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Physical Activity and Functioning in Home Dialysis Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Patricia Painter, University of Utah
ClinicalTrials.gov Identifier:
NCT01602718
First received: May 16, 2012
Last updated: May 17, 2012
Last verified: May 2012
History of Changes

May 16, 2012
May 17, 2012
June 2012
May 2015   (final data collection date for primary outcome measure)
change in short physical performance battery [ Time Frame: baseline, 3 months, 6 months 12 mo, 18 mo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01602718 on ClinicalTrials.gov Archive Site
change in inflammation [ Time Frame: baseline, 6 mo, 12 mo, 18 mo ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Physical Activity and Functioning in Home Dialysis Patients
Physical Activity and Functioning in Home Dialysis Patients

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
Other: exercise training
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 Name: Independent Home Exercise Training
  • No 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.

  • No 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.

  • 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.
    Intervention: Other: exercise training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01602718
IRB_00053828
No
Patricia Painter, University of Utah
University of Utah
Baxter Healthcare Corporation
Principal Investigator: Patricia Painter U of U PHYSICAL THERAPY - COH
University of Utah
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP