Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease

NCT01270529 | Completed Results

• 1 other identifier: 10-03869
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report participation in physical activity that falls short of recommended levels of physical activity; Children on dialysis will be less active. Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will be related to their disease or its treatment; those who are less active will endorse more barriers. Hypothesis #3: Patients will increase their participation in physical activity in response to a pedometer-based 12 week intervention. Baseline level of physical activity and magnitude of increase in physical activity will be more closely associated with change in physical functioning and performance than stage of kidney disease or type of renal replacement therapy. Exercise capacity of the child will be measured by the six minute walk test whereby the subject will asked to walk as far as possible in 6 minutes in a straight corridor. Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy. Physical functioning or Health Related Quality of Life will be assessed self reported/ parent proxy reliable and validated questionnaire specifically designed for child with chronic kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or parents will also be asked to fill out a questionnaire on barriers to physical activity on their first visit. Physical activity will be measured in the form of daily steps. The child will wear the pedometer for the first week to assess his/her baseline level of activity. Then the child will continue to wear the pedometer for another 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and motivate the participant. After 12 weeks of the pedometer-based intervention to increase physical activity, physical performance, body composition and physical functioning (as described above) will be measured once again to assess the effect of increased physical activity on a second visit.

Conditions

Chronic Kidney Disease

Keywords

Physical Activity; Physical Performance; Physical Functioning; CKD; ESRD; Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity

  Participants will measure physical activity in the form of daily steps using a pedometer

  Baseline, 12 weeks

Study Arms (3)

CKD Stages 1-4

EXPERIMENTAL

Other: Increasing Physical activity

ESRD on Dialysis

EXPERIMENTAL

Other: Increasing Physical activity

Kidney Transplant recipients

EXPERIMENTAL

Other: Increasing Physical activity

Interventions

Increasing Physical activity OTHER

The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.

CKD Stages 1-4; ESRD on Dialysis; Kidney Transplant recipients

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients, male and female, aged 6-20 years.
• Chronic kidney disease stages 2-4 and ESRD on peritoneal dialysis or hemodialysis and kidney transplantation.
• Patients who can follow simple commands.
• English and Spanish speaking only.

You may not qualify if:

• Patients hospitalized in the past 1 month.
• Patients hospitalized in the past I month for infection.
• Patients hospitalized in the past 1 month post peritoneal or hemodialysis catheter placement for the first time.
• month after starting renal replacement therapy for the first time.
• months post kidney transplantation.
• In the opinion of the investigator too ill to participate.
• Unwilling to participate.
• Language barrier.
• Patient with any signs of active infection, shortness of breath, trauma or injury to the legs or feet or those undergoing cardiac evaluation.
• Patients unable to verbalize discomfort or developmental delay will not be included.
• Patients with respiratory distress or on oxygen will be excluded.
• Parents or subjects unable to afford transportation for the 2 scheduled visits will also be excluded.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Kirsten Johansen
• Organization: University of California, San Francisco

kirsten.johansen@ucsf.edu

415-221-4810

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 4, 2016
• Results First Posted: August 4, 2016

Record last verified: 2016-06

Locations

US (1)