Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000196943
Ethics application status
Approved
Date submitted
26/10/2010
Date registered
18/02/2011
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a pre-transplant diet and exercise intervention on post-transplant metabolic profile in living kidney donor transplant recipients: the SIMPLICITY trial
Scientific title
In living kidney donor transplant recipients, does a pre-transplant intervention consisting of dietary advice and exercise improve post-transplant metabolic profile compared with usual pre-transplant care?
Secondary ID [1] 259637 0
Nil
Universal Trial Number (UTN)
Trial acronym
SIMPLICITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
New-onset diabetes after kidney transplantation 258456 0
Living donor kidney transplantation 258457 0
Condition category
Condition code
Metabolic and Endocrine 258618 258618 0 0
Diabetes
Renal and Urogenital 259352 259352 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 month intervention of dietary advice and exercise programme. Both components commence 3 months prior to transplantation and cease at the end of transplantation.

Dietary advice and behaviour modification will be prescribed by a qualified dietitian on an individual basis according to initial and subsequent assessments of disease profile, stage of kidney disease, body composition and medications. Dietary education will be based on meeting the Evidenced Based Guidelines for the Nutritional Management of Chronic Kidney Disease (2006).

The general objective behind each dietary prescription will be to increase muscle, reduce excess adipose tissue and stabilise biochemistry.

Advice will be given to the intervention group on a monthly basis for the first 3 months.

Dietary compliance will be measured by using a three day food dairy (using household measures) and during face-to-face visits with the dietitian. Two weekdays and one weekend day will be assessed at baseline, 1 week pre transplant and at 3 months post transplant. Additional records such as food diaries and logs may be used if clinically indicated.

Weight lifting (Progressive resistance training) exercises will be prescribed at baseline for each individual by the exercise trainer in accordance with baseline testing results and health status.

Each exercise session will include the following:
* Chest press
* Bent over single arm row
* Upright row
* Biceps curl
* Triceps kickback
* Leg extension
* Hip abduction
* Hamstring curls
* Abdominal lifts

Substitution of exercises will be done on an individual basis in accordance with injuries or conditions. The trainer will ensure at baseline that the study participants can successfully perform each exercise without supervision. Exercises will be performed at home with weights supplied by the hospital.
Duration/Intensity of Exercises.

Participants will perform 3 sets of 8 repetitions for each exercise listed above. During the first and second weeks, participants will achieve 50-60% (Borg Scale 10-13) of 1 repetition maximum. Participants will be advised to increase their training workload regularly, based on successful achievement of 3 sets of 12 repetitions at 2 consecutive sessions. An increase of approximately 5% training load would be recommended. Each session should last for 60 minutes and be undertaken on 3 occasions per week from 3 months pre transplantation.

At each exercise session participants will complete their perceived exertion on the Borg Scale and record training volumes, loads and adverse events in the training logs.

Participants will exercise independently throughout the study without supervision. Trainers will contact each participant on a weekly-fortnightly basis to offer motivation and assess their ongoing exercise program taking into consideration their returned exercise logs, health status and any reported adverse events.

At month 1 and 2 the intervention group will have a supervised exercise session with the trainer. These visits shall ensure compliance with the prescribed exercise regimen and exercise technique. Any modifications to the exercise regimen may be done at these visits such as increasing the load lifted. The trainer will ensure that the Borg Intensity Scale logs are being completed correctly. Additional supervised visits may be conducted at the trainer’s discretion, if the participant requires further training on the exercises.

At baseline, pre-transplantation and 3 months post transplant, participants will complete some basic fitness tests. A 3 repetition maximum strength test (93% of maximum lifting capacity) of their upper and lower body will be done to assess strength. The control group will also perform these fitness tests.
Intervention code [1] 257446 0
Lifestyle
Intervention code [2] 257489 0
Prevention
Comparator / control treatment
Usual pre-transplant care - no specific dietary or exercise programme.
Control group
Active

Outcomes
Primary outcome [1] 259510 0
Mean afternoon blood glucose, as measured by continuous glucose monitor
Timepoint [1] 259510 0
12pm - 6pm for the first six days post transplant
Primary outcome [2] 259511 0
Overall mean glucose, as measured by continuous glucose monitor
Timepoint [2] 259511 0
For the first six days post transplant
Primary outcome [3] 259512 0
Percentage excursion of glucose >11mmol/L
Timepoint [3] 259512 0
For the first six days post transplant
Secondary outcome [1] 266106 0
Glucose metabolic status and insulin resistance:
- oral glucose tolerance test with insulin levels
Timepoint [1] 266106 0
3 months post transplant
Secondary outcome [2] 266107 0
Change in glucose metabolic status from baseline to month 3
- oral glucose tolerance test with insulin levels
Timepoint [2] 266107 0
3 months post transplant
Secondary outcome [3] 266108 0
Change in cholesterol from baseline to 3 months post transplant
Timepoint [3] 266108 0
3 months post transplant
Secondary outcome [4] 273251 0
Change in body mass index from baseline to month 3
Timepoint [4] 273251 0
3 months post transplant
Secondary outcome [5] 273252 0
Change in waist circumference from baseline to month 3
Timepoint [5] 273252 0
3 months post transplant
Secondary outcome [6] 273253 0
Change in body composition from baseline to month 3. Body composition will be determined using Dual Energy X-ray Absorptiometry (DEXA).
Timepoint [6] 273253 0
3 months post transplant
Secondary outcome [7] 273254 0
Change in strength from baseline to month 3. A three repetition maximum strength test (93% of maximum lifting capacity) will be used to assess upper and lower body strength.
Timepoint [7] 273254 0
3 months post transplant
Secondary outcome [8] 273256 0
Change in diet from baseline to month 3. A 3 day food diary will be collected, and a qualified dietitian will review the diary and complete a nutritional assessment.
Timepoint [8] 273256 0
3 months post transplant
Secondary outcome [9] 273257 0
Prescribed regular use of any hypoglycaemic medication (yes/no), obtained via patient interview.
Timepoint [9] 273257 0
At discharge from hospital and 3 months post transplant

Eligibility
Key inclusion criteria
1. Recipients of living donor kidney transplant
2. 18 years or older at the time of enrolment
3. Diabetes excluded by pre-transplant oral glucose tolerance test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, NYHA class IV congestive heart failure)
2. Inability to give informed consent
3. Patient is pregnant or breastfeeding.
4. Current participation in another clinical trial
5. Patient is unlikely or unable to comply with the visits scheduled in the protocol (e.g. due to excessive travel requirements)
6. Insufficient comprehension to understand protocols or exercise safely

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will complete baseline measurements and then be randomised. The allocation will be concealed using numbered, sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by computer, using permuted blocks of varying size. Randomisation will be stratified by calcineurin inhibitor (tacrolimus or cyclosporin) which will be pre-specified prior to randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
8/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257935 0
Hospital
Name [1] 257935 0
Royal Prince Alfred Hospital
Country [1] 257935 0
Australia
Funding source category [2] 257936 0
Commercial sector/Industry
Name [2] 257936 0
Novartis Pharmaceuticals
Country [2] 257936 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Transplantation Services
Level 9, building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 257127 0
None
Name [1] 257127 0
Address [1] 257127 0
Country [1] 257127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259947 0
Sydney Local Health Network Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 259947 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 259947 0
Australia
Date submitted for ethics approval [1] 259947 0
27/10/2010
Approval date [1] 259947 0
24/02/2011
Ethics approval number [1] 259947 0
HREC/10/RPAH/544

Summary
Brief summary
This is a study to determine whether a 3 month program of diet and exercise can reduce the risk of diabetes following kidney transplantation from a living kidney donor
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31808 0
Prof Steve Chadban
Address 31808 0
Transplantation Services
Level 9, Building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 31808 0
Australia
Phone 31808 0
+61 2 9515 6600
Fax 31808 0
Email 31808 0
[email protected]
Contact person for public queries
Name 15055 0
Dr Philip Clayton
Address 15055 0
Department of Renal Medicine
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 15055 0
Australia
Phone 15055 0
+61295153438
Fax 15055 0
Email 15055 0
[email protected]
Contact person for scientific queries
Name 5983 0
Prof Steve Chadban
Address 5983 0
Transplantation Services
Level 9, Building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 5983 0
Australia
Phone 5983 0
+61295156600
Fax 5983 0
Email 5983 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.