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

22. juni 2016 opdateret af: University of California, San Francisco

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • San Francisco, California, Forenede Stater, 94122
        • UCSF

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 20 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 1 month after starting renal replacement therapy for the first time.
  • 3 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CKD Stages 1-4
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.
Eksperimentel: ESRD on Dialysis
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.
Eksperimentel: Kidney Transplant recipients
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Physical Activity
Tidsramme: Baseline, 12 weeks
Participants will measure physical activity in the form of daily steps using a pedometer
Baseline, 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

3. januar 2011

Først indsendt, der opfyldte QC-kriterier

4. januar 2011

Først opslået (Skøn)

5. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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