- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01602718
Physical Activity and Functioning in Home Dialysis Patients
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: 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. |
|
Nessun intervento: 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. |
|
Altro: 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.
|
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).
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
change in short physical performance battery
Lasso di tempo: baseline, 3 months, 6 months 12 mo, 18 mo
|
baseline, 3 months, 6 months 12 mo, 18 mo
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
change in inflammation
Lasso di tempo: baseline, 6 mo, 12 mo, 18 mo
|
baseline, 6 mo, 12 mo, 18 mo
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Patricia Painter, U of U PHYSICAL THERAPY - COH
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IRB_00053828
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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