NCT01036490

Brief Summary

Patients with type 2 diabetes, obesity, and chronic kidney disease are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. This study seeks to determine if a structured exercise program will benefit the heart (improved exercise tolerance, decreased blood pressure) and/or the kidney (decreased protein loss in urine and stabilization of kidney function) and lead to improvements in diabetes, body composition, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 27, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

4.5 years

First QC Date

December 17, 2009

Results QC Date

March 24, 2016

Last Update Submit

June 6, 2018

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • Change in Proteinuria

    12 weeks minus baseline

  • Change in Proteinuria

    52 weeks minus baseline

Secondary Outcomes (4)

  • Change in Albuminuria

    12 weeks minus baseline

  • Change in Albuminuria

    52 weeks minus baseline

  • Change in Estimated Glomerular Filtration Rate (eGFR)

    12 weeks minus baseline

  • Change in Estimated Glomerular Filtration Rate (eGFR)

    52 weeks minus baseline

Study Arms (2)

Control

NO INTERVENTION

Control group

Exercise

EXPERIMENTAL

Exercise Group

Other: Exercise

Interventions

ExerciseOTHER

Exercise training for 12 weeks followed by home exercise for 40 weeks

Exercise

Eligibility Criteria

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

You may qualify if:

  • Diabetes mellitus
  • CKD Stages 2-4
  • BMI \> 30
  • Persistent proteinuria (urine protein/creatinine \> 200 mg/g for \> 3 mo)
  • On treatment with ACE inhibitor or ARB
  • On treatment with aspirin
  • On treatment with statin (if LDL \> 100)

You may not qualify if:

  • Symptomatic neuropathy/retinopathy
  • Positive stress test due to coronary arterial disease
  • Symptomatic cardiovascular disease
  • Congestive heart failure (New York Heart Association Class III or IV)
  • Chronic obstructive pulmonary disease (FEV1 \< 50% predicted and/or requires supplemental oxygen support during exercise)
  • Complaints of angina during the stress test
  • Cerebrovascular disease/cognitive impairment
  • Renal transplant
  • Inability to walk on the treadmill
  • Any unforeseen illness or disability that would preclude exercise testing or training
  • Participation in a formal exercise program within the previous 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Related Publications (1)

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

    PMID: 33782940DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Due to inability to reach our expected target randomization (30 per group), our study may be underpowered to detect differences between the groups.

Results Point of Contact

Title
David J. Leehey, M.D.
Organization
Hines VA Hospiral
david.leehey@va.gov
(708)2022589

Study Officials

  • David J Leehey

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

  • Eileen G. Collins, PhD RN

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 17, 2009

First Posted

December 21, 2009

Study Start

July 1, 2010

Primary Completion

December 31, 2014

Study Completion

June 30, 2017

Last Updated

July 6, 2018

Results First Posted

April 27, 2016

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)