Chronic Kidney DiseaseRENEXCNCT02041156
Effects of Different Exercise Training Programs in CKD 4-5
A study testing aerobic and resistance training and aerobic combined with balance training in people with Chronic Kidney Disease, run by Region Skane at 1 site in Sweden.
Trial summary
The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). 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?
- aerobic and resistance training and aerobic combined with balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD 4 and 5
- over 18 years of age
- no neurological or orthopedic impairments
- stable cardiac status
Who cannot join
- not on renal replacement therapy
- no severe electrolyte disturbances
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, 221 85
Matthias Hellberg, MD, +4646175886, Matthias.Hellberg@skane.se
About this study
Official title: Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study
The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.
- Conditions
- Chronic Kidney Disease
- Being tested
- aerobic and resistance training, aerobic combined with balance training
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic and resistance trainingOther
aerobic combined with balance trainingOther
| Study group | Role | What they receive |
|---|---|---|
| aerobic with resistance training | Experimental | Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity Receives: Other: aerobic and resistance training |
| aerobic with balance training | Active comparator | Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity Receives: Other: aerobic combined with balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
6 minutes walking test, 30 seconds sit to stand, stair climbing, handgrip strength, Isometric quadriceps strength, functional reach, standing heel rise, toes lift, picking-up test, Berg balance scale
Measured: 4, 8 and 12 months
Secondary outcomes (5)
Cardiovascular morbidity
Measured: after 12 months
Body composition
Measured: after 12 months
Quality of Life
Measured: 4,8 and 12 months
Inflammatory activity
Measured: 4, 8 and 12 months
Bone density
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startOct 2011
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Clyne, MD, PhD, Study director, Lund UniversityMatthias Hellberg, MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041156
- Sponsor's protocol ID
- 2011:369
- Acronym
- RENEXC
- Status last verified
- Sep 2016
- First submitted
- 7 Jan 2014
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Petrauskiene V, Hellberg M, Svensson P, Clyne N. Markers of bone turnover after 12 months of exercise in patients with chronic kidney disease 3-5: a post-hoc analysis of RENEXC - a randomized controlled trial. BMC Nephrol. 2025 Oct 13;26(1):561. doi: 10.1186/s12882-025-04501-9.
PubMed 41083942Denguir S, Hellberg M, Almquist M, Clyne N. Survival in patients with CKD 3-5 after 12 months of exercise training - a post-hoc analysis of the RENEXC trial. BMC Nephrol. 2025 Jan 23;26(1):36. doi: 10.1186/s12882-024-03915-1.
PubMed 39849350Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Twelve months of exercise training did not halt abdominal aortic calcification in patients with CKD - a sub-study of RENEXC-a randomized controlled trial. BMC Nephrol. 2020 Jun 22;21(1):233. doi: 10.1186/s12882-020-01881-y.
PubMed 32571327Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Muscle mass and plasma myostatin after exercise training: a substudy of Renal Exercise (RENEXC)-a randomized controlled trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):95-103. doi: 10.1093/ndt/gfz210.
PubMed 31848626
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study
- ClinicalTrials.gov ID
- NCT02041156
- Acronym / sponsor ID
- RENEXC / 2011:369
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 20 Jan 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 investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic with resistance training | Experimental | Other: aerobic and resistance trainingRegular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity |
| aerobic with balance training | Active comparator | Other: aerobic combined with balance trainingRegular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD 4 and 5
- over 18 years of age
- no neurological or orthopedic impairments
- stable cardiac status
Key exclusion criteria (2 listed)
- not on renal replacement therapy
- no severe electrolyte disturbances
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 |
|---|---|---|
| aerobic and resistance training | Other | aerobic with resistance training |
| aerobic combined with balance training | Other | aerobic with balance training |
Primary outcome
Physical function
Time frame: 4, 8 and 12 months
6 minutes walking test, 30 seconds sit to stand, stair climbing, handgrip strength, Isometric quadriceps strength, functional reach, standing heel rise, toes lift, picking-up test, Berg balance scale
5 secondary outcomes
Cardiovascular morbidity
Time frame: after 12 months
Body composition
Time frame: after 12 months
Quality of Life
Time frame: 4,8 and 12 months
Inflammatory activity
Time frame: 4, 8 and 12 months
Bone density
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Derived from this study: PubMed 41083942Petrauskiene V, Hellberg M, Svensson P, Clyne N. Markers of bone turnover after 12 months of exercise in patients with chronic kidney disease 3-5: a post-hoc analysis of RENEXC - a randomized controlled trial. BMC Nephrol. 2025 Oct 13;26(1):561. doi: 10.1186/s12882-025-04501-9.
- Derived from this study: PubMed 39849350Denguir S, Hellberg M, Almquist M, Clyne N. Survival in patients with CKD 3-5 after 12 months of exercise training - a post-hoc analysis of the RENEXC trial. BMC Nephrol. 2025 Jan 23;26(1):36. doi: 10.1186/s12882-024-03915-1.
- Derived from this study: PubMed 32571327Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Twelve months of exercise training did not halt abdominal aortic calcification in patients with CKD - a sub-study of RENEXC-a randomized controlled trial. BMC Nephrol. 2020 Jun 22;21(1):233. doi: 10.1186/s12882-020-01881-y.
- Derived from this study: PubMed 31848626Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Muscle mass and plasma myostatin after exercise training: a substudy of Renal Exercise (RENEXC)-a randomized controlled trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):95-103. doi: 10.1093/ndt/gfz210.
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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.
Naomi Clyne, MD, PhD study director
Lund University
Matthias Hellberg, MD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic and resistance training and aerobic combined with balance training in people with Chronic Kidney Disease, run by Region Skane at 1 site in Sweden.
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 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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Clyne, MD,PhD (+4646 171682, Naomi.Clyne@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: 4, 8 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041156, which also lists 4 linked publications.
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 Sep 2016.