NCT01399489

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

January 31, 2011

Last Update Submit

January 22, 2014

Conditions

Keywords

Aerobic exerciseModerate intensityAmbulatory blood pressurePost exercise hypotension

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline in PWV at 16 weeks

Secondary Outcomes (2)

  • Change in Resting blood pressure from Baseline

    Baseline prior to acute exercise vs post acute exercise

  • Change in Resting blood pressure after 16 weeks of training

    Change in resting blood pressure from baseline at 16 weeks of training

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Behavioral: Exercise training

Control

NO INTERVENTION

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.

Interventions

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

Also known as: Non-pharmacologic, Lifestyle
Exercise training

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athletic Training and Exercise Science Building

Springfield, Massachusetts, 01109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertensionDiabetes MellitusPost-Exercise Hypotension

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 SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotension

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Samuel A Headley, Ph.D

    Sprtingfield College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 31, 2011

First Posted

July 21, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations