- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01270529
Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94122
- UCSF
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: 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.
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Physical Activity
Délai: Baseline, 12 weeks
|
Participants will measure physical activity in the form of daily steps using a pedometer
|
Baseline, 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10-03869
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Maladie rénale chronique
-
PfizerComplétéLeucémie, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) PositifFrance, États-Unis, Canada, Espagne, Tchéquie, Singapour, Thaïlande, Danemark, Norvège, Corée, République de, Finlande, Hongrie, Suède, Pays-Bas, Italie, Allemagne, Ukraine, Afrique du Sud, Taïwan, Australie, Belgique, Israël, Mexique, Pologn... et plus
Essais cliniques sur Increasing Physical activity
-
University Hospital, ToulouseActif, ne recrute pasAccident vasculaire cérébralFrance
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts...ComplétéCancer du sein | Survivante du cancer du sein | Traqueurs de condition physiqueÉtats-Unis
-
Rabin Medical CenterRésiliéDiabète de type 1Israël
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationComplétéCancer du poumon, non à petites cellulesCanada
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...RecrutementHémophilie A | Hémophilie BBelgique