Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001169932
Ethics application status
Approved
Date submitted
2/11/2011
Date registered
9/11/2011
Date last updated
9/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Health Improved Through Training: a home based resistance training program for men with prostate cancer.
Scientific title
A pilot wait-list RCT to establish the feasability of a home based resistance training program for men with prostate cancer: the Get PHITT (Prostate Health Improved Through Training) Study
Secondary ID [1] 273311 0
Nil
Universal Trial Number (UTN)
U1111-1125-4705
Trial acronym
Get PHITT (Prostate Health Improved Through Training)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 279081 0
Muscular Strength 279082 0
Fatigue 279083 0
Quality of Life 279084 0
Condition category
Condition code
Cancer 279273 279273 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group is provided with: 1) a Gymstick (Trademark) (a lightweight graphite shaft, with elastic tubing and foot straps that provide resistance and can be used to exercise all of the major muscle groups) ; 2) a 12 week (3 sessions/wk for 30-40min each session) home-based resistance training program incorporating the Gymstick (Trademark), and; 3) A single 60-90min face-to-face consultation with an exercise specialist (at the commencement of the training program) who will demonstrate the exercises to the men and assist them with selection of their starting resistance levels for each exercise.
Intervention code [1] 283659 0
Treatment: Other
Intervention code [2] 283660 0
Lifestyle
Intervention code [3] 283661 0
Behaviour
Comparator / control treatment
No treatment wait-list control group. At the completion of the 12 week experimental phase, this group will have access to the same exercise program and equipment supplied to the experimental group should they desire.
Control group
Active

Outcomes
Primary outcome [1] 279892 0
Primary outcome: Muscular strength.

Muscular strength will be assessed using one-repetition maximum (1-RM) leg press test (American College of Sports Medicine (2006). ACSM's guidelines for exercise testing and prescription (7th ed.). USA: Lippincott Williams & Wilkins).
Timepoint [1] 279892 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [1] 294701 0
Secondary Outcome: Muscular Fitness.

Assessed by the 30 second chair stand test.
Timepoint [1] 294701 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [2] 294702 0
Secondary Outcome: Body composition.

Assessed by bioimpedance including fat mass, fat free mass and total body water. Body composition will be assessed by the InBody720 (Biospace Co., Ltd, Seoul, Korea).
Timepoint [2] 294702 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [3] 294703 0
Secondary Outcome: Measured height.
Timepoint [3] 294703 0
Timepoint: at baseline.
Secondary outcome [4] 294704 0
Secondary Outcome: Measured weight.
Timepoint [4] 294704 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [5] 294705 0
Secondary Outcome: Waist circumference.

Waist circumference will be measured at two points: (i) level with the umbilicus, and (ii) at the largest circumference between the lower costal border and the umbilicus.
Timepoint [5] 294705 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [6] 294706 0
Secondary Outcome: Lower body strength.

Assessed by the Chair Stand Test.
Timepoint [6] 294706 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [7] 294707 0
Secondary Outcome: Lower body flexibilty.

Assessed by the Chair Sit and Reach Test.
Timepoint [7] 294707 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [8] 294708 0
Secondary Outcome: Upper body flexibilty.

Assessed by the Back Scratch Test.
Timepoint [8] 294708 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [9] 294709 0
Secondary Outcome: Agility

Assessed by the 8-Foot Up and Go Test.
Timepoint [9] 294709 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [10] 294710 0
Secondary Outcome: Anxiety and depression.

Assessed using the Hospital Anxiety and Depression Scale (HADS).
Timepoint [10] 294710 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [11] 294711 0
Secondary Outcome: Quality of Life.

Assessed using the QLQ-C30 and SF-36.
Timepoint [11] 294711 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [12] 294712 0
Secondary Outcome: Fatigue.

Assessed using the FACT-fatigue.
Timepoint [12] 294712 0
Timepoint: at baseline and 3 months after randomisation.
Secondary outcome [13] 294713 0
Secondary Outcome: Physical Activity Cognitions.

Assessed via a patient reported survey including physical activity self efficacy, physical activity outcome expectation, physical activity social support, physical activity intention.
Timepoint [13] 294713 0
Timepoint: at baseline and 3 months after randomisation.

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age

Diagnosis of prostate cancer within the last 3 years (since 2008)

Cognitively and physically able to complete required tasks

English language ability sufficient to provide informed consent and complete survey items
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years of age

Cognitively and/or physically unable to complete required tasks

English language ability sufficient to provide informed consent and complete survey items

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)
Allocation involves contacting the holder of the allocation schedule who was "off-site" or at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control group.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4679 0
2300
Recruitment postcode(s) [2] 4680 0
2302
Recruitment postcode(s) [3] 4681 0
2291
Recruitment postcode(s) [4] 4682 0
2303
Recruitment postcode(s) [5] 4683 0
2293
Recruitment postcode(s) [6] 4684 0
2296
Recruitment postcode(s) [7] 4685 0
2294
Recruitment postcode(s) [8] 4686 0
2304
Recruitment postcode(s) [9] 4687 0
2295
Recruitment postcode(s) [10] 4688 0
2289
Recruitment postcode(s) [11] 4689 0
2292
Recruitment postcode(s) [12] 4690 0
2298
Recruitment postcode(s) [13] 4691 0
2304
Recruitment postcode(s) [14] 4692 0
2299
Recruitment postcode(s) [15] 4693 0
2305
Recruitment postcode(s) [16] 4694 0
2290
Recruitment postcode(s) [17] 4695 0
2306
Recruitment postcode(s) [18] 4696 0
2280
Recruitment postcode(s) [19] 4697 0
2282
Recruitment postcode(s) [20] 4698 0
2284
Recruitment postcode(s) [21] 4699 0
2285
Recruitment postcode(s) [22] 4700 0
2287
Recruitment postcode(s) [23] 4701 0
2307
Recruitment postcode(s) [24] 4702 0
2322
Recruitment postcode(s) [25] 4703 0
2323
Recruitment postcode(s) [26] 4704 0
2286
Recruitment postcode(s) [27] 4705 0
2278
Recruitment postcode(s) [28] 4706 0
2283
Recruitment postcode(s) [29] 4707 0
2264
Recruitment postcode(s) [30] 4708 0
2281
Recruitment postcode(s) [31] 4709 0
2262
Recruitment postcode(s) [32] 4710 0
2263
Recruitment postcode(s) [33] 4711 0
2259
Recruitment postcode(s) [34] 4712 0
2265
Recruitment postcode(s) [35] 4713 0
2318
Recruitment postcode(s) [36] 4714 0
2316
Recruitment postcode(s) [37] 4715 0
2319
Recruitment postcode(s) [38] 4716 0
2315
Recruitment postcode(s) [39] 4717 0
2317
Recruitment postcode(s) [40] 4718 0
2324
Recruitment postcode(s) [41] 4719 0
2267
Recruitment postcode(s) [42] 4720 0
2321

Funding & Sponsors
Funding source category [1] 284143 0
University
Name [1] 284143 0
University of Newcastle, Australia - Priority Research Centre for Health Behaviour
Country [1] 284143 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Erica James
Address
Level 3 David Maddison Building
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 269106 0
None
Name [1] 269106 0
Address [1] 269106 0
Country [1] 269106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272105 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 272105 0
Human Research Ethics Administration
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 272105 0
Australia
Date submitted for ethics approval [1] 272105 0
Approval date [1] 272105 0
14/09/2011
Ethics approval number [1] 272105 0
H20110243

Summary
Brief summary
Participation in physical activity (PA) helps relieve side effects of prostate cancer treatment, reduces depression and anxiety, enhances quality of life and importantly, improves prostate cancer (PCa)-specific survival. There are few existing exercise programs to promote and support behaviour change designed specifically for this cohort and the few available are generally not home-based or widely available. The intervention proposed here addresses these challenges in a cost-effective manner.
Trial website
Nil
Trial related presentations / publications
None to date.
Public notes

Contacts
Principal investigator
Name 33341 0
Address 33341 0
Country 33341 0
Phone 33341 0
Fax 33341 0
Email 33341 0
Contact person for public queries
Name 16588 0
Thomas Brookes
Address 16588 0
Discipline of Health Behaviour Sciences (HBS)
School of Medicine and Public Health
Level 3, David Maddison Building
Callaghan NSW 2308 Australia
Country 16588 0
Australia
Phone 16588 0
+61 2 49138640
Fax 16588 0
+61 2 49138601
Email 16588 0
[email protected]
Contact person for scientific queries
Name 7516 0
Associate Professor Erica James
Address 7516 0
Discipline of Health Behaviour Sciences (HBS)
School of Medicine and Public Health
Level 3, David Maddison Building
Callaghan NSW 2308 Australia
Country 7516 0
Australia
Phone 7516 0
+61 2 49138466
Fax 7516 0
+61 2 49138601
Email 7516 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.