Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001561774
Ethics application status
Approved
Date submitted
6/12/2022
Date registered
19/12/2022
Date last updated
19/12/2022
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Resistance exercise effects on self-efficacy and psychological health in people diagnosed with cancer.
Scientific title
Investigating the effects of six-week resistance training exercise intervention on self-efficacy, self-esteem, and psychological health outcome measures in individuals with cancer
Secondary ID [1] 308560 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 328422 0
Psychological health 328423 0
Depression 328474 0
Anxiety 328475 0
Psychological stress 328476 0
Condition category
Condition code
Cancer 325442 325442 0 0
Any cancer
Mental Health 325443 325443 0 0
Depression
Mental Health 325444 325444 0 0
Anxiety
Mental Health 325445 325445 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six-week resistance exercise intervention, involving three weekly 60-minute sessions (Mon, Tues & Friday).

The intervention will involve participants engaging with a tailored resistance exercise program that involves repeated muscular contractions against an external load (weights, resistance bands, exercise machines, or participants own body weight). These sessions will aim to engage most major muscle groups and adhere to recommendations from Exercise & Sport Science Australia for frequency, intensity and volume of exercise prescribed.

An accredited exercise physiologist will conduct all pre-/post-intervention assessments, prescribe and deliver the intervention and monitor participants throughout for safety purposes.

The intervention design is a prospective experimental trial, using a stepped methodology. All participants recruited will receive the intervention at various time points. Participants will be randomly assigned to one of three intervention arms: immediate intervention; wait-list control; and delayed. Once the immediate arm have completed their six-week intervention, the wait-list control arm will begin the intervention and the delayed arm will act as wait-list controls. The immediate arm will be able to provide follow-up data.

The exercise intervention will be delivered in small groups <10 participants at the Canberra Specialist Medical Centre gym.

Exercise intensity will be prescribed between moderate to vigorous intensities, and will be quantified using general RPE scale (0-10). Moderate to vigorous intensities is considered as 5-7/10 on the general RPE scale.

Exercise selection will be based on individual needs / goals. The equipment used will include a variety of machines, free weights (dumbbells, kettlebells), resistance / power bands.

Example exercise that may be selected are leg press, chest press, seated row, lat-pull down, bicep curls, leg curls, leg extensions, tricep extensions, overhead press.

Outside of exercise sessions, will not discourage participants from being physical activity. We will monitor any additional exercise completed each week by participants via step counts and self-reported activity levels

We will include session attendance checklists and provide clients with hardcopy exercise programs which they can use to track exercise, more specifically their exertion levels and volume of exercise completed.
Intervention code [1] 325009 0
Treatment: Other
Comparator / control treatment
In this trial, the control arm will be considered active wait-list control, they will not be asked to disengage from any current physical activity or exercise routine. The wait-list control group will begin the intervention at week 7. The delayed group will being the intervention at week 13.

The maximum waiting time for the delayed group is 12-weeks.

The maximum follow up duration for the immediate arm is 12-weeks.

Total intervention duration is 18-weeks (three x six-week intervention periods).
Control group
Active

Outcomes
Primary outcome [1] 333302 0
Self-esteem

Assessed by the Rosenberg Self-Esteem Scale
Timepoint [1] 333302 0
All groups will complete at recruitment (delayed group) or pre-intervention and 1-week post intervention (immediate, wait-list, and delayed).

Each group will additionally complete follow up measures at 6-weeks and 12-weeks post intervention.
Primary outcome [2] 333303 0
Psychological health

Assessed by the Hospital Anxiety and Depression Scale
Timepoint [2] 333303 0
All groups will complete at recruitment (delayed group) or pre-intervention and 1-week post intervention (immediate, wait-list, and delayed).

Each group will additionally complete follow up measures at 6-weeks and 12-weeks post intervention.
Primary outcome [3] 333352 0
Exercise self-efficacy

Assessed by the Exercise Self-efficacy scale
Timepoint [3] 333352 0
All groups will complete at recruitment (delayed group) or pre-intervention and 1-week post intervention (immediate, wait-list, and delayed).

Each group will additionally complete follow up measures at 6-weeks and 12-weeks post intervention.
Secondary outcome [1] 416558 0
Aerobic capacity

Assessed using a stationary cycle ergometer with a sub-maximal protocol
Timepoint [1] 416558 0
These physical assessments will only be completed at pre and 1-week post intervention, for all groups
Secondary outcome [2] 416559 0
Lower body muscular strength

10-RM Leg press assessments for both quadriceps, glutes, hamstrings
Timepoint [2] 416559 0
These physical assessments will only be completed at pre and 1-week post intervention, for all groups
Secondary outcome [3] 416718 0
Upper body strength assessment

10-RM chest press to assess strength of pectoralis major, deltoids, triceps. These muscles will be assessed as a composite secondary outcome.

Timepoint [3] 416718 0
These physical assessments will only be completed at pre and 1-week post intervention, for all groups

Eligibility
Key inclusion criteria
Diagnosis of cancer
18 years of age or older
Able to provide written informed consent
Cleared by their primary care physician or oncologist to participate in face to face exercise program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of any absolute contraindications to exercise testing and participation, as described by the American College of Sports Medicine (ACSM).

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 concealed through central randomisation on a computer, once participants had been determined eligible and enrolled in the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped design methodology

Participants will be randomly assigned to either immediate exercise, waitlist arm or delayed arm.

The immediate exercise group will receive the first intervention interval, once this is completed the waitlist arm will receive the second interval and the delayed will become considered the control arm. The delayed exercise arm will receive the third and final intervention interval.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data cleaned and analysed using SPSS statistical analysis software. Statistical analysis will include a mixture of repeated measures ANOVAs, t-tests, and regression techniques, as appropriate, based on the final data characteristics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
15/06/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 39120 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 312811 0
University
Name [1] 312811 0
University of Canberra
Country [1] 312811 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 314456 0
None
Name [1] 314456 0
Address [1] 314456 0
Country [1] 314456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312092 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 312092 0
11 Kirinari Street, Bruce ACT, 2617
Ethics committee country [1] 312092 0
Australia
Date submitted for ethics approval [1] 312092 0
16/09/2022
Approval date [1] 312092 0
28/10/2022
Ethics approval number [1] 312092 0
11830

Summary
Brief summary
This study aims to investigate the effects of a resistance exercise program on the self-esteem, mental health and self-efficacy of people living with cancer.

Who is it for?
You may be eligible for this study if you are an adult ages 18 years or older, you have been diagnosed with any type of cancer, including metastatic or widespread cancers and you have received approval from your primary care doctor to complete an exercise program.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three treatment groups. Participants who are allocated to the first treatment group will start the exercise program within 1 week of enrolling in the study. The exercise program will involve attending 3x 1 hour sessions per week for 6 weeks (Monday, Tuesday & Friday). These sessions will be delivered one-on-one between participants and an accredited exercise physiologist who will create a personalised exercise regime for each participant and supervise them during each session. Exercises may involve repeated muscular contractions using weights, resistance bands, exercise machines, or participants' own body weight.
Participants who are allocated to the second treatment group will not start their exercise program until 6 weeks after enrolling in the study. Participants who are allocated to the third treatment group will not start their exercise program until 12 weeks after enrolling in the study. During the waiting period, participants in both of these groups will be able to continue with their current exercise routines (if they have one). The exercise program will then be delivered to both of these groups in the same manner as for participants in the first treatment group.

It is hoped this research will determine whether a resistance exercise program has a positive impact on the mental health, self-esteem and physical wellbeing of people living with cancer. If this study shows a positive impact on participants' wellbeing, it may be expanded to a larger number of hospital locations so that a greater number of people living with cancer may undertake this program as part of their usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123446 0
Mr Jay Calder
Address 123446 0
University of Canberra
11 Kirinari Street, Bruce ACT, 2617
Country 123446 0
Australia
Phone 123446 0
+61 411607004
Fax 123446 0
Email 123446 0
jay.calder@canberra.edu.au
Contact person for public queries
Name 123447 0
Mr Jay Calder
Address 123447 0
University of Canberra
11 Kirinari Street, Bruce ACT, 2617
Country 123447 0
Australia
Phone 123447 0
+61 411607004
Fax 123447 0
Email 123447 0
jay.calder@canberra.edu.au
Contact person for scientific queries
Name 123448 0
Mr Jay Calder
Address 123448 0
University of Canberra
11 Kirinari Street, Bruce ACT, 2617
Country 123448 0
Australia
Phone 123448 0
+61 411607004
Fax 123448 0
Email 123448 0
jay.calder@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is not planned to be shared due to confidentiality rationales, the cleaned measures of central tendency and dispersion data is adequate for testing hypothesis and answering research questions.


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.