and they are screened by way of
the Exercise Pre-participation Screening form. In case of contra-indications a
physician will be consulted and a child may be excluded from the exercise test.
During the exercise test, the heart rate will be supervised. The test will be
stopped in case of abnormal values. The other fitness assessments (muscular
strength, body composition, and flexibility) are safe and non-intensive. The
physical fitness assessments will take approximately 1 hour each time and they
will be scheduled in combination with routine follow-up appointments.
Physical activity monitoring with an accelerometer is without risk and the
inconvenience of wearing the accelerometer is low, as it is a very small and
low-weight device, worn as a waistband. Filling out the questionnaires will
take approximately 30 minutes each time, but can be done during one week at the
patients* and/or parents* convenience. In summary, risks are negligible and the
burden of participation seems minimal.
This study is only possible by including this specific paediatric population,
as burns have very specific, multidimensional consequences and children*s
physiological and psychological response differs from adults*. The group
benefit mainly is improvement in the domain of individualized rehabilitation
and with that better physical functional outcomes for paediatric burn patients
in the (near) future. Children can benefit individually by becoming aware of
their own fitness and activity levels and their importance.
van Swietenplein 1
Groningen 9728NT
NL
van Swietenplein 1
Groningen 9728NT
NL
Listed location countries
Age
Inclusion criteria
Eligible are children in the age between 6 and 18 years, who are admitted to one of the three Dutch Burn Centres with burns of at least 5% total body surface area or more and/or hospitalised for 2 weeks or more.
Exclusion criteria
- patients with extensive (pre-existing) morbidity unrelated to the burn injury, interfering with fitness
- children and/or their parents who are insufficiently proficient in Dutch
- no signed informed consent (by legal representatives (parents) and/or children if > 12 years)
* children with a contra-indication for exercise testing will not perform the cycling test, however, may otherwise be included.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL45917.099.13 |
Other | OND1353942 |