Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02803541
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2016-06-14
Brief Title:
Does a Mainstream Summer Camp Experience Improve Pediatric Kidney Patients Physical Fitness and Self Concept
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Does a Mainstream Summer Camp Experience Improve Pediatric Kidney Patients Physical Fitness and Self Concept
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 andor 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 n44 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 programs 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 P01 The same children were evaluated at the end of camp Both groups improved their self-concept P002 but the dialysis campers showed greater improvement P001 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 fitnessfunction 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 hisher 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 consentassent 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 hisher 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
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 andor 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 n44 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 programs 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 P01 The same children were evaluated at the end of camp Both groups improved their self-concept P002 but the dialysis campers showed greater improvement P001 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 fitnessfunction 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 hisher 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 consentassent 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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None