Effect of Exercise on Renal Function in Predialysis

Chronic Kidney Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155036
• Other study ID #: KCH11-123
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 27, 2014
• Last updated: June 3, 2014
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: The UK ethics committee authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney function	estimated glomerular filtration rate (egfr) creatinine	up to 12 months	No
Secondary	Cardio-respiratory fitness testing (VO2peak)	cycle ergometer	Baseline, 6 and 12 months	No
Secondary	Pulse Wave Velocity (arterial stiffness)	Vicorder equipment, carotid-femoral region.	Baseline, 6 and 12 months	No
Secondary	Body mass index (BMI)		Baseline, 6 and 12 months	No
Secondary	weight		Baseline, 6 and 12 months	No
Secondary	Waist circumference		Baseline, 6 and 12 months	No
Secondary	Duke's activity status index	questionnaire	Baseline, 6 and 12 months	No
Secondary	Short Form 36 questionnaire		Baseline, 6 and 12 months	No
Secondary	Total cholesterol		Baseline, 6 and 12 months	No
Secondary	High sensitivity c-reactive protein (Hs CRP)		Baseline, 6 and 12 months	No
Secondary	Blood pressure		Baseline, 6 and 12 months	No
Secondary	Resting heart rate (HR)		Baseline, 6 and 12 months	No
Secondary	Triglycerides		baseline, 6 and 12 months	No