Chronic Kidney DiseaseNCT01399489
Aerobic Training and Arterial Stiffness in Chronic Kidney Disease (CKD) Patients
A study testing Exercise training in people with Chronic Kidney Disease and Hypertension, run by Springfield College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension, Diabetes
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 3 Chronic Kidney Disease (CKD)
- Primary diagnosis hypertension or diabetes
Who cannot join
- Smokers
- Individuals < 35 or > 70 years of age
- Any contraindicators to exercise training as defined by the ACSM guidelines (GETP8)
Trial locations and contacts
1 site in 1 country.
United States1 site
Athletic Training and Exercise Science Building
Springfield, Massachusetts, 01109
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Hypertension, Diabetes
- Being tested
- Exercise training
- Keywords
- Aerobic exercise, Moderate intensity, Ambulatory blood pressure, Post exercise hypotension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Also called Non-pharmacologic, Lifestyle
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Individuals randomized to this arm get 48 sessions of personal training in a state of the art fitness facility Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in PWV at 16 weeks
Secondary outcomes (2)
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
Measured: Baseline prior to acute exercise vs post acute exercise
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
Measured: Change in resting blood pressure from baseline at 16 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Springfield College
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Samuel A. Headley, Springfield College
- Investigators
- Samuel A Headley, Ph.D, Principal investigator, Sprtingfield College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399489
- Sponsor's protocol ID
- 1R15HL096097-01
- Status last verified
- Jan 2014
- First submitted
- 31 Jan 2011
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Aerobic Training on Arterial Stiffness and Blood in Chronic Kidney Disease (CKD) Patients
- ClinicalTrials.gov ID
- NCT01399489
- Acronym / sponsor ID
- 1R15HL096097-01
- Conditions
- Chronic Kidney Disease, Hypertension, Diabetes
- Keywords
- Aerobic exercise, Moderate intensity, Ambulatory blood pressure, Post exercise hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Springfield CollegeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise trainingIndividuals randomized to this arm get 48 sessions of personal training in a state of the art fitness facility |
| 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 3 Chronic Kidney Disease (CKD)
- Primary diagnosis hypertension or diabetes
Key exclusion criteria (3 listed)
- Smokers
- Individuals < 35 or > 70 years of age
- Any contraindicators to exercise training as defined by the ACSM guidelines (GETP8)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAlso: Non-pharmacologic, LifestyleParticipants 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 | Behavioural | Exercise training |
Primary outcome
Change from Baseline in Arterial stiffness (pulse wave velocity)
Time frame: Change from Baseline in PWV at 16 weeks
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.
2 secondary outcomes
Change in Resting blood pressure from Baseline
Time frame: Baseline prior to acute exercise vs post acute exercise
Change in Resting blood pressure after 16 weeks of training
Time frame: Change in resting blood pressure from baseline at 16 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A Headley, Ph.D principal investigator
Sprtingfield College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Chronic Kidney Disease and Hypertension, run by Springfield College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Arterial stiffness (pulse wave velocity) (time frame: Change from Baseline in PWV at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.