Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000963325p
Ethics application status
Submitted, not yet approved
Date submitted
25/04/2017
Date registered
5/07/2017
Date last updated
5/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Let’s get active at North Ward Dialysis Unit, an exercise physiology led exercise program assessing the impact of exercise on dialysis function, Quality of Life, physical function and nutrition in a group of heamodialysis patients.
Scientific title
The impact of an exercise physiology led aerobic and resistance exercise program on dialysis efficiency, QoL, physical function, and nutrition status of people receiving haemodialysis: A prospective cohort study (pre / post study design).
Secondary ID [1] 292134 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis 303000 0
Condition category
Condition code
Renal and Urogenital 302463 302463 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to determine the impact of a progressive Accredited Exercise Physiologists (AEP) led resistance and aerobic training program on time to dialysis efficiency in haemodialysis patients as well as assess the impact of the intervention on nutritional status, body composition, physical function and quality of life.

Participants will perform a progressive exercise program at the satellite haemodialysis unit (pre dialysis and intra-dialysis exercises) for 17 weeks (i.e. 3 days / week for 17 weeks or until at least 180 minutes of physical activity per week has been achieved). The exercise will be led (in person) by an Accredited Exercise Physiologist with support from exercise physiology students. The pre dialysis exercise will be small group exercise sessions facilitated in person by an exercise physiologist. Tailored pre dialysis resistance training exercises will be prescribed for each patient to last 30 minutes including warm up and cool down. The program will target the major upper and lower body muscle groups, intensity will be progressively increased to ensure program progression and promote physiological adaptation. Intensity will be manipulated from the participant’s predicted Repetition Maximum (RM) or 60-75% of predicted RM, using 1-2 sets per exercise.

The intra-dialysis aerobic exercise sessions will include warm up, aerobic conditioning and cool down components using cycling on an arm/leg ergometer, as well as integrating basic body movements while seated to promote continuous aerobic exercise for a minimum of 30 minutes. The aerobic component of the intervention will commence within 1½ hours of starting HD treatment at an intensity of 55-70% of Heart Rate Maximum (HRmax), preferably above 60% HRmax, or a rating of 11-13 using the Borg Rating of Perceived exertion (RPE) scale.

Participants will work towards achieving 180 minutes of exercise / week.

The pre dialysis exercise will be small group exercise session led by an exercise physiologist. The on dialysis exercise will be individualised to each patients own capacity and facilitated in person by the exercise physiologist.

Patients will follow procedures, activities, and/or processes in accordance with their perceived capacity as directed by the exercise physiologist.
Intervention code [1] 298276 0
Treatment: Other
Comparator / control treatment
Prospective cohort study (pre / post study design). The outcome measures will be collected from participants before and after completion of the exercise program so that changes can be quantified.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301881 0
time on dialysis to achieve dialysis adequacy with the intervention. Dialysis adequacy will be assessed by pre and post dialysis change in urea. Urea is a middle molecular weight molecule that readily crosses the dialysis membrane and the clearance of this molecule from the blood during dialysis is the standard measure of dialysis efficacy.

Dialysis adequacy will be assessed by the single pool model of urea kinetics (spKt/V) and the urea reduction ratio (URR). the equation used to estimate urea clearance in this research project is the Jindal single pool model of urea kinetics (spKt/V). The spKt/V will be taken from the dialysis machine and the URR will be calculated by collecting pre and post dialysis urea pre intervention and once / month during the 4 month intervention taken on the say day as the routine monthly dialysis blood test.

The primary outcome will measure the effect of exercise on dialysis adequacy assessed by change in SpKt/V and URR.
Timepoint [1] 301881 0
The exercise intervention will run for 17 weeks. the primary outcome will be assessed at time zero and then monthly across the 17 week intervention (e.g. 5 times in total).
Secondary outcome [1] 334182 0
change in nutrition adequacy assessed by a 2 day food recall including one dialysis day and one non dialysis day, Food Frequency Questionnaire (FFQ) (Australian Eating Survey), and Patient Generated Subjective Global Assessment (PG-SGA).
Timepoint [1] 334182 0
time zero and at completion of the intervention (at 17 weeks)
Secondary outcome [2] 335816 0
change in body composition assessed using Dual-energy X-ray absorptiometry (DEXA);
Timepoint [2] 335816 0
time zero and at completion of the intervention (at 17 weeks)
Secondary outcome [3] 335817 0
change in physical function assessed by the short physical performance battery, box and block test, 6 minute walk test and 2 minute step test
Timepoint [3] 335817 0
time zero and at completion of the intervention (at 17 weeks)
Secondary outcome [4] 335818 0
change in QOL assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) and EuroQol five dimensions (EQ5D) questionnaire
Timepoint [4] 335818 0
time zero and at completion of the intervention (at 17 weeks)

Eligibility
Key inclusion criteria
All patients attending dialysis at NWHC (n=44) will be invited to participate. Inclusion criteria: (i) 18 years of age or older; (ii) on HD for >2 months; (iii) without acute or chronic medical conditions precluding participation assessed according to the relative and absolute contraindications to exercise developed by the American College of Sports Medicine (ACSM); (iv) adequately dialysed (Kt/v > 1.2); (v) stable during dialysis; (vi) cognition and English language adequate to understand the research and exercise protocols and provide written-informed consent; (vii) willingness to adhere to study protocols; and (vii) Nephrologist or GP medical clearance.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not medically cleared to undertake the exercise program, relative and absolute contraindications to exercise based on the American College of Sports Medicine (ACSM), refusal to participate, pregnant women and the human fetus, children and/ or young people (ie. <18 years) or people with severe cognitive impairment which would make participation potentially hazardous.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7890 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 15845 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 296279 0
Hospital
Name [1] 296279 0
Townsville Hospital Health Service Study, Education and Research Trust Account (SERTA)
Country [1] 296279 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital Health Service
Address
PO Box 670 Townsville
Internal Mail Box No 21
QLD 4810
Country
Australia
Secondary sponsor category [1] 295199 0
None
Name [1] 295199 0
Address [1] 295199 0
Country [1] 295199 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297511 0
Townsville Hospital Health Service Human Research Ethics Committee
Ethics committee address [1] 297511 0
Ethics committee country [1] 297511 0
Date submitted for ethics approval [1] 297511 0
27/03/2017
Approval date [1] 297511 0
Ethics approval number [1] 297511 0

Summary
Brief summary
This study aims to determine if participation in a progressive combined (resistance and aerobic) exercise program facilitated by Accredited Exercise Physiologists (AEPs) at dialysis is sufficient to show improvements in time to dialysis efficiency, nutritional adequacy, body composition, physical function, and quality of life (QOL).

The primary outcome is the time on dialysis to achieve dialysis adequacy with the intervention. This will be shown by improvements in SpKt/V and URR.

The secondary outcome measures include: 1) change in nutrition adequacy assessed by a 2 day food recall including one dialysis day and one non dialysis day, Food Frequency Questionnaire (FFQ) (Australian Eating Survey), and Patient Generated Subjective Global Assessment (PG-SGA); 2) change in body composition assessed using Dual-energy X-ray absorptiometry (DEXA); 3) change in physical function assessed by the short physical performance battery, box and block test, 6 minute walk test and 2 minute step test; 5) change in QOL assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) and EuroQol five dimensions (EQ5D) questionnaire

Research design: Prospective cohort study (pre / post study design).

This research project is designed for people on dialysis with low functional fitness. Participants must have a medical clearance prior to entering the program but once accepted will be encouraged to undertake an individualised exercise program during haemodialysis therapy. Conducting the exercise program during dialysis provides an opportunity for this population to be physically active at a time they are usually sedentary. Participants will perform a progressive exercise program at dialysis for 17 weeks (i.e. 3 days / week for 17 exercise sessions or until at least 180 minutes of physical activity per week has been achieved). The exercise will be led by an AEP with support from exercise physiology students. All outcome parameters for dialysis patients will be monitored as per usual care during the 17-week program. At completion, participants will be reassessed on the same tests as conducted at the beginning of the study so that pre-post comparisons can be made.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74278 0
Ms Katharine Clifford
Address 74278 0
The Townsville Hospital
PO Box 670
Townsville QLD
4810
Country 74278 0
Australia
Phone 74278 0
+61 7 44332950
Fax 74278 0
+61 7 44332371
Email 74278 0
[email protected]
Contact person for public queries
Name 74279 0
Ms Katharine Clifford
Address 74279 0
The Townsville Hospital
PO Box 670
Townsville QLD
4810
Country 74279 0
Australia
Phone 74279 0
+61 7 44332950
Fax 74279 0
+61 7 44332371
Email 74279 0
[email protected]
Contact person for scientific queries
Name 74280 0
Ms Katharine Clifford
Address 74280 0
The Townsville Hospital
PO Box 670
Townsville QLD
4810
Country 74280 0
Australia
Phone 74280 0
+61 7 44332950
Fax 74280 0
+61 7 44332371
Email 74280 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

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