Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients

NCT01990495 | Completed Results

• 1 other identifier: E0915-R
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.

Conditions

Chronic Kidney Disease

Keywords

Renal failure; Exercise testing; Exercise training; Protein signaling; Skeletal muscle

Outcome Measures

Primary Outcomes (1)

• Maximal Oxygen Uptake

  The overall primary outcome for the study is maximal oxygen uptake. Maximal oxygen uptake is the amount of oxygen consumed by the body during maximal exercise. It is the gold standard expression for exercise capacity.

  3 months

Secondary Outcomes (2)

• Biopsy of the Quadriceps Muscle.

  3 Months

• Quality of Life Score

  3 months

Study Arms (2)

Exercise vs. usual care

ACTIVE COMPARATOR

The study involves two arms randomized to exercise and usual care groups

Other: Exercise training; Other: Usual Care

Usual care

ACTIVE COMPARATOR

This group will be randomized to receive usual clinical care. No other interventions will be assigned to this group.

Other: Usual Care

Interventions

Exercise training OTHER

Subjects will participate in a center-based and home exercise training program for 3 months.

Exercise vs. usual care

Usual Care OTHER

This group will serve as control subjects. They will receive only usual clinical care.

Exercise vs. usual care; Usual care

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 55-80 years undergoing maintenance hemodialysis (MHD) for at least three months and without other active/uncontrolled disease will be studied.
• Exercise and usual care groups will be matched by age, body mass index (BMI), MHD duration, and protein intake using a stratified randomization approach.
• Subjects will be required to be in the peak VO2 range of 10 to 20 ml/kg/min, equivalent to moderate functional impairment in patients with heart failure.
• Subjects will be required to have dialysis treatment for \>3 months with an average Kt/V 1.2, and be able to perform exercise safely.

You may not qualify if:

• Current activity \> 2 hrs/wk of moderate intensity exercise, temporary vascular access, uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy, severe obesity (BMI \> 35), alcoholism or other recreational drug use, unstable cardiac disease (abnormal exercise test, angina, uncontrolled arrhythmias or myocardial infarction within three months), peripheral vascular disease (claudication with exercise), lung, liver or intestinal disease, those who are medically unstable and subjects who have received anabolic, catabolic or cytotoxic medications in the past 3 months.
• The investigators will also exclude subjects with excessive previous exposure to radiation.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (2)

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

  PMID: 35018639 DERIVED

• Myers J, Chan KN, Chen Y, Lit Y, Massaband P, Kiratli BJ, Tan JC, Rabkin R. Association of physical function and performance with peak VO2 in elderly patients with end stage kidney disease. Aging Clin Exp Res. 2021 Oct;33(10):2797-2806. doi: 10.1007/s40520-021-01801-6. Epub 2021 Mar 8.

  PMID: 33686542 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Jonathan Myers
• Organization: VA Palo Alto Health Care System

Drj993@aol.com

6504503440

Study Officials

• Jonathan Neil Myers, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2013
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)