Effects of Different Exercise Training Programs in CKD 4-5

Study Overview
=================
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.

Official Title
-----------------
Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: aerobic and resistance training
* Other: aerobic combined with balance training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic with resistance training<br>Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity | Other: aerobic and resistance training<br> <br> |
| Active Comparator: aerobic with balance training<br>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<br> <br> |

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 | Measure Description | 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 |