Effects of Different Exercise Training Programs in CKD 4-5 (RENEXC)
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
aerobic and resistance training
aerobic combined with balance training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
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
Sites / Locations
- Skåne University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aerobic with resistance training
aerobic with balance training
Arm Description
Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity
Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cardiovascular morbidity
Body composition
Quality of Life
Inflammatory activity
Bone density
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02041156
Brief Title
Effects of Different Exercise Training Programs in CKD 4-5
Acronym
RENEXC
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aerobic with resistance training
Arm Type
Experimental
Arm Description
Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity
Arm Title
aerobic with balance training
Arm Type
Active Comparator
Arm Description
Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity
Intervention Type
Other
Intervention Name(s)
aerobic and resistance training
Intervention Type
Other
Intervention Name(s)
aerobic combined with balance training
Primary Outcome Measure Information:
Title
Physical function
Description
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 Outcome Measure Information:
Title
Cardiovascular morbidity
Time Frame
after 12 months
Title
Body composition
Time Frame
after 12 months
Title
Quality of Life
Time Frame
4,8 and 12 months
Title
Inflammatory activity
Time Frame
4, 8 and 12 months
Title
Bone density
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Compliance to exercise training protocol
Time Frame
4, 8 and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Clyne, MD,PhD
Phone
+4646 171682
Email
Naomi.Clyne@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Hellberg, MD
Phone
+4646175886
Email
Matthias.Hellberg@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Clyne, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matthias Hellberg, MD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Hellberg, MD
Phone
+4646175886
Email
Matthias.Hellberg@skane.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
32571327
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.
Results Reference
derived
PubMed Identifier
31848626
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.
Results Reference
derived
Learn more about this trial
Effects of Different Exercise Training Programs in CKD 4-5
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