Clinical trial NCT02155036: Effect of Exercise on Renal Function in Predialysis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Keywords: exercise
rehabilitation
kidney function
cardiovascular disease risk
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 20
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 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;

1. Preserves renal function.
2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.


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

Primary outcomes:
measure: kidney function
timeFrame: up to 12 months
Secondary outcomes:
measure: Cardio-respiratory fitness testing (VO2peak)
timeFrame: Baseline, 6 and 12 months
measure: Pulse Wave Velocity (arterial stiffness)
timeFrame: Baseline, 6 and 12 months
measure: Body mass index (BMI)
timeFrame: Baseline, 6 and 12 months
measure: weight
timeFrame: Baseline, 6 and 12 months
measure: Waist circumference
timeFrame: Baseline, 6 and 12 months
measure: Duke's activity status index
timeFrame: Baseline, 6 and 12 months
measure: Short Form 36 questionnaire
timeFrame: Baseline, 6 and 12 months
measure: Total cholesterol
timeFrame: Baseline, 6 and 12 months
measure: High sensitivity c-reactive protein (Hs CRP)
timeFrame: Baseline, 6 and 12 months
measure: Blood pressure
timeFrame: Baseline, 6 and 12 months
measure: Resting heart rate (HR)
timeFrame: Baseline, 6 and 12 months
measure: Triglycerides
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: sharlene greenwood, Bsc
role: PRINCIPAL_INVESTIGATOR
References: