NCT02664519

Brief Summary

Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance. Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle blood flow regulation has not been fully explored. The investigators hypothesize that functional sympatholysis is exaggerated in CKD and this is associated with increased oxidative stress. The investigators also hypothesize that exercise training will improve functional sympatholysis and oxidative stress

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

5.2 years

First QC Date

January 8, 2016

Last Update Submit

March 19, 2021

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseFunctional sympatholysisExercise trainingExercise intoleranceHandgrip exerciseNear infrared spectroscopyLower body negative pressure

Outcome Measures

Primary Outcomes (1)

  • Change in muscle oxygenation

    Tissue oxygenation will be recorded using Near-infrared spectroscopy (NIRS)

    After 28 days

Secondary Outcomes (3)

  • Change in Forearm vascular conductance (FVC)

    After 28 days

  • Change in plasma isoprostanes

    After 28 days

  • Change in muscle sympathetic nerve activity (MSNA)

    After 28 days

Study Arms (3)

Exercise training followed by no exercise training

EXPERIMENTAL

CKD subjects will be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures.

Behavioral: Forearm exercise training

No exercise training followed by exercise training

EXPERIMENTAL

CKD subjects will be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. Procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures.

Behavioral: Forearm exercise training

Normal Control

NO INTERVENTION

Control subjects without CKD will undergo baseline assessment as above.

Interventions

Forearm exercise trainingBEHAVIORAL

Subjects will be asked to squeeze a tennis ball repeatedly for at least 30 min/day for 28 days at an approximate rate of 20 squeezes/min.

Exercise training followed by no exercise trainingNo exercise training followed by exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normotensive adults
  • CKD 2-3

You may not qualify if:

  • Blood Pressure ≥140/90
  • eGFR \>60ml/min/1.73 m2 or eGFR \<30ml/min/1.73 m2
  • Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography.
  • Diabetes mellitus or other systemic illness
  • Pregnancy
  • Any history of substance abuse or current cigarette use
  • Any history of psychiatric illness
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (10)

  • Moore GE, Painter PL, Brinker KR, Stray-Gundersen J, Mitchell JH. Cardiovascular response to submaximal stationary cycling during hemodialysis. Am J Kidney Dis. 1998 Apr;31(4):631-7. doi: 10.1053/ajkd.1998.v31.pm9531179.

    PMID: 9531179RESULT

  • Adams GR, Vaziri ND. Skeletal muscle dysfunction in chronic renal failure: effects of exercise. Am J Physiol Renal Physiol. 2006 Apr;290(4):F753-61. doi: 10.1152/ajprenal.00296.2005.

    PMID: 16527920RESULT

  • Paglialonga F, Lopopolo A, Scarfia RV, Galli MA, Consolo S, Brivio A, Grassi MR, Salera S, Edefonti A. Correlates of exercise capacity in pediatric patients on chronic hemodialysis. J Ren Nutr. 2013 Sep;23(5):380-6. doi: 10.1053/j.jrn.2013.04.006. Epub 2013 Jun 22.

    PMID: 23800461RESULT

  • Bradley JR, Anderson JR, Evans DB, Cowley AJ. Impaired nutritive skeletal muscle blood flow in patients with chronic renal failure. Clin Sci (Lond). 1990 Sep;79(3):239-45. doi: 10.1042/cs0790239.

    PMID: 2169372RESULT

  • Sakkas GK, Ball D, Mercer TH, Sargeant AJ, Tolfrey K, Naish PF. Atrophy of non-locomotor muscle in patients with end-stage renal failure. Nephrol Dial Transplant. 2003 Oct;18(10):2074-81. doi: 10.1093/ndt/gfg325.

    PMID: 13679483RESULT

  • Hansen J, Sander M, Thomas GD. Metabolic modulation of sympathetic vasoconstriction in exercising skeletal muscle. Acta Physiol Scand. 2000 Apr;168(4):489-503. doi: 10.1046/j.1365-201x.2000.00701.x.

    PMID: 10759586RESULT

  • Vongpatanasin W, Wang Z, Arbique D, Arbique G, Adams-Huet B, Mitchell JH, Victor RG, Thomas GD. Functional sympatholysis is impaired in hypertensive humans. J Physiol. 2011 Mar 1;589(Pt 5):1209-20. doi: 10.1113/jphysiol.2010.203026. Epub 2011 Jan 4.

    PMID: 21224235RESULT

  • Mizuno M, Iwamoto GA, Vongpatanasin W, Mitchell JH, Smith SA. Exercise training improves functional sympatholysis in spontaneously hypertensive rats through a nitric oxide-dependent mechanism. Am J Physiol Heart Circ Physiol. 2014 Jul 15;307(2):H242-51. doi: 10.1152/ajpheart.00103.2014. Epub 2014 May 9.

    PMID: 24816260RESULT

  • Piantadosi CA, Hemstreet TM, Jobsis-Vandervliet FF. Near-infrared spectrophotometric monitoring of oxygen distribution to intact brain and skeletal muscle tissues. Crit Care Med. 1986 Aug;14(8):698-706. doi: 10.1097/00003246-198608000-00007.

    PMID: 3013501RESULT

  • Kumar S, Seward J, Wilcox A, Torella F. Influence of muscle training on resting blood flow and forearm vessel diameter in patients with chronic renal failure. Br J Surg. 2010 Jun;97(6):835-8. doi: 10.1002/bjs.7004.

    PMID: 20309951RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wanpen Vongpatanasin, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 27, 2016

Study Start

January 1, 2016

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

US(1)