Skip to main content
OpenTrials
Completed

NCT Number: NCT02155036

Effect of Exercise on Renal Function in Predialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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 outcomes

  1. kidney function

    Time frame: up to 12 months

    estimated glomerular filtration rate (egfr) creatinine

Secondary outcomes

  1. Cardio-respiratory fitness testing (VO2peak)

    Time frame: Baseline, 6 and 12 months

    cycle ergometer

  2. Pulse Wave Velocity (arterial stiffness)

    Time frame: Baseline, 6 and 12 months

    Vicorder equipment, carotid-femoral region.

  3. Body mass index (BMI)

    Time frame: Baseline, 6 and 12 months

  4. weight

    Time frame: Baseline, 6 and 12 months

  5. Waist circumference

    Time frame: Baseline, 6 and 12 months

  6. Duke's activity status index

    Time frame: Baseline, 6 and 12 months

    questionnaire

  7. Short Form 36 questionnaire

    Time frame: Baseline, 6 and 12 months

  8. Total cholesterol

    Time frame: Baseline, 6 and 12 months

  9. High sensitivity c-reactive protein (Hs CRP)

    Time frame: Baseline, 6 and 12 months

  10. Blood pressure

    Time frame: Baseline, 6 and 12 months

  11. Resting heart rate (HR)

    Time frame: Baseline, 6 and 12 months

  12. Triglycerides

    Time frame: baseline, 6 and 12 months

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2014
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.