Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000697280
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
12/08/2009
Date last updated
12/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A strengthening exercise program for chronic kidney disease (CKD) patients during haemodialysis: A pilot study
Scientific title
Effect of a strengthening exercise program on physical function and quality of life in chronic kidney disease (CKD) patients during haemodialysis: A pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease (CKD) 243406 0
Condition category
Condition code
Renal and Urogenital 239704 239704 0 0
Kidney disease
Musculoskeletal 239712 239712 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves participation in a group strengthening exercise program, following an individual physiotherapy assessment. The exercise sessions will be conducted on 2 days of the week, during haemodialysis sessions, for 16 weeks. The exercise sessions are conducted by a trained exercise leader, under the supervision of a physiotherapist, in the presence of ward nursing staff. Sessions are of approximately 45 minutes duration, and include a warm-up, progressive resistance training exercises for the 8 major muscle groups, and stretches/ cool-down. The resistance used includes body weight, dumbbells and resistance bands. Exercises are tailored to meet the needs of the individual, and progressed on an individual basis. Individuals are progressed via resistance used, number of repetitions and sets, and level of difficulty of the exercise. All patients receive usual routine nursing care, and this exercise program is in addition to that routine care.
Intervention code [1] 237033 0
Rehabilitation
Intervention code [2] 237034 0
Lifestyle
Comparator / control treatment
The control group will receive usual care only during their haemodialysis sessions for the 16 weeks of the study. Usual care includes access to informational brochures on physical activity and other health related topics. Patients are encouraged by nursing staff to have a healthy, active lifestyle. All patients receive usual routine nursing care.
Control group
Active

Outcomes
Primary outcome [1] 240473 0
physical functioning measured by 3m Timed Up and Go test, 30 second Chair Stand test, and Patient-Specific Functional Scale
Timepoint [1] 240473 0
baseline, 8 weeks, 16 weeks
Primary outcome [2] 240474 0
Mood and Quality of Life by GDS-5 (Alternate Geriatric Depression Scale) and EQ-5D (EuroQoL)
Timepoint [2] 240474 0
baseline, 8 weeks, 16 weeks
Secondary outcome [1] 257014 0
feasibility of introducing an exercise program into a haemodialysis unit measured by number of classes conducted over targeted time period and attendance rates
Timepoint [1] 257014 0
at 16 weeks after the commencement of exercise classes

Eligibility
Key inclusion criteria
over 18 years of age, on thrice weekly haemodialysis for at least 1 month before recruitment, able to perform chair-based exercise, able to participate in a group exercise situation, medical clearance obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
recent surgery, conditions where exercise is contraindicated, active infection.

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)
Informed consent will be sought from all patients of a haemodialysis unit who meet the inclusion criteria. Consenting patients who attend the haemodialysis unit on the three days Mondays, Wednesdays and Fridays will be allocated to the experimental group. Consenting patients who attend haemodialysis on the three days Tuesday, Thursday and Saturday will act as the control group. A randomised trial was considered but was not possible due to the difficulty and costs involved in employing an exercise supervisor on five weekdays and one weekend day for 4 months and the pilot nature of this trial.
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
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
1/07/2009
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)

Funding & Sponsors
Funding source category [1] 237423 0
Hospital
Name [1] 237423 0
Peninsula Health
Country [1] 237423 0
Australia
Primary sponsor type
Individual
Name
Caroline Stapleton
Address
The Gallery
Mt Eliza Centre, Peninsula Health
PO Box 192
Mt Eliza
Vic 3930
Country
Australia
Secondary sponsor category [1] 236916 0
Hospital
Name [1] 236916 0
Peninsula Health
Address [1] 236916 0
PO Box 52
Frankston
Vic 3199
Country [1] 236916 0
Australia
Other collaborator category [1] 795 0
Individual
Name [1] 795 0
Leonie Oldmeadow
Address [1] 795 0
The Gallery
Mt Eliza Centre, Peninsula Health
PO Box 192
Mt Eliza
Vic 3930
Country [1] 795 0
Australia
Other collaborator category [2] 796 0
Individual
Name [2] 796 0
Denise Pilkington
Address [2] 796 0
Haemodialysis Unit
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [2] 796 0
Australia
Other collaborator category [3] 797 0
Individual
Name [3] 797 0
Dean Gresle
Address [3] 797 0
Frankston Community Health
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [3] 797 0
Australia
Other collaborator category [4] 798 0
Individual
Name [4] 798 0
Anthea Hempel
Address [4] 798 0
Haemodialysis Unit
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [4] 798 0
Australia
Other collaborator category [5] 799 0
Individual
Name [5] 799 0
Heather Hinrichsen
Address [5] 799 0
Haemodialysis Unit
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [5] 799 0
Australia
Other collaborator category [6] 800 0
Individual
Name [6] 800 0
Dr Greg Perry
Address [6] 800 0
Haemodialysis Unit
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [6] 800 0
Australia
Other collaborator category [7] 801 0
Individual
Name [7] 801 0
Karen Edwards
Address [7] 801 0
Physiotherapy Dept
Frankston Hospital
Peninsula Health
PO Box 52
Frankston
Vic 3199
Country [7] 801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239548 0
Peninsula Health, Human Research and Ethics Committee
Ethics committee address [1] 239548 0
The Convenor,
Peninsula Health Research and Ethics Committee
The Gallery
Mt Eliza Centre, Peninsula Health
PO Box 192
Mt Eliza
Vic 3930
Ethics committee country [1] 239548 0
Australia
Date submitted for ethics approval [1] 239548 0
Approval date [1] 239548 0
14/04/2009
Ethics approval number [1] 239548 0
2009-13

Summary
Brief summary
This research project is aiming to investigate whether participating in a strengthening exercise program while receiving dialysis can help patients with chronic kidney disease to be physically fitter and generally feel better.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29983 0
Address 29983 0
Country 29983 0
Phone 29983 0
Fax 29983 0
Email 29983 0
Contact person for public queries
Name 13230 0
Caroline Stapleton
Address 13230 0
The Gallery, MEC
Peninsula Health
PO Box 192
Mt Eliza
Vic 3930
Country 13230 0
Australia
Phone 13230 0
+61 3 9788 1319
Fax 13230 0
Email 13230 0
cstapleton@phcn.vic.gov.au
Contact person for scientific queries
Name 4158 0
Caroline Stapleton
Address 4158 0
The Gallery, MEC
Peninsula Health
PO Box 192
Mt Eliza
Vic 3930
Country 4158 0
Australia
Phone 4158 0
+61 3 9788 1319
Fax 4158 0
Email 4158 0
cstapleton@phcn.vic.gov.au

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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