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Completed

NCT Number: NCT00363961

Resistance Training During Maintenance Dialysis

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.

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Key information

Conditions

End Stage Renal Disease Atrophy Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02111, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Resistance exercise

Behavioral

resistance exercise vs sham comparison

Other names: strength training

Primary outcomes

  1. - Physical function (short physical performance battery)

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2006
Registry last updated
Dec 10, 2009

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.

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