Clinical trial NCT01602718: Physical Activity and Functioning in Home Dialysis Patients
Official title: Physical Activity and Functioning in Home Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: physical activity
physical performance
ESRD
home dialysis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare physical activity levels and physical functioning in patients treated with home dialysis vs. those treated with in-center dialysis. The investigators will first compare prevalent patients, and will also compare the two groups longitudinally in incident patients over the first 18 months of beginning the dialysis treatments. Patients will be tested for physical functioning using standard performance-based testing such as gait speed, chair stand, balance test, as well as self-reported limitations in activities of daily living. The investigators will monitor physical activity using step counters and activity questionnaires. Blood samples will be drawn at each testing time to measure inflammatory markers. A pilot study of home dialysis patients will be done to determine the effects of an independent home-based exercise program on physical functioning and inflammatory markers. For this pilot study, 30 patients will be randomized into exercise intervention and usual care with testing at baseline and again after 3 months of the intervention.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in short physical performance battery
timeFrame: baseline, 3 months, 6 months 12 mo, 18 mo
Secondary outcomes:
measure: change in inflammation
timeFrame: baseline, 6 mo, 12 mo, 18 mo
Other outcomes:
Locations:
Study officials:
affiliation: U of U PHYSICAL THERAPY - COH
name: Patricia Painter
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.