Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000498695
Ethics application status
Approved
Date submitted
6/05/2014
Date registered
12/05/2014
Date last updated
3/12/2020
Date data sharing statement initially provided
8/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of walking as an effective treatment for constipation in patients taking antipsychotic medication within a mental health setting.
Scientific title
The use of walking as an effective treatment of constipation in patients prescribed antipsychotic medication compared to patients not receiving the intervention.
Secondary ID [1] 284544 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 291807 0
Users of antipsychotic medications. 291808 0
Condition category
Condition code
Mental Health 292169 292169 0 0
Schizophrenia
Mental Health 292170 292170 0 0
Psychosis and personality disorders
Oral and Gastrointestinal 292203 292203 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will complete exercise of walking on a treadmill. This will occur for 15 minutes, on 3 days within a 7 day period, throughout the 6 week trial period. Two treadmills will be used; a SportsArt T625 and an Impulse AC3170C. There will be a research staff member supervising while participants are using the treadmills. Participants will be trained in the correct use of a treadmill, and informed of the risks and benefits upon entering into the study and throughout as required. The walking speed of the treadmill will be determined by the participants' 6 Minute Walk Test (6MWT). This test will be performed on each participant at their initial appointment and the treadmill will be set at 80% of their maximum walking speed. This speed will remain the same for each participant throughout the trial.
In addition to walking, each participant will receive a pamphlet which describes constipation and explains ways in which to manage the symptoms. All participants will also be encouraged to attend at least one nutritional advice session with a dietitian.
Participants will be expected to continue with any regime they were using at enrolement to manage their constipation (eg. laxative use).
Intervention code [1] 289303 0
Treatment: Other
Intervention code [2] 289304 0
Lifestyle
Comparator / control treatment
Participants will be expected to undertake their usual regime of managing constipation (eg. laxative use). In addition, all participants will be given a pamphlet describing constipation and explaining ways in which to manage the symptoms. Each participant will also be encouraged to attend at least one nutritional advice session from a dietitian. These sessions are 30 minutes in length and are offered as a weekly group session. Participants may attend as many as they wish as the sessions will cover different topics. These sessions will remain in place after the trial ends, but attendance will only be recorded during the 6 week trial period.
Control group
Active

Outcomes
Primary outcome [1] 292050 0
Decrease in symptoms of constipation greater than that of the control group. This will be assessed by participant self-report on the Modified Constipation Assessment Scale, the Modified ROME III Questionnaire - Constipation Module, and the Bristol Stool Chart Type.
Timepoint [1] 292050 0
This will be measured at baseline, at the end of every 7 day trial period and at the end of the 6 week trial period.
Primary outcome [2] 292051 0
Increase on self-report measures of psychological health and well-being that is greater than any increase in the control group. Self esteem will be measured by the Rosenberg Self-Esteem Scale, quality of life will be measured by the SF-12 version 2 Health and Wellbeing Scale, and psychological distress will be measured by the Depression, Anxiety and Stress Scales.
Timepoint [2] 292051 0
These will be measured at baseline, at 3 weeks (half-way point) and at the end of the 6 week trial period.
Primary outcome [3] 292052 0
Increase in scores on physical health measures. This will be assessed by the participants' waist circumference, Body Mass Index, and 6 Minute Walk Test.
Timepoint [3] 292052 0
These will be measured at baseline, at the end of every 7 day trial period, and at the end of the 6 week trial period.
Secondary outcome [1] 308078 0
Decrease in symptoms of constipation in the control group as a result of the written and verbal information on the management of constipation. This will be measured by the Modified Constipation Assessment Scale, the Modified ROME III Questionnaire - Constipation Module, and the Bristol Stool Chart Type.
Timepoint [1] 308078 0
These will be measured at baseline, at the end of every 7 day trial period, and at the end of the 6 week trial period.

Eligibility
Key inclusion criteria
Aged 18 – 65.
Current prescription of at least one antipsychotic medication.
Diagnosed with functional constipation according to the Modified ROME III Questionnaire - Constipation Module.
Currently in a clinically stable condition.
Currently an inpatient at a specific psychiatric hospital in Perth, Western Australia.
Expected length of stay >4 weeks.
Proficient in English.
Confirmation of medication and suitability for the study by the participants’ treating psychiatrist.
Ability to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged <18 or >65.
Not currently prescribed antipsychotic medication.
No diagnosis of functional constipation according to the criteria of the Modified ROME III Questionnaire - Constipation Module.
Current or history of gastrointestinal surgery or disease.
Requires mobility aid.
Inability to walk unaided on a treadmill for 15 minutes at a time.
Not currently clinically stable.
Not currently an inpatient at a specific psychiatric hospital in Perth, Western Australia.
Expected length of stay <4 weeks.
Not proficient in English.
Treating psychiatrist believes patient is not suitable to participate for any reason (physical, psychological, or other).
Inability to provide informed consent.
Weight above 185 kg (weight limit of treadmills).
Pregnant or breastfeeding (applicable to females only).

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)
Eligiable participants will either be approached by the research team, or referred by their psychiatrist. The participants will be allocated into the treatment groups based on their entry into the study (ie. the first participant will be placed in the treatment group, the second in the control group, and so on). In this way, allocation is not concealed.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The G-Power program (version 3.1.0) was used to determine sample size. It is estimated that for (a) given sample size (N=10, including 0% attrition rate), (b) medium to large effect size (f=0.25-0.35), (c) six repeated assessments, and (d) substantial correlation between repeated assessments (e.g., r=>0.50), our study will achieve compelling statistical power of 0.80. As we will continue recruiting until 20 participants have completed 6 weeks of the trial, and it is estimated we will have additional data from participants withdrawing or being terminated from the study after the 3 week period, our study will have power to find significance if it exists.

Data analysis will be conducted using the IBM SPSS version 21. First, independent samples t-tests will be conducted to check for significant differences between the two groups. Next, Mahalanobis distance estimates and visual inspection of the box plots will identify extreme values. For testing of the hypotheses and to evaluate function change within the treatment group, we will employ a Generalised Linear Model (GLM) Repeated Measures design. This mixed design procedure is commonly used to model dependent variables measured at multiple times (there will be 6 repeated assessments in this trial) to compare the treatment group to the control group. The level of statistical significance will be set at 0.05 for all analyses.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
16/06/2014
Actual
17/12/2015
Date of last participant enrolment
Anticipated
12/07/2020
Actual
25/07/2019
Date of last data collection
Anticipated
Actual
22/08/2019
Sample size
Target
20
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2413 0
Graylands Selby-Lemnos & Special Care Hospital - Mount Claremont
Recruitment postcode(s) [1] 8051 0
6010 - Mount Claremont

Funding & Sponsors
Funding source category [1] 289176 0
Hospital
Name [1] 289176 0
Physiotherapy Department of Graylands Hospital (within departmental funds)
Country [1] 289176 0
Australia
Primary sponsor type
Individual
Name
Michael Sitas
Address
Fitzroy House, Graylands Hospital
Brockway Road Mt Claremont
WA 6010
Country
Australia
Secondary sponsor category [1] 287845 0
Individual
Name [1] 287845 0
Kevin Lau
Address [1] 287845 0
Fitzroy House, Graylands Hospital
Brockway Rd Mt Claremont
WA 6010
Country [1] 287845 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290952 0
North Metropolitan Health Service - Mental Health (NMHS-MH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 290952 0
Ethics committee country [1] 290952 0
Australia
Date submitted for ethics approval [1] 290952 0
13/03/2014
Approval date [1] 290952 0
10/10/2014
Ethics approval number [1] 290952 0
02_2014

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

Contacts
Principal investigator
Name 48106 0
Mr S L Kevin Lau
Address 48106 0
Fitzroy House Graylands Hospital
Physiotherapy Department
Locked Bag No. 1
PO Claremont WA 6910
Country 48106 0
Australia
Phone 48106 0
+61 8 9347 6821
Fax 48106 0
Email 48106 0
[email protected]
Contact person for public queries
Name 48107 0
S L Kevin Lau
Address 48107 0
Fitzroy House Graylands Hospital
Physiotherapy Department
Locked Bag No. 1
PO Claremont WA 6910
Country 48107 0
Australia
Phone 48107 0
+61 8 9347 6821
Fax 48107 0
Email 48107 0
[email protected]
Contact person for scientific queries
Name 48108 0
S L Kevin Lau
Address 48108 0
Fitzroy House Graylands Hospital
Physiotherapy Department
Locked Bag No. 1
PO Claremont WA 6910
Country 48108 0
Australia
Phone 48108 0
+61 8 9347 6821
Fax 48108 0
Email 48108 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
Confidentiality


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.