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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Samuel A. Headley, Springfield College
ClinicalTrials.gov Identifier:
NCT01399489
First received: January 31, 2011
Last updated: January 22, 2014
Last verified: January 2014

January 31, 2011
January 22, 2014
September 2009
December 2012   (final data collection date for primary outcome measure)
Change from Baseline in Arterial stiffness (pulse wave velocity) [ Time Frame: Change from Baseline in PWV at 16 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01399489 on ClinicalTrials.gov Archive Site
  • Change in Resting blood pressure from Baseline [ Time Frame: Baseline prior to acute exercise vs post acute exercise ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change in resting blood pressure from baseline at 16 weeks of training ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Aerobic Training and Arterial Stiffness in Chronic Kidney Disease (CKD) Patients
The Effect of Short-term Aerobic Training on Arterial Stiffness and Blood in Chronic Kidney Disease (CKD) Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Chronic Kidney Disease
  • Hypertension
  • Diabetes
Behavioral: Exercise training
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
Other Names:
  • Exercise Training
  • Non-pharmacologic
  • Lifestyle
  • Experimental: Exercise training
    Individuals randomized to this arm get 48 sessions of personal training in a state of the art fitness facility
    Intervention: Behavioral: Exercise training
  • No Intervention: Control
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01399489
1R15HL096097-01
No
Samuel A. Headley, Springfield College
Springfield College
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Samuel A Headley, Ph.D Sprtingfield College
Springfield College
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP