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.

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Key information

Conditions

Diabetes Behavior Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

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 names: Independent Home Exercise Training

Primary outcomes

change in short physical performance battery

Time frame: baseline, 3 months, 6 months 12 mo, 18 mo

Secondary outcomes

change in inflammation

Time frame: baseline, 6 mo, 12 mo, 18 mo

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

Baxter Healthcare Corporation

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: May 21, 2012
Registry last updated: Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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