NCT01602718

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

May 16, 2012

Last Update Submit

November 16, 2016

Conditions

Diabetes

Keywords

physical activityphysical performanceESRDhome dialysis

Outcome Measures

Primary Outcomes (1)

  • change in short physical performance battery

    baseline, 3 months, 6 months 12 mo, 18 mo

Secondary Outcomes (1)

  • change in inflammation

    baseline, 6 mo, 12 mo, 18 mo

Study Arms (3)

Physical Function/Activity

NO INTERVENTION

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.

Incident Patients

NO INTERVENTION

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

OTHER

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.

Other: exercise training

Interventions

exercise trainingOTHER

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).

Also known as: Independent Home Exercise Training
Independent Home Exercise

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • on dialysis for 3 months (for prospective study and for pilot intervention)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 10692275BACKGROUND

  • 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.

    PMID: 9856517BACKGROUND

  • 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.

    PMID: 3510400BACKGROUND

  • 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.

    PMID: 16088076BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusMotor ActivityKidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patricia Painter

    U of U PHYSICAL THERAPY - COH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Faculty

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 21, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11