Lifestyle Modifications and the Progression of Chronic Ki... | NCT01179906

Studies
Lifestyle Modifications and the Progression of Chronic Kidney Disease

NCT01179906

Sponsor

Springfield College

Status

Completed

Last Update Posted

Aug 11, 2010Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Patients With Stage 2-4 Chronic Kidney Disease

Interventions

Exercise training
Diet modification

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Aug 10, 2010

First Submission Date that Met QC Criteria

Aug 10, 2010

First Posted Date

Aug 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2010

Last Update Posted Date

Aug 11, 2010Estimated

Name	Class
Western New England Renal & Transplant Associates, PC	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are:

To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care.
To explore possible mechanisms that could contribute to the observed changes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle intervention-exercise & diet	Experimental	Subjects trained for 48 weeks with a personal trainer	Behavioral: Exercise training Behavioral: Diet modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Behavioral	Subjects exercise trained for 48 weeks with personal trainers at a college wellness center	Lifestyle intervention-exercise & diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glomerular filtration rate (GFR)	GFR was estimated using the MDRD equation, creatinine clearance, urea clearance	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
24 hour urine protein output	urine protein output is measured before and after 48 weeks of the training program	48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stages 2-4 CKD

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam A Headley, Ph.D	Springfield College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Springfield College		Springfield	Massachusetts	01109	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D004035	Diet Therapy

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided