Patients With Stage 2-4 Chronic Kidney DiseaseNCT01179906
Lifestyle Modifications and the Progression of Chronic Kidney Disease
A study testing Exercise training and Diet modification in people with Patients With Stage 2-4 Chronic Kidney Disease, run by Springfield College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Patients With Stage 2-4 Chronic Kidney Disease
- What is being tested?
- Exercise training and Diet modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2009
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stages 2-4 CKD
Who cannot join
- CAD
- MI
Trial locations and contacts
1 site in 1 country.
United States1 site
Springfield College
Springfield, Massachusetts, 01109
About this study
Official title: Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease
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.
- Being tested
- Exercise training, Diet modification
- Keywords
- CKD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Subjects exercise trained for 48 weeks with personal trainers at a college wellness center
Diet modificationBehavioural
Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention-exercise & diet | Experimental | Subjects trained for 48 weeks with a personal trainer Receives: Behavioral: Exercise training; Behavioral: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR)
GFR was estimated using the MDRD equation, creatinine clearance, urea clearance
Measured: 48 weeks
Secondary outcomes (1)
24 hour urine protein output
urine protein output is measured before and after 48 weeks of the training program
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Stage 2-4 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Springfield College
- Sponsor type
- University, hospital or other
- Collaborators
- Western New England Renal & Transplant Associates, PC
- Investigators
- Sam A Headley, Ph.D, Principal investigator, Springfield College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179906
- Sponsor's protocol ID
- BHS research incubator study
- Status last verified
- Jan 2006
- First submitted
- 10 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01179906
- Acronym / sponsor ID
- BHS research incubator study
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Springfield CollegeUniversity, hospital or other
- Collaborators
- Western New England Renal & Transplant Associates, PC
- Study start
- Jan 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Aug 2010 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention-exercise & diet | Experimental | Behavioral: Exercise training, Behavioral: Diet modificationSubjects trained for 48 weeks with a personal trainer |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stages 2-4 CKD
Key exclusion criteria (2 listed)
- CAD
- MI
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 trainingSubjects exercise trained for 48 weeks with personal trainers at a college wellness center | Behavioural | Lifestyle intervention-exercise & diet |
| Diet modificationExercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity | Behavioural | Lifestyle intervention-exercise & diet |
Primary outcome
Glomerular filtration rate (GFR)
Time frame: 48 weeks
GFR was estimated using the MDRD equation, creatinine clearance, urea clearance
1 secondary outcome
24 hour urine protein output
Time frame: 48 weeks
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 11 Aug 2010.
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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.
Sam A Headley, Ph.D principal investigator
Springfield 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 and Diet modification in people with Patients With Stage 2-4 Chronic Kidney Disease, 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 1 inclusion and 2 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 11 Aug 2010. 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?
Glomerular filtration rate (GFR) (time frame: 48 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 11 Aug 2010.