Effect of Exercise on Renal Function in Predialysis

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Active Comparator: Exercise; exercise intervention	Other: Exercise; 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.

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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: sharlene greenwood, Bsc, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; cardiovascular disease risk; kidney function
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: KCH11-123