Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000944235
Ethics application status
Approved
Date submitted
17/09/2009
Date registered
3/11/2009
Date last updated
4/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a home-based exercise program during treatment on physiological and psychosocial outcomes in patients with lymphoma
Scientific title
The effects of a home-based exercise program versus standard care during treatment on physiological and psychosocial outcomes in adult patients with lymphoma.
Secondary ID [1] 251882 0
C.A.R.E. Program
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological malignancies 243865 0
Condition category
Condition code
Cancer 240038 240038 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 240039 240039 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 240040 240040 0 0
Myeloma
Cancer 257630 257630 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the exercise group will be required to complete three sessions per week of home-based physical activity for the duration of their treatment. Participants treatment duration will be determined by medical staff as treatment progresses, and is not altered by participation in this study. Prescription of the physical activity program will be implemented in accordance with the special precautions for cancer populations. Patients will be supervised for up to 3 weeks by an Exercise Physiologists to ensure correct exercise technique and intensity are achieved. Following this, patients will complete the final weeks of home-based physical activity on their own with reference to exercise booklets and DVDs, plus follow-up weekly phone calls and occasional visits during the intervention. A second group of participants will be placed on a waitlist and will complete the same home-based physical activity program following treatment.
Intervention code [1] 241303 0
Lifestyle
Comparator / control treatment
Active; waitlist group. Will commence the home-based program for 10 weeks, at 3 months post-treatment.
Control group
Active

Outcomes
Primary outcome [1] 240937 0
Body Composition assessed using Dual energy X-ray absorptiometry (DEXA).
Timepoint [1] 240937 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant. (Treatment duration for high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) is completely dependent upon the individual patients response to treatment. For example, if the patient responds well to chemotherapy, they may have a shorter duration of treatment compared to a patient who is slower to respond. Therefore specific 'weeks' of treatment cannot be given as it is variable. Follow-up testing for each patient will occur when they have a transplant and 3 months after that time.)
Primary outcome [2] 240938 0
Aerobic fitness will be assessed using an incremental exercise protocol on a cycle ergometer (Varberg, Sweden) used previously in a similar population (Courneya et al. 2003). Participants will perform continuous and incremental 2-minute workloads at 60 rpm until the criteria for peak oxygen consumption is reached. The initial power output of the exercise task will be 30 W and each subsequent power output will be increased by 15 W. Peak oxygen consumption will be determined by the highest minute value for oxygen recorded at the end of the test. Heart rate, ratings of perceived exertion (RPE) and blood pressure assessments will be obtained at the end of each workload.
Timepoint [2] 240938 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Primary outcome [3] 240939 0
Quality of life will be assessed using the Functional Assessment of Cancer Therapy General (FACT-G) scale, in addition to the SF-36.
Timepoint [3] 240939 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Primary outcome [4] 253142 0
All pertinent medical records will be obtained from the treating staff at Sir Charles Gairdner Hospital in order to obtain clinical measures of blood markers.
Timepoint [4] 253142 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Secondary outcome [1] 257659 0
Dynamic muscular strength is assessed by determining the weight for a 1 repetition maximum (RM) effort while doing a resistance exercise, however regression equations have been developed to estimate 1RM from a multiple repetition test making the testing safer for deconditioned participants. Participants will perform 10 repetitions of a given exercise lifting the heaviest weight they can whilst maintaining good exercise technique.
Timepoint [1] 257659 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Secondary outcome [2] 257660 0
International physical activity questionnaire
Timepoint [2] 257660 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Secondary outcome [3] 257661 0
The Symptom Assessment Scale (SAS) will be used to measure symptom distress in participants.
Timepoint [3] 257661 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.
Secondary outcome [4] 257662 0
The Schwartz cancer fatigue scale
Timepoint [4] 257662 0
At baseline, during treatment (time point to be determined by pilot testing), post-transplant and 3 months post-transplant.

Eligibility
Key inclusion criteria
Patients diagnosed with a haematological malignancy, scheduled for high-dose chemotherapy and autologous stem cell transplant, receive doctors consent,
able to provide written consent,
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) a pre-existing cardiac disease or uncontrolled hypertension
b) less than 18 years of age or older than 70
c) unable to participate in a 12 week structured exercise
d) unable to understand the implications of participation in the trial
e) currently engaged in a structured exercise programme
f) have undergone recent surgery which limits their ability to participate in exercise
g) do not pass the Revised Physical Activity Readiness Questionnaire (r-PARQ).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be computer randomised, controlled for age and gender, and allocated into the intervention or waitlist group. Allocation will be concealed by central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation will be performed by specific compter software. Stratified allocation by age and gender
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 243757 0
University
Name [1] 243757 0
University of Western Australia
Country [1] 243757 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Sport Science, Exercise and Health
M408, The University of Western Australia
35 Stirling Highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 237113 0
Charities/Societies/Foundations
Name [1] 237113 0
SolarisCare
Address [1] 237113 0
Ground Floor, Block E, 1 Hospital Avenue, NEDLANDS, WA 6009, Australia
Country [1] 237113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243886 0
Sir Charles Gairdner Hospital Ethics Committee
Ethics committee address [1] 243886 0
Ethics committee country [1] 243886 0
Australia
Date submitted for ethics approval [1] 243886 0
10/11/2009
Approval date [1] 243886 0
Ethics approval number [1] 243886 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30300 0
Address 30300 0
Country 30300 0
Phone 30300 0
Fax 30300 0
Email 30300 0
Contact person for public queries
Name 13547 0
Ashlee Joyce
Address 13547 0
School of Sport Science, Exercise and Health M408, The University of Western Australia 35 Stirling Highway, Crawley WA 6009
Country 13547 0
Australia
Phone 13547 0
+61 8 6488 1383
Fax 13547 0
Email 13547 0
[email protected]
Contact person for scientific queries
Name 4475 0
Ashlee Joyce
Address 4475 0
School of Sport Science, Exercise and Health M408, The University of Western Australia 35 Stirling Highway, Crawley WA 6009
Country 4475 0
Australia
Phone 4475 0
+61 8 6488 1383
Fax 4475 0
Email 4475 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
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