Resistance Training During Maintenance Dialysis

End Stage Renal Disease Clinical Trial

Official title:

Resistance Training During Maintenance Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363961
• Other study ID #: R03DK064825
• Secondary ID: R03DK064825
• Status: Completed
• Phase: N/A
• First received: August 10, 2006
• Last updated: December 9, 2009
• Start date: April 2004
• Est. completion date: August 2007

Study information

• Verified date: December 2009
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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:

1. A feasible and safe exercise modality for ESRD patients.

2. Will contribute to improved nutritional status and reduced systemic inflammation

3. Will result in improved quality of life

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Resistance exercise
resistance exercise vs sham comparison

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Physical function (short physical performance battery)		6 months	No
Secondary	Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living		6 months	No