Effects of Different Exercise Training Programs in CKD 4-5

NCT ID: NCT02041156

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2017-02-28

Brief 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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aerobic with resistance training

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

Group Type: EXPERIMENTAL

aerobic and resistance training

Intervention Type: OTHER

aerobic with balance training

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

Group Type: ACTIVE_COMPARATOR

aerobic combined with balance training

Intervention Type: OTHER

Interventions

aerobic and resistance training

Intervention Type: OTHER

aerobic combined with balance training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• not on renal replacement therapy
• no severe electrolyte disturbances

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Clyne, MD, PhD

Role: STUDY_DIRECTOR

Lund University

Matthias Hellberg, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Skåne University Hospital

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Naomi Clyne, MD,PhD

Role: CONTACT

Naomi.Clyne@med.lu.se

+4646 171682

Matthias Hellberg, MD

Role: CONTACT

Matthias.Hellberg@skane.se

+4646175886

Facility Contacts

Matthias Hellberg, MD

Role: primary

Matthias.Hellberg@skane.se

+4646175886

References

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.

Reference Type: DERIVED

PMID: 41083942 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39849350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32571327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31848626 (View on PubMed)

Other Identifiers

2011:369

Identifier Type: -

Identifier Source: org_study_id