Resistance Training During Maintenance Dialysis

NCT00363961 | Completed DMC

• 1 other identifier: R03DK064825
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

End stage renal disease; Maintenance dialysis; Resistance exercise; Muscle wasting; Disability

Outcome Measures

Primary Outcomes (1)

• - Physical function (short physical performance battery)

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

1

EXPERIMENTAL

resistance exercise

Behavioral: Resistance exercise

2

SHAM COMPARATOR

flexibility exercises

Behavioral: Resistance exercise

Interventions

Resistance exercise BEHAVIORAL

resistance exercise vs sham comparison

Also known as: strength training

1; 2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Muscular Atrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carmen Castaneda-Sceppa, MD, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: April 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 10, 2009

Record last verified: 2009-12

Locations

US (1)