Physical Activity and Functioning in Home Dialysis Patients
Condition: Diabetes
Study type: Interventional

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.
    

Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): 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).
Other intervention name(s): Independent Home Exercise Training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; physical performance; ESRD; home dialysis