NCT02803541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

June 14, 2016

Last Update Submit

October 2, 2023

Conditions

Keywords

chronic kidney diseaseexercisepediatricssummer camp

Outcome Measures

Primary Outcomes (1)

  • Change in 6 minute walk distance

    The change in 6MWT distance measured in feet from Baseline to Day 12

    Baseline , Day 12

Secondary Outcomes (3)

  • Change in SPPC scores from Baseline to Day 12

    Baseline, Day 12

  • Exertion perception from the 6 minute walk

    Baseline, day 12

  • Is 12 days of increased exercise long enough to see changes in endurance?

    Baseline, day 12

Study Arms (1)

12 day mainstream summer camp experience

EXPERIMENTAL

The 12 day mainstream camp experience involves increased exercise from baseline at home. Can this exercise and peer contact improve physical endurance as measured by the 6 minute walk test and self concept as measured by a modified Harter scale

Behavioral: 12 day mainstream summer camp experience

Interventions

see arm description

12 day mainstream summer camp experience

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All kidney campers attending the Frost Valley YMCA and age matched otherwise healthy campers who provide consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frost Valley YMCA

Claryville, New York, 12725, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor Activity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • William Primack, MD

    Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 4, 2023

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations