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Trial registered on ANZCTR
Registration number
ACTRN12626001091392
Ethics application status
Approved
Date submitted
4/06/2026
Date registered
3/09/2026
Date last updated
3/09/2026
Date data sharing statement initially provided
3/09/2026
Type of registration
Retrospectively registered
Titles & IDs
Public title
Targeted exercise for quality of life and physical condition in people who have undergone stoma formation living without a parastomal hernia: a feasibility study
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Scientific title
Targeted exercise for quality of life and physical condition in people who have undergone stoma formation living without a parastomal hernia: a feasibility study
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Additional trial identifiers [1]
317493
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
stoma without a parastomal hernia
342210
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Physical inactivity
342211
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Quality of Life
342803
0
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Condition category
Condition code
Musculoskeletal
338328
338328
0
0
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Other muscular and skeletal disorders
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Surgery
338714
338714
0
0
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Other surgery
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Oral and Gastrointestinal
338715
338715
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Arm 1 only - All participants will receive the intervention.
- All participants were allocated to receive the exercise intervention comprising 4-6 face to face sessions delivered fortnightly by a physiotherapist.
- Exercise intervention aimed at improving abdominal muscle function and physical activity levels
The first Physiotherapy session (45-90 minutes) incorporated an assessment of the ostomate’s knowledge and skills regarding abdominal muscle exercise. Next, motivational interviewing using the Brief Action Planning (BAP) approach was used to establish a SMART goal around exercise and guide ostomates to plan exercise details such type and frequency of exercises to be conducted in the home exercise program.
Consenting participants received verbal, written and video feedback (recorded on their own personal device and used only for their person) on the exercises so that they can continue these at home, to provide them with visual feedback and remind them of what is required.
Participants were asked to complete paper-based exercise diary to record the exercises completed and report any concerns to the led investigator.
At each subsequent session (30-60 minutes), the physiotherapist reviewed the participants diary and progressed the exercises.
Examples of exercises undertaken included: engaging the core/pelvic floor engagement "like doing up the zipper on your pants", diaphragm breathing, crook lying down, knees side to side lying down, bridging, knee lifts in crook position, heel glides, sitting with arm raises, sitting with knee lifts, sit to stand, quadruped with arm raises and leg raises, diagonal sit ups, legs from side to side laying down (taken from previous research by Anderson and colleagues), walking, running, dead lifts.
These were individually prescribed and it was expected that not all participants were able to achieve/prescribed all the exercises.
Physiotherapist / Research Assistant training
Prior to commencement of the study, the Physiotherapist administering the exercise program attended a two-hour training session by the study investigators summarising the evidence for core abdominal exercises for parastomal hernia prevention, behaviour change techniques, as well as a discussion of broader ostomate healthcare issues including surgical procedure, type of stoma (ileostomy, colostomy or urinary stoma), peristomal skin condition and any appliance issues including the use of hernia support garment.
The physiotherapist-researcher completed an online module on an overview on motivational interviewing using the Brief Action Planning (BAP) approach to establish a SMART goals.
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Intervention code [1]
334284
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Rehabilitation
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Intervention code [2]
334539
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Lifestyle
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Intervention code [3]
334540
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Behaviour
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Description of the comparator or control
No comparator / No control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
345651
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Intervention acceptability (composite outcome)
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Assessment method [1]
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Participant perceptions of the intervention were evaluated via four open ended questions in a paper survey to report individual needs, benefits, barriers and enablers of the intervention.
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Timepoint [1]
345651
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week 0 (commencement of intervention) week 12 (end of intervention), week 52 (final data collection)
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Primary outcome [2]
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Intervention fidelity (composite outcome)
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Assessment method [2]
345928
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The number of treatment sessions will be calculated from treatment notes. Individual goals, exercise prescription and exercise adherence were summarised quantitatively or qualitatively from participant workbooks
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Timepoint [2]
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Week 12 (end of intervention)
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Primary outcome [3]
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Intervention safety
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Assessment method [3]
345929
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Participants were asked to report any adverse events encountered during the study period via follow-up surveys or phone call to the chief researcher. In each follow-up survey, participants were asked if they had any new or worsening problems with pain/discomfort, appliance issues, passing faeces/urine, visible bulge or other. All adverse events were evaluated by the chief researcher and Serious adverse events (SAE) were reviewed by a member of the clinical advisory board. The Common Terminology Criteria for Adverse Events (CTCAE Version 5, 2017) was used to summarise the number and grade of adverse events.
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Timepoint [3]
345929
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week 0 (commencement of intervention) week 12 (end of intervention), week 52 (final data collection)
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Secondary outcome [1]
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Retention rate
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Assessment method [1]
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Retention rate was defined as the proportion of participants completing follow-up at week 12 and one year, as determined from completion of assessments and questionnaires collected at each time point and taken from SPSS.
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Timepoint [1]
462693
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week 0 (commencement of intervention) week 12 (end of intervention), week 52 (final data collection)
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Secondary outcome [2]
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Reach and Consent rate (as a composite outcome)
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Assessment method [2]
463800
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Reach was determined from estimated numbers of people receiving paper invites from QSA and emails or Facebook advertisements. Consent rate was defined as the proportion of eligible participants that consented divided by the number of participants who enquired about the study. Data was recorded and taken from study logbook.
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Timepoint [2]
463800
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week 0 - prior to starting baseline
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Secondary outcome [3]
463801
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Floor rise to standing test –
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Assessment method [3]
463801
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time to move from a supine position to upright standing will be measured (Coombes & Skinner, 2021)
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Timepoint [3]
463801
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week 0 (commencement of intervention) week 12 (end of intervention)
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Secondary outcome [4]
463802
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Timed up and go test
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Assessment method [4]
463802
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– time to stand up and walk (Coombes & Skinner, 2021)
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Timepoint [4]
463802
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week 0 (commencement of intervention) week 12 (end of intervention)
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Secondary outcome [5]
463803
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Waist circumference and hip circumference as a composite secondary outcome
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Assessment method [5]
463803
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waist hip ratio using measuring tape, measured in centimetres
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Timepoint [5]
463803
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week 0 (commencement of intervention) week 12 (end of intervention)
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Secondary outcome [6]
463804
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Abdomen circumference at the level of the stoma
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Assessment method [6]
463804
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centimetres using a measuring tape
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Timepoint [6]
463804
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week 0 (commencement of intervention) week 12 (end of intervention)
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Secondary outcome [7]
464802
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weight
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Assessment method [7]
464802
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weight in kilograms via electronic standing scales
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Timepoint [7]
464802
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week 0 (commencement of intervention) week 12 (end of intervention)
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Secondary outcome [8]
466347
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Ultrasound examination of core abdominal muscle function as composite secondary outcome
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Assessment method [8]
466347
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Outcomes include thickness of the TrA and oblique abdominal muscles at rest and when contracted, as well as assessment of the back muscles and breathing pattern. through the use of ultrasound. Comparisons between pre-intervention (time 1 - week 0) and post-intervention (time 2 - week 12) for muscle size (multifidus and QL), muscle contraction (multifidus and TrA/IO) and abdominal muscle thickness at rest (TrA and IO) are combined to show change per person. Due to anticipated small numbers in the ultrasound cohort, results may be discussed in a descriptive manner or case series.
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Timepoint [8]
466347
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Week 0 (commencement of intervention), 12 (end of intervention)
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Secondary outcome [9]
466348
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Sit to stand test
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Assessment method [9]
466348
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Time to complete five sit to stands will be measured using a stopwatch using standardised cues (Coombes & Skinner, 2021)
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Timepoint [9]
466348
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Week 0 (commencement of intervention), 12 (end of intervention)
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Secondary outcome [10]
466349
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Patient reported outcome - Global perceived effect "With respect to your physical health how would you describe yourself now compared to before commencing the targeted exercise program"
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Assessment method [10]
466349
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5 point likert scale, from much worse (-2) to much better (+2)
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Timepoint [10]
466349
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(After the intervention) Week 12, 26, 52
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Secondary outcome [11]
466350
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Health related quality of life
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Assessment method [11]
466350
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SF-36
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Timepoint [11]
466350
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Secondary outcome [12]
466351
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Stoma related quality of life
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Assessment method [12]
466351
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Stoma-QOL 20 item questionnaire
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Timepoint [12]
466351
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Secondary outcome [13]
466352
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Patient-specific function
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Assessment method [13]
466352
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Patient-specific function scale - Participants chose 3 activities that they were currently (at the time of the intervention) limited in doing, then rated current function for each activity on the following scale from 0 to 10, where 0 means - unable to perform the activity and 10 means - can perform without difficulty. Participants were asked to choose activities that were meaningful and realistic to improve in.
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Timepoint [13]
466352
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Secondary outcome [14]
466353
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Musculoskeletal trouble (ache, pain, discomfort)
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Assessment method [14]
466353
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Nordic Musculoskeletal questionnaire measured trouble in the last 7 days and the worst level of pain in the last 7 days on a 0-10 numerical scale.
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Timepoint [14]
466353
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Secondary outcome [15]
466354
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Fear of injury
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Assessment method [15]
466354
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Tampa scale of Kinesiophobia item 1 using 4 point likert scale
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Timepoint [15]
466354
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Secondary outcome [16]
466355
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Physical activity
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Assessment method [16]
466355
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Active Australia Questionnaire 8 items
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Timepoint [16]
466355
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week 0 (commencement of the intervention), 12 (end of the intervention), 26 and 52
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Eligibility
Key inclusion criteria
Adult participants (aged 18 years or more ) with a stoma [Colostomy (large bowel) / Ileostomy (small bowel) / Ileal/colonic conduit/ urostomy (urinary stoma)] were invited to participate.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Ostomates with a definite or probable parastomal hernia. This may be based on clinical diagnosis or imaging, or on the decision made by the principal investigator during the screening phase of the research.
Ostomates unable to ambulate and transfer independently.
Ostomates unable to travel to Metro North Community Health Centre for testing of program requirements.
Ostomates unable to understand written and verbal instructions and questionnaires.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All data were entered and analysed using IBM SPSS Statistical package version 30.0.
All data were double checked for accuracy of data entry to minimise error.
Descriptive statistics will be used to describe the sample, consent and retention rates. Secondary outcomes will be assessed using parametric or non-parametric tests depending on their distribution. Free-text responses will be tabulated and all comments will be presented to contextualise the overall feedback.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Lack of funding
staff
and/or facilities
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Date of first participant enrolment
Anticipated
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Actual
19/06/2023
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Date of last participant enrolment
Anticipated
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Actual
29/06/2023
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Date of last data collection
Anticipated
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Actual
31/05/2024
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Sample size
Target
30
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
322060
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Other Collaborative groups
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Name [1]
322060
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Queensland Health - COH Research Grant
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Address [1]
322060
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Country [1]
322060
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Australia
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Funding source category [2]
322061
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University
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Name [2]
322061
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PhD research monies - Griffith University Nathan Campus, Brisbane
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Address [2]
322061
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Country [2]
322061
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Australia
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Primary sponsor type
Government body
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Name
Community and Oral Health Reseach Grant, Queensland Health
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Address
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Country
Australia
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Secondary sponsor category [1]
324940
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University
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Name [1]
324940
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Griffith University, Nathan Campus
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Address [1]
324940
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Country [1]
324940
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320589
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
320589
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https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
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Ethics committee country [1]
320589
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Australia
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Date submitted for ethics approval [1]
320589
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Approval date [1]
320589
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28/03/2023
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Ethics approval number [1]
320589
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HREC/2023/QGC/94368
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Ethics committee name [2]
320590
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Griffith University Human Research Ethics Committee
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Ethics committee address [2]
320590
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https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
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Ethics committee country [2]
320590
0
Australia
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Date submitted for ethics approval [2]
320590
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Approval date [2]
320590
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04/04/2023
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Ethics approval number [2]
320590
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GU/2023/230
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Summary
Brief summary
This co-designed single-arm feasibility study explored whether or not a tailored exercise program was feasible, safe and acceptable to implement, in people living with a stoma and without a parastomal hernia, It was delivered by skilled physiotherapists, with individual personally tailored sessions, face to face over a 3-month period, with 12 people completing the program. It had no major adverse events and those living with a stoma, without a parastomal hernia, reported positive experiences.
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Trial website
nil
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Monica Stankiewicz
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Address
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Chermside Community Health Centre, 490 Hamilton Rd, Chermside, Brisbane Queensland 4032
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Country
150986
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Australia
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Phone
150986
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+61 731394127
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Fax
150986
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Email
150986
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[email protected]
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Contact person for public queries
Name
150987
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Monica Stankiewicz
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Address
150987
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Chermside Community Health Centre, 490 Hamilton Rd, Chermside, Brisbane Queensland 4032
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Country
150987
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Australia
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Phone
150987
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+61 731394127
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Fax
150987
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Email
150987
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[email protected]
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Contact person for scientific queries
Name
150988
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Monica Stankiewicz
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Address
150988
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Chermside Community Health Centre, 490 Hamilton Rd, Chermside, Brisbane Queensland 4032
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Country
150988
0
Australia
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Phone
150988
0
+61 731394127
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Fax
150988
0
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Email
150988
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Health economic analyses
•
Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
•
Journal publication or its supplementary materials:
Not yet published in journal, phd thesis in the first instance. The lead researcher Monica Stankiewicz can be contacted via email.
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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.
Download to PDF