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Status unknownNCT02041156RENEXCUpdated Sep 23, 2016

Effects of Different Exercise Training Programs in CKD 4-5

An interventional study of aerobic and resistance training and aerobic combined with balance training in Chronic Kidney Disease, sponsored by Region Skane. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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]). 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.

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Conditions studied

  • Chronic Kidney Disease
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In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's planned enrollment of 150 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Region Skane is the lead sponsor of 382 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CKD 4 and 5
  • over 18 years of age
  • no neurological or orthopedic impairments
  • stable cardiac status

Exclusion criteria

Exclusion Criteria:

  • not on renal replacement therapy
  • no severe electrolyte disturbances
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    aerobic with resistance training

    Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity

    Other: aerobic and resistance training

  • Active comparator
    aerobic with balance training

    Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity

    Other: aerobic combined with balance training

Interventions

  • Otheraerobic and resistance training
  • Otheraerobic combined with balance training
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 4, 8 and 12 months

Secondary outcomes

  1. Cardiovascular morbidity

    Time frame: after 12 months

  2. Body composition

    Time frame: after 12 months

  3. Quality of Life

    Time frame: 4,8 and 12 months

  4. Inflammatory activity

    Time frame: 4, 8 and 12 months

  5. Bone density

    Time frame: 12 months

Other outcomes

  1. Compliance to exercise training protocol

    Time frame: 4, 8 and 12 month

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Study locations

1 of 1 sites recruiting
  • Skåne University Hospital
    Lund, 221 85, Sweden
    Recruiting
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References and documents

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 41083942 ↗
  • Denguir 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 39849350 ↗
  • Zhou 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 32571327 ↗
  • Zhou 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02041156
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Jan 20, 2014
Start date
Oct 2011
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Sep 23, 2016

Study contacts

Naomi Clyne, MD,PhD
Contact
Naomi.Clyne@med.lu.se
+4646 171682
Matthias Hellberg, MD
Contact
Matthias.Hellberg@skane.se
+4646175886
Naomi Clyne, MD, PhD
study director · Lund University
Matthias Hellberg, MD
principal investigator · Lund University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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