Clinical trial NCT02041156: Effects of Different Exercise Training Programs in CKD 4-5
Official title: Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Physical function
timeFrame: 4, 8 and 12 months
Secondary outcomes:
measure: Cardiovascular morbidity
timeFrame: after 12 months
measure: Body composition
timeFrame: after 12 months
measure: Quality of Life
timeFrame: 4,8 and 12 months
measure: Inflammatory activity
timeFrame: 4, 8 and 12 months
measure: Bone density
timeFrame: 12 months
Other outcomes:
measure: Compliance to exercise training protocol
timeFrame: 4, 8 and 12 month
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Lund University
name: Naomi Clyne, MD, PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Matthias Hellberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.