Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02803541 |
| Other study ID # |
16-1416 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2016 |
| Est. completion date |
July 2016 |
Study information
| Verified date |
October 2017 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: Most children and adolescents with chronic kidney disease (CKD) have much less
physical endurance than their age matched peers, are at high risk for premature
cardiovascular disease, and have a poor self image in part due to limited peer contact.
Sustained exercise in adults with CKD improves endurance and decreases cardiovascular risk.
Minimal data exists in pediatric CKD patients. This study will show whether 12 days of
increased exercise at a summer camp will improve endurance as measured by the distance walked
in 6 minutes and self concept as measured by a short standardized questionaire (Harter
scale).
The study will occur at the Frost Valley YMCA in the Catskills where in 2, 12 day sessions a
total of 25-30 kidney campers are mainstreamed in the general camp population of about 500.
Mainstreaming means that the kidney camper will live in a cabin with 8-10 age matched peers
and participate as much as possible in all camp activities with their bunkmates. The kidney
program at Frost Valley provides hemo and peritoneal dialysis, as well as caring for children
with less advanced CKD and post transplant.
Participants will have activity measured before and duringcamp by wearing a pedometer. The
distance walked in 6 minutes (a 6 minutewalk test) will be measured at onset and completion
of the 12 day camp experience. A standardized questionaire on self concept will also be
administered at the onset and completion of camp.
Description:
BACKGROUND:
Children and adolescents with CKD have high rates of hospitalization, and those with
End-Stage Renal Disease (ESRD) have a remaining life expectancy of about 20 years with
increased risk of premature death due to cardiovascular disease. Most have much less physical
endurance than their age matched peers with the degree of underperformance loosely correlated
with the severity of their renal disease. Cardiovascular disease, chronic inflammation,
anemia, low muscular strength and/or bone disease are among the factors considered
responsible for the poor physical conditioning. However, the investigators hypothesize that
the most important cause is inactivity caused by a varying combination of parental
'protection', limited or poor peer inaction, and patient choice. In addition, children who
require chronic hemodialysis have an enforced 10-14 hours weekly of enforced inactivity.
Cardiovascular morbidity is commonly associated with chronic kidney disease and physical
endurance is a measure of cardiovascular health. In addition many children with chronic
kidney disease demonstrate poor self-concept, in part related to their lack of physical
endurance and limited peer contact.
Multiple studies of adults with chronic kidney disease have documented poor physical
conditioning and function. Over the past decade, many studies have demonstrated in adults
with CKD a significant benefit of regular exercise on physical fitness, walking capacity,
blood pressure, and health related quality of life. Several small studies have shown a modest
improvement in children and adolescents with CKD but these studies have had high drop-out
rates and problematic compliance.
A 2012 study by Akber et al using pedometer measurements showed that over a 7 day period,
children, adolescents, and young adults with CKD (n=44) on average walked about 50% less than
expected using data collected by NHANES as a standard. Females walked less than males and
older children were less active than younger children. On a 6 minute walk test, males scored
< 2 standard deviation below the expected mean and females <4 standard deviation below the
mean. There was no measured difference between stage of CKD, dialysis, or transplant status.
In 1975 the Ruth Gottscho Kidney Foundation partnered with the Albert Einstein College of
Medicine and the Frost Valley YMCA to develop the first summer camp program capable of
performing hemodialysis and caring for children with chronic kidney disease. One of the
guiding principles of this program is that kidney campers (as well as some children with
other chronic illnesses) are mainstreamed in with the general camp population and participate
in the same activities as their age matched peers. Each summer, there are 4 two week camp
session with about 500 campers attending each session. The program has run each summer since
1975, and the enrollment of kidney campers has varied from 25 to 50 each summer. The Frost
Valley YMCA is located in the Catskill Mountains approximately 120 miles from New York City
and is spread over about 2000 acres.
Informal observation of the kidney campers indicates that many show improved physical
endurance during their camp stay, and a study done early in the program's history
demonstrated an improved self-esteem. , A study using the Piers Harris test of self-concept
evaluated 24 chronic dialysis children during the Summer of 1976 and compared them to 76
regular campers. On arrival at camp the dialysis campers had a lower self-concept than the
regular campers (P<.01). The same children were evaluated at the end of camp. Both groups
improved their self-concept (P<0.02) but the dialysis campers showed greater improvement.
(P<0.01) This study was presented at the 1977 Clinical Dialysis and Transplant Forum.
The investigators hypothesize that during their time at camp the kidney campers will improve
their physical endurance and their self-concept; which will be assessed objectively through
physical fitness/function and psychometric assessments. The investigators hope to do this in
a way that interferes as little as possible with the camp experience yet is educational and
fun for the kidney campers and their peers.
The ultimate objective of this pilot study is to increase awareness that children with CKD
should be physically active, can enjoy being part of a program with their peers, and may
benefit physically and mentally from it.
METHODS:
This pilot study designed in close collaboration between the UNC Kidney Center and the UNC
Department of Exercise Science and will occur during the first two 12 day camp sessions at
the Frost Valley YMCA during the Summer of 2016.
Campers range in age from 8 to 17 years. Each kidney camper and age matched healthy controls
(bunkmates) will be provided with a pedometer before camp arrival and will be asked to wear
it throughout each day in the week before camp in order to record their physical activity
level. Participants will also be asked to record screen time during the week prior to
beginning the camp. Participants will be asked to wear the pedometer during their camp stay,
except during waterfront activities, and the data recorded. The investigators hope to enroll
all kidney campers (estimate 25-40 individuals) and approximately 70-100 control campers.
The Omron 321 pedometer was chosen because it retains seven-days of data, is inexpensive, and
has been previously shown to be a valid and reliable indicator of physical activity.
On the day of, or the first day after camp arrival, each kidney camper along with his/her
bunkmates will be asked to complete a 6 minute walk test (6MWT). A standardized chart to
self-report their perceived exertion at the end of the walk will be used. Pulse upon
completion of the 6MWT and 1 minute later will be measured. Each child will wear a portable
pulse oximeter during the walk. The investigators hypothesize that the kidney campers will
increase their activity at camp compared to their activity at home as measured by the
pedometer, and also that they will be able to ambulate further as measured by the 6MWT with
less perceived exertion and possibly lower post 6MWT pulse rate at the end of the camp
session as compared to the beginning of camp.
The 6MWT test was chosen as the primary test measurement in consultation with the Exercise
Science Department faculty and camp administrative staff as there is considerable normative
data in healthy children, it is non-invasive, and its administration can easily fit into the
camp program.
Having the kidney campers participate with their bunkmates in the 6MWT will provide
motivation for campers to perform at as high a level as possible, yet not single the kidney
campers out as special or specifically as research subjects. Research data will be collected
only for those campers for whom consent/assent has been obtained.
Similarly, data for the control campers will be instructive as to whether a relatively short
period of increased activity (12 days) will allow measured changes in their 6MWT.
In order to be time efficient and fit in with the camp environment, rather than the standard
6MWT which is classically done in a hallway between 2 cones separated by 20 meters, the
campers will walk (not run) along the camp circle from approximately the laundry area to
Biscuit Hall (modified 6MWT). This is a relatively level paved path (net elevation rise ~15
feet) about 1500 feet in distance and is estimated to take the average camper about 6
minutes. Any who reach Biscuit Hall earlier, will do laps around Biscuit until the 6 minutes
is up. The course will be carefully measured and marked so that distances achieved will be
accurately ascertained.
The 6MWT will be repeated in the identical fashion shortly before the end of the camp
session, at approximately the same time of day.
Any child who becomes unusually fatigued during the modified 6MWT, will be encouraged to rest
until he or she is ready to continue.
A short standardized survey to measure self-concept will be given to the kidney campers and
to control campers to be completed upon arrival and shortly prior to leaving camp using the
Harter Self Perception Profile for Children (SPPC).
Camp physical forms will be used to determine age, weight, and height for control campers and
be directly measured for the kidney campers.
STATISTICS The primary data collected will be the distance traveled on the 6MWT. Each child
will serve as his/her own control for paired t-test analysis. Secondary data, which will
emphasize the kidney campers, will be perceived exertion and self concept. In both groups, if
possible, correlations will be drawn between activity levels prior to camp, performance on
the 6MWT, and measurement of self-concept. Also, group analyses will be done with comparisons
to previously published standard data.
As this is a pilot project and little data exists on the activity levels of children with
kidney disease and no similar study has ever been done, it is difficult to predict what
changes in activity will be seen. Consequently power calculations are not provided.
Similarly, most studies of exercise use periods considerably longer than 12 days, so it is
possible that 12 days is insufficient to see a measureable change in the 6MWT.
Although all campers in the bunk or village will be asked to participate in the 6MWT, only
data from those campers whose families have provided consent and campers who have provided
assent will be used for analysis. If sufficient non-kidney campers participate, data can be
analyzed in a similar manner to measure the impact of the camp experience on their physical
fitness and self-concept. In this situation, data regarding screen time pre camp as well as
the pedometer measurements pre-camp may be instructive.
