Chronic Kidney DiseasePhase 1/2NCT02155036
Effect of Exercise on Renal Function in Predialysis
A Phase 1/2 study testing Exercise in people with Chronic Kidney Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min)
- Male or female
- Aged >18 years
- Written informed consent
Who cannot join
- Pregnancy
- Requiring support for ambulation less than 20m
- Vasculitis,
- Proliferative diabetic retinopathy,
- Severe osteodystrophy,
- Uncontrolled diabetes,
- Psychiatric illness, including anxiety, mood and untreated eating disorders
- Infection or course of antibiotics within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise on Renal Function and Cardiovascular Disease in Pre-dialysis (Chronic Kidney Disease Stage 3-4) Patients With Chronic Kidney Disease; a Randomised Controlled Trial Pilot Study.
The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;
- Preserves renal function.
- Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.
- Conditions
- Chronic Kidney Disease
- Being tested
- Exercise
- Keywords
- exercise, rehabilitation, kidney function, cardiovascular disease risk
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE) ~11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care |
| Exercise | Active comparator | exercise intervention Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney function
estimated glomerular filtration rate (egfr) creatinine
Measured: up to 12 months
Secondary outcomes (12)
Cardio-respiratory fitness testing (VO2peak)
cycle ergometer
Measured: Baseline, 6 and 12 months
Pulse Wave Velocity (arterial stiffness)
Vicorder equipment, carotid-femoral region.
Measured: Baseline, 6 and 12 months
Body mass index (BMI)
Measured: Baseline, 6 and 12 months
weight
Measured: Baseline, 6 and 12 months
Waist circumference
Measured: Baseline, 6 and 12 months
Duke's activity status index
questionnaire
Measured: Baseline, 6 and 12 months
Short Form 36 questionnaire
Measured: Baseline, 6 and 12 months
Total cholesterol
Measured: Baseline, 6 and 12 months
High sensitivity c-reactive protein (Hs CRP)
Measured: Baseline, 6 and 12 months
Blood pressure
Measured: Baseline, 6 and 12 months
Resting heart rate (HR)
Measured: Baseline, 6 and 12 months
Triglycerides
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sharlene greenwood, Bsc, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155036
- Sponsor's protocol ID
- KCH11-123
- Status last verified
- Jun 2014
- First submitted
- 27 May 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Renal Function and Cardiovascular Disease in Pre-dialysis (Chronic Kidney Disease Stage 3-4) Patients With Chronic Kidney Disease; a Randomised Controlled Trial Pilot Study.
- ClinicalTrials.gov ID
- NCT02155036
- Acronym / sponsor ID
- KCH11-123
- Conditions
- Chronic Kidney Disease
- Keywords
- exercise, rehabilitation, kidney function, cardiovascular disease risk
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Jun 2014 (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 proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;
- Preserves renal function.
- Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care |
| Exercise | Active comparator | Other: Exerciseexercise intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min)
- Male or female
- Aged >18 years
- Written informed consent
Key exclusion criteria (8 listed)
- Pregnancy
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 |
|---|---|---|
| ExerciseThe intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE) ~11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly. | Other | Exercise |
Primary outcome
kidney function
Time frame: up to 12 months
estimated glomerular filtration rate (egfr) creatinine
12 secondary outcomes
Cardio-respiratory fitness testing (VO2peak)
Time frame: Baseline, 6 and 12 months
Pulse Wave Velocity (arterial stiffness)
Time frame: Baseline, 6 and 12 months
Body mass index (BMI)
Time frame: Baseline, 6 and 12 months
weight
Time frame: Baseline, 6 and 12 months
Waist circumference
Time frame: Baseline, 6 and 12 months
Duke's activity status index
Time frame: Baseline, 6 and 12 months
Short Form 36 questionnaire
Time frame: Baseline, 6 and 12 months
Total cholesterol
Time frame: Baseline, 6 and 12 months
High sensitivity c-reactive protein (Hs CRP)
Time frame: Baseline, 6 and 12 months
Blood pressure
Time frame: Baseline, 6 and 12 months
Resting heart rate (HR)
Time frame: Baseline, 6 and 12 months
Triglycerides
Time frame: baseline, 6 and 12 months
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 4 Jun 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.
sharlene greenwood, Bsc principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise in people with Chronic Kidney Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 8 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 4 Jun 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 Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
kidney function (time frame: up to 12 months). 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 4 Jun 2014.