Effects of Different Exercise Training Programs in CKD 4-5 (RENEXC)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: aerobic and resistance training; Other: aerobic combined with balance training

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 221 85
    • Recruiting
    • Skane University Hospital
    • Contact: Matthias Hellberg, MD; Phone Number: +4646175886; Email: Matthias.Hellberg@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Compliance to exercise training protocol	4, 8 and 12 month

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Study Director: Naomi Clyne, MD, PhD, Lund University; Principal Investigator: Matthias Hellberg, MD, Lund University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2011:369