Physical Activity and Functioning in Home Dialysis Patients
Aperçu de l'étude
Description détaillée
Aim 1: To determine levels of physical functioning, physical activity, incidence of frailty and inflammation status in prevalent home dialysis patients in the University of Utah Home Dialysis program and compare them to in-center hemodialysis patients who are matched for age, gender, comorbidities and dialysis vintage. Hypothesis 1: Patients on home therapies will have higher physical functioning, be more active and fewer will be frail compared to matched patients treated with in-center hemodialysis.
Aim 2: To determine the patterns of change in physical functioning and physical activity over the first 18 months of initiating dialysis therapy. Hypothesis 2: Physical functioning and physical activity will be maintained in patients initiating home dialysis therapy, whereas, those initiating in-center dialysis will deteriorate in physical functioning and physical activity.
Aim 3: To determine the effects of counseling and encouragement of physical activity in prevalent home dialysis patients on physical functioning, physical activity. Hypothesis 3: Compared to usual care, patients who are counseled and encouraged to participate in independent home walking exercise will improve physical functioning and health-related quality of life.
Aim 4: To determine the association of inflammation with physical functioning in home dialysis patients and with changes in physical activity. Hypothesis 4: Lower physical functioning is associated with inflammation and increased physical activity will improve physical functioning and reduce the associated inflammation.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- on dialysis for 3 months (for prospective study and for pilot intervention)
- 18 years of age
- ambulatory
- no progressive neuromuscular disease
- no orthopedic or rheumatologic problems that would be exacerbated by physical function testing
- English speaking
- able to understand and provide consent for participation
Exclusion Criteria:
- progressive neuromuscular disease that may result in limitations
- orthopedic or rheumatologic disease that may be exacerbated by physical function testing
- physical functioning
- unstable angina or angina upon exertion
- terminal illness with life expectancy less than 12 months
- MI or CABG within the last year
- NYHA Class III or IV CHF
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Physical Function/Activity
cross-sectional comparison study of physical function/activity, frailty and inflammation measures in prevalent home Dx and prevalent in-center hemodialysis patients. Subjects: Forty-five prevalent home dialysis patients will be recruited and tested once for all outcome measures. Forty-five prevalent in-center hemodialysis patients will be identified from prevalent patients in the University of Utah in-center dialysis system who are matched for gender, age, comorbidities and time on dialysis as the home dialysis patients who have been tested. Consenting patients will be tested for all outcome measures once and compared to the home dialysis group. |
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Aucune intervention: Incident Patients
Study 2: is a longitudinal cohort study of incident patients starting either home dialysis or in-center hemodialysis. Consenting patients will be tested upon initiation of dialysis therapy and every 6 months for 18 months to track physical functioning /activity, frailty and inflammation over time. |
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Autre: Independent Home Exercise
pilot study of independent home exercise training in home dialysis (PD only) patients.
Consenting patients will be tested at baseline, then randomized into exercise training or usual care (no prescribed change in activity levels) and retested after 3 months.
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Pilot study of independent home exercise training (walking or cycling exercise plus low level resistance exercise) for 3 months.
Patients will be given specific recommendations for type, frequency, duration and progression of their program and will be contacted weekly by study staff to assess progress and evaluation for any problems.
This is a 3 month exercise training intervention in 15 subjects (and 15 no-exercise controls).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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change in short physical performance battery
Délai: baseline, 3 months, 6 months 12 mo, 18 mo
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baseline, 3 months, 6 months 12 mo, 18 mo
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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change in inflammation
Délai: baseline, 6 mo, 12 mo, 18 mo
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baseline, 6 mo, 12 mo, 18 mo
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Patricia Painter, U of U PHYSICAL THERAPY - COH
Publications et liens utiles
Publications générales
- Painter P, Carlson L, Carey S, Paul SM, Myll J. Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):482-92. doi: 10.1016/s0272-6386(00)70202-2.
- Lo CY, Li L, Lo WK, Chan ML, So E, Tang S, Yuen MC, Cheng IK, Chan TM. Benefits of exercise training in patients on continuous ambulatory peritoneal dialysis. Am J Kidney Dis. 1998 Dec;32(6):1011-8. doi: 10.1016/s0272-6386(98)70076-9.
- Painter P, Messer-Rehak D, Hanson P, Zimmerman SW, Glass NR. Exercise capacity in hemodialysis, CAPD, and renal transplant patients. Nephron. 1986;42(1):47-51. doi: 10.1159/000183632.
- Cheema BS, Singh MA. Exercise training in patients receiving maintenance hemodialysis: a systematic review of clinical trials. Am J Nephrol. 2005 Jul-Aug;25(4):352-64. doi: 10.1159/000087184. Epub 2005 Jul 22.
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
Autres numéros d'identification d'étude
- IRB_00053828
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