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Effect of Exercise on Renal Function in Predialysis

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring exercise, rehabilitation, kidney function, cardiovascular disease risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual care

Exercise

Arm Description

Usual care

exercise intervention

Outcomes

Primary Outcome Measures

kidney function
estimated glomerular filtration rate (egfr) creatinine

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2014
Last Updated
June 3, 2014
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02155036
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
exercise, rehabilitation, kidney function, cardiovascular disease risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sharlene greenwood, Bsc
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Exercise on Renal Function in Predialysis

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