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Resistance Training During Maintenance Dialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease focused on measuring End stage renal disease, Maintenance dialysis, Resistance exercise, Muscle wasting, Disability

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female ESRD patients over 30 years of age ESRD patients undergoing maintenance hemodialysis 3x/wk for at least 3 months Willing to be randomized to either study group Compliance with at least 80% of the dialysis sessions Exclusion Criteria: Unstable cardiovascular disease Any uncontrolled chronic condition Cardiac surgery, myocardial infarction, joint replacement, or low extremity fracture within the previous 6 months Severe cognitive impairment resulting in inability to understand and provide written informed consent form and or follow instructions Current resistance training Low extremity amputees

Sites / Locations

  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

resistance exercise

flexibility exercises

Outcomes

Primary Outcome Measures

- Physical function (short physical performance battery)

Secondary Outcome Measures

Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living

Full Information

First Posted
August 10, 2006
Last Updated
December 9, 2009
Sponsor
Tufts University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00363961
Brief Title
Resistance Training During Maintenance Dialysis
Official Title
Resistance Training During Maintenance Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tufts University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a rising incidence of kidney failure in the US, with poor outcomes and high cost. End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and the underlying systemic inflammatory response developed during the course of chronic kidney disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality. Muscle wasting, impaired functional capacity and poor quality of life are the most important factors associated with malnutrition and inflammation in renal failure. We have shown in pre dialysis patients with moderate chronic renal insufficiency that the anabolic effects of resistance exercise training result in significant improvements in protein utilization, nutritional status and functional capacity even in the context of anorexia and prescribed low protein diets. Therefore, we propose to develop, test and implement a progressive resistance exercise routine for ESRD patients during the hemodialysis session. By implementing such intervention, we hope to offer a therapeutic strategy that can be incorporated to the standard of care of ESRD patients by working in conjunction with the dialysis unit staff.
Detailed Description
The hypotheses to be investigated are that, compared to ESRD patients on maintenance dialysis receiving stretches only, the addition of 30-45 min of progressive resistance training during the hemodialysis session will counteract the burden of renal disease and will result in: A feasible and safe exercise modality for ESRD patients. Will contribute to improved nutritional status and reduced systemic inflammation Will result in improved quality of life

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End stage renal disease, Maintenance dialysis, Resistance exercise, Muscle wasting, Disability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
resistance exercise
Arm Title
2
Arm Type
Sham Comparator
Arm Description
flexibility exercises
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Other Intervention Name(s)
strength training
Intervention Description
resistance exercise vs sham comparison
Primary Outcome Measure Information:
Title
- Physical function (short physical performance battery)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female ESRD patients over 30 years of age ESRD patients undergoing maintenance hemodialysis 3x/wk for at least 3 months Willing to be randomized to either study group Compliance with at least 80% of the dialysis sessions Exclusion Criteria: Unstable cardiovascular disease Any uncontrolled chronic condition Cardiac surgery, myocardial infarction, joint replacement, or low extremity fracture within the previous 6 months Severe cognitive impairment resulting in inability to understand and provide written informed consent form and or follow instructions Current resistance training Low extremity amputees
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Castaneda-Sceppa, MD, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Resistance Training During Maintenance Dialysis

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