Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000690853
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
7/06/2021
Date last updated
25/11/2022
Date data sharing statement initially provided
7/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of eccentric overload resistance exercise training on muscle mass and strength for people with prostate cancer and chemical castration
Scientific title
The effects of accentuated eccentric resistance training on muscle mass and strength in prostate cancer patients undergoing androgen-deprivation therapy
Secondary ID [1] 303756 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 321237 0
Lean muscle mass decline 321238 0
Condition category
Condition code
Cancer 319026 319026 0 0
Prostate
Musculoskeletal 319493 319493 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will undergo 36 sessions of an accentuated eccentric resistance exercise training protocol planned for 3 × week for approximately 12 weeks. However, this will be tailored to the physical capacity of the participant, so the duration may be prolonged to 18 weeks in order for 36 sessions to be completed if the participant is only capable of performing 2 sessions per week.

The participants will perform circuits of 6 exercises (in their order of execution: abdominal crunch, seated row, chest press, lat pulldown, shoulder press, and leg press) using servomotor-driven resistance exercise machines (BioCircuit, TechnoGym, Italy). Before each training session, the participants will warm up by performing a circuit of 6 repetitions in each machine using ~50% of their prescribed resistance for the session.

The intensity of the concentric phase will be 40–80% of 1 repetition maximum (maximum weight that can be lifted with one repetition) while the eccentric phase will be 125% of the concentric load. Both the intensity and number of repetitions will vary during the trial. The repetitions will be split into 3 circuits. The time the participant takes to walk from one exercise station to another and assume the correct position will be used as an active rest period between exercises.

The resistance training sessions will be at least 48 h apart for each participant to allow for adequate recovery. All sessions will be conducted in small groups of one to five participants under direct supervision by exercise scientists to ensure safety and appropriate exercise technique.

A serving of 30 g of whey protein concentrate (Bulk Nutrients, Australia), containing 22.3 g of protein, 1.9 g of fat, and 2.8 g of carbohydrates, will be dissolved in 300 ml of water and given to the participants at the end of each exercise session. The participants will be asked to consume the drink in front of the investigator prior to leaving the facility. All participants will be informed about the allergens of the product (milk, soy, soybean, whey) prior to participation in the study.

Adherence to the exercise protocol will be assessed via assessing the adherence to the sessions (the ratio of the total number of training sessions attended to the number scheduled), while dosage will be assessed via calculating the volume prescribed vs performed (sets × repetition × weight(kg).

Whey protein will be asked to be consumed after each exercise session in the presence of the investigator, and the dosage will be 30 g (single serve) that will be given to the participant pre-mixed with water by the investigator.
Intervention code [1] 320073 0
Lifestyle
Intervention code [2] 320418 0
Treatment: Other
Comparator / control treatment
Pre- versus post-intervention, no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326928 0
Whole-body lean mass (assessed through dual energy X-ray absorptiometry)
Timepoint [1] 326928 0
1. Baseline
2. 4 days post-intervention completion
Primary outcome [2] 326929 0
Muscle strength (Composite; maximum strength test for each exercise that will be performed during the training: abdominal crunch, seated row, chest press, lat pulldown, shoulder press, and leg press)
Timepoint [2] 326929 0
1. Baseline
2. 4 days post-intervention completion
Primary outcome [3] 326930 0
Knee extensor muscle area (composite; assessed through ultrasonography)
Timepoint [3] 326930 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [1] 393157 0
Mid-thigh muscle area (through peripheral quantitative tomography)
Timepoint [1] 393157 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [2] 393158 0
Postural balance (composite; assessed through NeuroCom Smart Balance Master, Natus Medical, USA).
Timepoint [2] 393158 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
5. 4 days post-intervention completion
Secondary outcome [3] 393159 0
Safety of the intervention (participant-reported adverse events)
Timepoint [3] 393159 0
Any adverse events throughout the intervention will be reported (from the first familiarization session until 72 h after the post-training testing session.
Secondary outcome [4] 393160 0
Exercise dosage (sets × repetition × weight(kg)) recorded by the exercise scientist.
Timepoint [4] 393160 0
Dosage will be calculated after every training session (36 in total). Exercise dosage will be recorded by the exercise scientist during each session
Secondary outcome [5] 393161 0
Muscle soreness (via a 0-100 mm VAS scale)
Timepoint [5] 393161 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [6] 393162 0
Health-related quality of life (Functional Assessment of Cancer Therapy – Prostate, Version 4 (FACT-P))
Timepoint [6] 393162 0
1. Baseline
2. Post-intervention
Secondary outcome [7] 394745 0
Adherence to the intervention. Adherence will be calculated per participant by the ratio of the total number of training sessions attended to the number scheduled at the conclusion of the study, and reported cumulatively for all participants.
Timepoint [7] 394745 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [8] 394746 0
Perception of fatigue (Functional Assessment of Chronic Illness Therapy – Fatigue, Version 4 (FACIT-F)
Timepoint [8] 394746 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [9] 396107 0
Whole-body fat mass (primary outcome; assessed through dual energy X-ray absorptiometry)
Timepoint [9] 396107 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [10] 396108 0
Whole-body bone mineral density, (primary outcome; assessed through dual energy X-ray absorptiometry)
Timepoint [10] 396108 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [11] 396109 0
Mid-thigh fat area ( through peripheral quantitative tomography)
Timepoint [11] 396109 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [12] 396110 0
Tumor necrosis factor a blood levels
Timepoint [12] 396110 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [13] 396111 0
C-reactive protein blood levels
Timepoint [13] 396111 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [14] 396112 0
interleukin 6 blood levels
Timepoint [14] 396112 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [15] 396113 0
Low-density lipoprotein blood levels
Timepoint [15] 396113 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [16] 396114 0
High-density lipoprotein blood levels
Timepoint [16] 396114 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [17] 396115 0
tryglycerides blood levels
Timepoint [17] 396115 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [18] 396116 0
cholesterol blood levels
Timepoint [18] 396116 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [19] 396117 0
fructosamine blood levels
Timepoint [19] 396117 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [20] 396118 0
creatine kinase blood levels
Timepoint [20] 396118 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [21] 396119 0
insulin growth factor-1 blood levels
Timepoint [21] 396119 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [22] 396120 0
growth hormone blood levels
Timepoint [22] 396120 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [23] 396121 0
dehydroepiandrosterone blood levels
Timepoint [23] 396121 0
1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
Secondary outcome [24] 396122 0
Testosterone blood levels
Timepoint [24] 396122 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [25] 396124 0
Prostate Specific Antigen blood levels
Timepoint [25] 396124 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [26] 396125 0
400 m walk time (time to complete 400 meters walk) timed using a digital stopwatch
Timepoint [26] 396125 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [27] 396126 0
30 second sit to stand test (how many times they can sit and stand from a chair in 30 seconds)
Timepoint [27] 396126 0
1. Baseline
2. 4 days post-intervention completion
Secondary outcome [28] 396127 0
Stair descend test (how fast they can descend 15 steps)
Timepoint [28] 396127 0
1. Baseline
2. 4 days post-intervention completion

Eligibility
Key inclusion criteria
Men with prostate cancer undergoing androgen deprivation therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include absence of histologically documented prostate cancer; having undergone chemotherapy within the previous 6 months; not receiving ADT in the previous 3 months; not scheduled to receive ADT for the subsequent 4 months; any metastatic disease; any musculoskeletal, cardiovascular, or neurological disorder that could inhibit them from exercising; inability or unwillingness to undertake upper- and lower-limb exercise training; unwillingness or inability (lactose intolerance) to consume whey protein supplementation after each exercise session; and having performed resistance training in the previous 6 months.

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
Safety/efficacy
Statistical methods / analysis
A linear mixed-effects model will be used with participant ID as the random-effects factor. The assumption of normality and homoscedasticity of the residuals will be verified by visual quantile-quantile plot inspection of the plots and a Shapiro-Wilk test. In the case of a significant interaction effect, pairwise comparisons will be performed between conditions and timepoints, with a Holm’s P value adjustment. The criterion significance level will be set to P less than or equal to 0.05. All statistical testing will be performed using R (R Core Team) using the package lmerTest. Data will be presented as means (95% confidence intervals).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/06/2021
Actual
18/06/2021
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
14
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 33493 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 308164 0
University
Name [1] 308164 0
Edith Cowan University
Country [1] 308164 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr, Joondalup 6027, WA
Country
Australia
Secondary sponsor category [1] 308932 0
None
Name [1] 308932 0
Address [1] 308932 0
Country [1] 308932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308150 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 308150 0
Ethics committee country [1] 308150 0
Australia
Date submitted for ethics approval [1] 308150 0
20/01/2021
Approval date [1] 308150 0
27/01/2021
Ethics approval number [1] 308150 0
2020-02012-MAVROPALIAS

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

Contacts
Principal investigator
Name 109706 0
Dr Robert Newton
Address 109706 0
Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia
Country 109706 0
Australia
Phone 109706 0
+61863043443
Fax 109706 0
Email 109706 0
[email protected]
Contact person for public queries
Name 109707 0
Georgios Mavropalias
Address 109707 0
Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia
Country 109707 0
Australia
Phone 109707 0
+61863046726
Fax 109707 0
Email 109707 0
[email protected]
Contact person for scientific queries
Name 109708 0
Georgios Mavropalias
Address 109708 0
Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia
Country 109708 0
Australia
Phone 109708 0
+61863046726
Fax 109708 0
Email 109708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11120Study protocol  [email protected] 381662-(Uploaded-22-03-2021-17-44-48)-Study-related document.pdf



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.