NCT02155036
Completed
Phase 1
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.
King's College Hospital NHS Trust1 site in 1 country20 target enrollmentStarted: June 2011Last updated:
ConditionsChronic Kidney Disease
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- King's College Hospital NHS Trust
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- kidney function
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
kidney function
Time Frame: up to 12 months
estimated glomerular filtration rate (egfr) creatinine
Secondary Outcomes
- Body mass index (BMI)(Baseline, 6 and 12 months)
- Cardio-respiratory fitness testing (VO2peak)(Baseline, 6 and 12 months)
- Waist circumference(Baseline, 6 and 12 months)
- Duke's activity status index(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)
- Pulse Wave Velocity (arterial stiffness)(Baseline, 6 and 12 months)
- weight(Baseline, 6 and 12 months)
Investigators
Study Sites (1)
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