Effect of Exercise on Renal Function in Predialysis

Study Overview
=================
Brief Summary
-----------------
The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients; Preserves renal function. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.

Official Title
-----------------
The Effect of Exercise on Renal Function and Cardiovascular Disease in Pre-dialysis (Chronic Kidney Disease Stage 3-4) Patients With Chronic Kidney Disease; a Randomised Controlled Trial Pilot Study.

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

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min) Male or female Aged >18 years Written informed consent Exclusion Criteria: Pregnancy Requiring support for ambulation less than 20m Vasculitis, Proliferative diabetic retinopathy, Severe osteodystrophy, Uncontrolled diabetes, Psychiatric illness, including anxiety, mood and untreated eating disorders Infection or course of antibiotics within the last month

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 |
| --- | --- |
| No Intervention: Usual care<br>Usual care | |
| Active Comparator: Exercise<br>exercise intervention | Other: Exercise<br>* The intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE)  11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function | estimated glomerular filtration rate (egfr) creatinine | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-respiratory fitness testing (VO2peak) | cycle ergometer | Baseline, 6 and 12 months | 
| Pulse Wave Velocity (arterial stiffness) | Vicorder equipment, carotid-femoral region. | Baseline, 6 and 12 months | 
| Body mass index (BMI) |  | Baseline, 6 and 12 months | 
| weight |  | Baseline, 6 and 12 months | 
| Waist circumference |  | Baseline, 6 and 12 months | 
| Duke's activity status index | questionnaire | Baseline, 6 and 12 months | 
| Short Form 36 questionnaire |  | Baseline, 6 and 12 months | 
| Total cholesterol |  | Baseline, 6 and 12 months | 
| High sensitivity c-reactive protein (Hs CRP) |  | Baseline, 6 and 12 months | 
| Blood pressure |  | Baseline, 6 and 12 months | 
| Resting heart rate (HR) |  | Baseline, 6 and 12 months | 
| Triglycerides |  | baseline, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, rehabilitation, kidney function, cardiovascular disease risk