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Aerobic Training and Arterial Stiffness in Chronic Kidney Disease (CKD) Patients

Primary Purpose

Chronic Kidney Disease, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Springfield College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Aerobic exercise, Moderate intensity, Ambulatory blood pressure, Post exercise hypotension

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage 3 Chronic Kidney Disease (CKD)
  • Primary diagnosis hypertension or diabetes

Exclusion Criteria:

  • Smokers
  • Individuals < 35 or > 70 years of age
  • Any contraindicators to exercise training as defined by the ACSM guidelines (GETP8)

Sites / Locations

  • Athletic Training and Exercise Science Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training

Control

Arm Description

Individuals randomized to this arm get 48 sessions of personal training in a state of the art fitness facility

Individuals in the control arm are expected to continue to live normally, following their doctor's advice but not engage in any formal exercise training.

Outcomes

Primary Outcome Measures

Change from Baseline in Arterial stiffness (pulse wave velocity)
Arterial stiffness is measured via pulse wave velocity. In addition augmentation index is also being assessed. Blood pressure is being measured under resting conditions and via 24 hr ambulatory devices.

Secondary Outcome Measures

Change in Resting blood pressure from Baseline
Resting blood pressure is measured at baseline before an acute bout of exercise and for 1 hour in the laboratory after 40 min of exercise. This is repeated after 16 weeks of training or after the 16 control period
Change in Resting blood pressure after 16 weeks of training
Resting blood pressure is measured at baseline before an acute bout of exercise and for 1 hour in the laboratory after 40 min of exercise. This is repeated after 16 weeks of training or after the 16 control period

Full Information

First Posted
January 31, 2011
Last Updated
January 22, 2014
Sponsor
Springfield College
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01399489
Brief Title
Aerobic Training and Arterial Stiffness in Chronic Kidney Disease (CKD) Patients
Official Title
The Effect of Short-term Aerobic Training on Arterial Stiffness and Blood in Chronic Kidney Disease (CKD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Springfield College
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study is designed to examine the impact of 16 weeks of moderate intensity aerobic training on arterial stiffness and blood pressure in stage 3 chronic kidney disease (CKD) patients. The investigators hypothesize that short term aerobic training will improve the stiffness of arteries in CKD patients.
Detailed Description
The focus of the current research group is to examine the impact of lifestyle interventions on the development of cardiovascular disease (CV) in chronic kidney disease (CKD) patients. The study being proposed is to determine the effect of short-term aerobic training on arterial stiffness and blood pressure (BP) in CKD patients. Arterial stiffness has been chosen as a dependent variable since it is one of the most important predictors of CV complications while hypertension is known to play a critical role both in the development of CV and in the progression of CKD (6, 41). The specific aims of the study are: (a) to determine the effect of short-term aerobic training on arterial stiffness in CKD patients, (b) to determine the effect of short-term aerobic training on resting and ambulatory blood pressures (ABP) in CKD patients and (c) to determine the effect of short-term aerobic training on the acute post-exercise blood pressure response in CKD patients since acute responses may be related to changes following a period of chronic training. Fifty, 35-70 yr old, stage 3 CKD patients, with either diabetes or hypertension as the primary cause of their CKD will be recruited for this study. Subjects will be randomly assigned to either the exercise group (ExG = 25) or to the control group (CG = 25). At the start of the study each subject will attend 4 research sessions. During the first session, resting and 24 hr ABP readings will be recorded. In the second session, anthropometric measures, peak oxygen uptake (VO2peak), and ABP values will be measured. Sessions 3 & 4 will be performed in random order. During these sessions, pulse wave velocity (PWV), augmentation index (AIx) and BP will be measured at baseline after a rest period. Subjects will then either walk for 30 min at 50-60% of VO2 peak, or sit quietly for an equal period of time. BP will be monitored for 60 min in recovery following exercise and ABP will be taken during the subsequent 24 hrs. ExG will perform supervised aerobic training for 45-50 min, 3 times per week, at a moderate intensity, for 16 weeks. CG will continue their activities of daily living but will not be given an exercise program. All subjects will be retested at week 8 for BP, ABP, and arterial stiffness and at week 16 for all variables. After 16 weeks of the study both groups will be retested using identical procedures as at baseline. A series of 2 X 2 analyses of covariance with age, baseline PWV, AIx and BP as the covariates, will be used to determine the effect of the 16 week intervention period on the primary outcome variables. A 2 X 7 X 2, mixed factorial repeated measures ANOVA will be used to analyze the post-exercise data while a Pearson Moment Correlation Coefficient will be computed to examine the relationship between post-exercise acute responses and BP changes following chronic training. An alpha level of 0.05 will be used for all analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension, Diabetes
Keywords
Aerobic exercise, Moderate intensity, Ambulatory blood pressure, Post exercise hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Individuals randomized to this arm get 48 sessions of personal training in a state of the art fitness facility
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals in the control arm are expected to continue to live normally, following their doctor's advice but not engage in any formal exercise training.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Non-pharmacologic, Lifestyle
Intervention Description
Participants receive 16 weeks of moderate intensity aerobic training under the supervision of personal trainers. Each session lasts from 15 to 55 minutes depending upon patient tolerance
Primary Outcome Measure Information:
Title
Change from Baseline in Arterial stiffness (pulse wave velocity)
Description
Arterial stiffness is measured via pulse wave velocity. In addition augmentation index is also being assessed. Blood pressure is being measured under resting conditions and via 24 hr ambulatory devices.
Time Frame
Change from Baseline in PWV at 16 weeks
Secondary Outcome Measure Information:
Title
Change in Resting blood pressure from Baseline
Description
Resting blood pressure is measured at baseline before an acute bout of exercise and for 1 hour in the laboratory after 40 min of exercise. This is repeated after 16 weeks of training or after the 16 control period
Time Frame
Baseline prior to acute exercise vs post acute exercise
Title
Change in Resting blood pressure after 16 weeks of training
Description
Resting blood pressure is measured at baseline before an acute bout of exercise and for 1 hour in the laboratory after 40 min of exercise. This is repeated after 16 weeks of training or after the 16 control period
Time Frame
Change in resting blood pressure from baseline at 16 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage 3 Chronic Kidney Disease (CKD) Primary diagnosis hypertension or diabetes Exclusion Criteria: Smokers Individuals < 35 or > 70 years of age Any contraindicators to exercise training as defined by the ACSM guidelines (GETP8)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel A Headley, Ph.D
Organizational Affiliation
Sprtingfield College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athletic Training and Exercise Science Building
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01109
Country
United States

12. IPD Sharing Statement

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Aerobic Training and Arterial Stiffness in Chronic Kidney Disease (CKD) Patients

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