Utrecht Spina Bifida And Graded Exercise (USAGE) Study part 2: Does training in ambulatory children with SB increase levels of physical fitness, energy cost of locomotion and daily physical activity?

Many studies have shown the association between levels of physical activity
(PA) and physical fitness (PF) and overall mortality and morbidity, not only in
adults, but also in children. While healthy children are already at risk for a
hypoactive lifestyle in this modern society, this is even more the case in
children with chronic disease or disability. In children and adolescents with
Spina Bifida (SB), small pilot studies have shown these children to be less
active, less fit and more obese than their healthy peers. Next to increased
health risk, these children also seem to be more fatigued during daily
activities, which might be related to both low levels of exercise capacity and
higher energy expenditure during activities which include ambulation. Earlier
studies looking at exercise programs for children with disability or chronic
disease have shown increased levels of fitness.

Primary objective:To evaluate the effects of a training program on physical
fitness, energy cost of locomotion and daily physical activity in ambulatory
children and adolescents with Spina Bifida
Secondary objectives: (1) evaluate physical fitness (body composition, muscular
strength and cardiorespiratory fitness), daily physical activity and energy
cost of locomotion, (2) explore the relationship between physical activity,
physical fitness and energy cost of locomotion, (3) determine which factors are
associated with physical activity, physical fitness and energy cost of
locomotion in ambulatory children and adolescents with Spina Bifida.

Prospective randomized clinical trial. The first (t=0) measurement will also be
used to answer question 1-3.

A training program aimed at improving both cardiorespiratory fitness and
efficiency of locomotion. The trainingprogram will take place in the
environment of the child, e.g. the home, school or nearby sport facility. The
type of training will be treadmill training, with intensity, frequency and
during individually tailored to the patient's ability.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Time to travel to the exercise lab, time to
undergo the tests and time to fill out questionnaires (Fatigue scale,
demographics and health related issues at the time of measurement).
Participants will perform a maximum VO2peak test and an energy cost of
locomotion assessment during a 6 minute walking test. Furthermore they will
undergo measurement of height, weight, skin folds, circumferences and muscle
strength. The physical activity monitor will be fitted and calibrated during
their visit to the lab. Physical activity monitors will be returned either by
mail or will be picked up at the home. Participants will be exercising twice a
week. Each candidate will receive an individually designed home training
program, based on the outcomes of maximum exercise testing. The risks of these
tests and training program are negligible. The benefits for these children are
participation in the training program. If the exercise program indeed has been
proven to be beneficial, the control group will receive training instructions,
to be used under supervision of their physical therapist, after the study has
been completed.