None listed
Conditions
Brief summary
Chronic kidney disease (CKD) patients experience skeletal muscle wasting and this leads to decreased functional capacity and quality of life. A lifestyle intervention consisting of exercise and dietary advice is known to slow muscle wasting in older individuals however the effects in CKD patients is unknown. Furthermore, the mechanisms underlying these potential effects are not well understood. The aim of this study is to investigate the effects of an 8 week lifestyle intervention containing supervised exercise and dietary advice will effect markers of skeletal muscle structure and function in patients with chronic kidney disease. Patients will be recruited as part of the Landmark III study that is currently underway at the Princess Alexandra Hospital, Brisbane Australia. Following radomisation in to the larger study patients will be approached to participate in this sub study. 15 patients from each group will be recruited and undergo a muscle biopsy following baseline testing and then 12 weeks later. Muscle samples will be taken from the vastus lateralis muscle using the Bergstrom method and will be performed by a qualified medical practitioner. Muscle tissue samples will be stored in standard conditions, and analysis will be undertaken on completion of the sub study.
Interventions
Lifestyle intervention aimed at reducing cardiovascular risk in patients with Chronic Kidney Disease. The intervention will involve a supervised exercise program for a period of 8 weeks, in addition too dietary advice as well as access to other allied health providers as required. The patients will continue to receive ongoing support beyond the initial exercise and dietary components in line with the Landmark III protocol. The participants will attend the gym for a supervised exercise session by
Lifestyle intervention aimed at reducing cardiovascular risk in patients with Chronic Kidney Disease. The intervention will involve a supervised exercise program for a period of 8 weeks, in addition too dietary advice as well as access to other allied health providers as required. The patients will continue to receive ongoing support beyond the initial exercise and dietary components in line with the Landmark III protocol. The participants will attend the gym for a supervised exercise session by an accredited exercise physiologist, up to three times per week. Each session will last for approximately 60 minutes and will be of moderate intensity exercise. Participants will complete both aerobic and resistance exercise during each session, as well as stretching, warm up and cool down. The participants will undergo four group dietary and lifestyle sessions with a Dietician and Psychologist. The dietary and lifestyle sessions will assist the participants in identifying areas of their diet or lifestyle that may require change to assist the participants in achieving targets and improving their health. The group sessions will run during the eight week exercise period, with the participants attending one group session per week. Participants will undergo two muscle samples at baseline and 8 weeks. On completion of this initial assessment of muscle tissue, participants will continue as per the standard study protocol for the Landmark III study. Therefore the patient group receiving standard care will continue as per the study protocol and the group receiving the lifestyle intervention will continue to receive ongoing support.
Sponsors
A/Prof Jeff Coombes
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Stage 3 to 4 Kidney Disease (estimated Glomerular Filtration Rate <60ml/min and 25ml/min) - aged 18-75 years - at least one of the following risk factors - blood pressure not at target, Overweight (Body Mass Index >25); Poor diabetic control; or Lipids not at target
Exclusion criteria
- Unable or unwilling to give informed consent - eGFR<25ml/min - Pregnant - Life expectancy less than 6 months - Current involvement in other research study Organ transplant
Outcome results
None listed