Effects of Different Exercise Training Programs in CKD 4-5

NCT02041156 | Unknown

• 1 other identifier: 2011:369
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  4, 8 and 12 months

Secondary Outcomes (5)

• Cardiovascular morbidity

  after 12 months

• Body composition

  after 12 months

• Quality of Life

  4,8 and 12 months

• Inflammatory activity

  4, 8 and 12 months

• Bone density

  12 months

Other Outcomes (1)

• Compliance to exercise training protocol

  4, 8 and 12 month

Study Arms (2)

aerobic with resistance training

EXPERIMENTAL

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

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

Other: aerobic combined with balance training

Interventions

aerobic and resistance training OTHER

aerobic with resistance training

aerobic combined with balance training OTHER

aerobic with balance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not on renal replacement therapy
• no severe electrolyte disturbances

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Lund, 221 85, Sweden

RECRUITING

Related Publications (4)

• 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.

  PMID: 41083942 DERIVED

• 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.

  PMID: 39849350 DERIVED

• 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.

  PMID: 32571327 DERIVED

• 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.

  PMID: 31848626 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Naomi Clyne, MD, PhD

  Lund University

  STUDY DIRECTOR

• Matthias Hellberg, MD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Clyne, MD,PhD

CONTACT

+4646 171682; Naomi.Clyne@med.lu.se

Matthias Hellberg, MD

CONTACT

+4646175886; Matthias.Hellberg@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 20, 2014
• Study Start: October 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

SE (1)