Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000740796
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
23/05/2022
Date last updated
23/05/2022
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing constipation in Parkinson’s using self-care techniques.
Scientific title
Managing constipation in Parkinson’s using self-care techniques: A Quasi-experimental Pilot Study.
Secondary ID [1] 307105 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 326264 0
Parkinson's disease 326265 0
Condition category
Condition code
Alternative and Complementary Medicine 323568 323568 0 0
Other alternative and complementary medicine
Neurological 323624 323624 0 0
Parkinson's disease
Oral and Gastrointestinal 323625 323625 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
This is a self-management research project which will take place in the participants home, with all information posted or emailed, and telephone calls made throughout the study. Phone calls are expected to take approximately 10-15 minutes. The Researcher will be available for participants to phone at any time throughout the study and contact details are given at the beginning. Participants will receive information on self-care techniques, with one technique sent daily over a week, starting off with general and safety information, then followed by Reflexology, Fluid intake, Diet and fibre, Toilet routines, Medications and Exercise. They will be required to choose 2-3 techniques to incorporate into their lifestyle for the intervention phase. A phone call will be made at the end of the week by the researcher (a Registered Nurse) to ask which techniques they have chosen and answer any questions. During the 3-week treatment phase participants will be asked to continually complete a bowel diary and document lifestyle techniques used daily and they will be phoned weekly to check well-being, provide support and encourage adherence.
General and safety information-overview of constipation, risk factors, lifestyle modifications and safety information including Red flags to watch out for and when to seek medical assistance.
Reflexology-It has been around since ancient Egyptian times and works by applying pressure to reflex points on the hands or feet, which correspond to areas on the body. Every part of the body has a corresponding reflex area, so the hands and feet are micro-maps of the body. A self-care Reflexology technique has been formulated for constipation which will be outlined in a short video with the aim that the techniques should only take about 5 minutes to run through daily.
Fluid intake-Inadequate fluid intake is thought to be a contributing factor to constipation. Participants are encouraged to calculate their daily fluid requirement, weight multiplied by 30mls. Then keep track on how much fluid they are drinking to ensure they meet their target each day.
Diet and fibre-Dietary fibre is discussed, as well as foods with a natural laxative effect. Participants are encouraged to eat five servings of fruit and vegetables each day and a healthy diet should contain fibre from a variety of sources. It is suggested that they make changes to their diet slowly to prevent bloating and drink plenty of fluids alongside increasing fibre intake, as well as minimise low fibre starchy foods.
Toilet routines-Peristalsis is stimulated by eating breakfast, so the best time to open your bowels is around 20 minutes after breakfast or a hot drink in the morning (Kyle, 2008; Parkinson’s New Zealand, 2011). Privacy is needed when using the toilet and positioning is helpful. Participants are encouraged to establish a bowel routine and take advantage of the gastro-colic reflex by making time to sit on the toilet after meals, particularly after breakfast and think about their seating position on the toilet. A correct seating position diagram will be provided.
Medications-Constipation can be a side effect of some medications and is more likely to occur when taking five or more different medications (Barichella et al., 2016; Kyle, 2008; S. Thomas, 2014). Participants will be encouraged to talk to their pharmacist about reviewing both prescription and over-the-counter medications. They will be advised to take their medications, so they are “on” when the gastro-colic reflex is working. It will be highlighted that it is not advisable to make any medication changes or stop taking medications without consulting their doctor, as some medications should NOT be stopped abruptly and need to be reduced slowly.
Exercise-Exercise prevents constipation through stimulating peristaltic movement in the bowel and keeps our muscles strong (Nazarko, 2005; Parkinson’s New Zealand, 2011). Studies have shown that walking 0.5 km per day is sufficient to prevent constipation (Kyle, 2008). Participants will be encouraged to aim for at least 30 minutes of exercise each day and choose an activity they enjoy, so it is not a chore.

Intervention code [1] 323554 0
Treatment: Other
Intervention code [2] 323555 0
Behaviour
Intervention code [3] 323556 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331324 0
Any change in constipation will be assessed as an individual outcome through the use of a bowel diary, compared before and after intervention.
Timepoint [1] 331324 0
Baseline and 6 weeks, post-intervention completion
Primary outcome [2] 331386 0
Any change in constipation will be assessed as an individual outcome through the use of the Constipation Severity Instrument., compared before and after intervention.
Timepoint [2] 331386 0
Baseline and 6 weeks, post-intervention completion
Secondary outcome [1] 409533 0
Any change in quality of life assessed using the NZ WHO-QOL BREF questionnaire.
Timepoint [1] 409533 0
Baseline and 6 weeks, post-intervention completion

Eligibility
Key inclusion criteria
Inclusion criteria: Diagnosis of Idiopathic Parkinson’s, Hoehn & Yahr (H&Y) stage 1-3, resides in Canterbury, constipation defined according to the Rome III criteria and currently using laxatives regularly, medically stable with no history of bowel disease, mentally and physically able.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Any Parkinsonian syndrome, H&Y stage 4-5, do not speak English, bowel disease or previous surgery on the GI tract, an urgent medical condition, dementia, allergy to corn, (corn test required to check colon transit time), pregnant, already seeing a complementary therapist.

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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants are presented with 6 interventions and get to choose 2-3 of these.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Following exploring sample sizes for pilot studies and consulting with a statistician, the sample size required for this pilot study will be up to 15 participants to enable adequate data collection and allow for dropouts. In relation to previous research, Woodward et al. (2010) had 19 participants in a pilot study looking at the effectiveness of reflexology on idiopathic constipation and Johns et al. (2010) used 16 people to assess if reflexology could improve well-being in Parkinson’s disease. The rule of thumb recommends a minimum 12 subjects per group for a pilot study (Julious, 2005). Being a pilot study with a small sample size, the effect on variables will be limited by having inclusion and exclusion criteria to minimise variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
Date of last participant enrolment
Anticipated
4/07/2022
Actual
Date of last data collection
Anticipated
22/08/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 24759 0
New Zealand
State/province [1] 24759 0
Canterbury

Funding & Sponsors
Funding source category [1] 311412 0
Self funded/Unfunded
Name [1] 311412 0
Bronwyn Alexander
Country [1] 311412 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
PO Box 600, Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 312801 0
Individual
Name [1] 312801 0
Bronwyn Alexander
Address [1] 312801 0
c/o Whanganui Hospital, 100 Heads Road, Gonville, Whanganui 4501
Country [1] 312801 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310891 0
HDEC Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310891 0
Ethics committee country [1] 310891 0
New Zealand
Date submitted for ethics approval [1] 310891 0
29/01/2022
Approval date [1] 310891 0
27/04/2022
Ethics approval number [1] 310891 0
2022 EXP 12155

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

Contacts
Principal investigator
Name 119250 0
Miss Bronwyn Alexander
Address 119250 0
c/o Whanganui Hospital, 100 Heads Road, Gonville, Whanganui 4501
Country 119250 0
New Zealand
Phone 119250 0
+64 272766643
Fax 119250 0
Email 119250 0
[email protected]
Contact person for public queries
Name 119251 0
Bronwyn Alexander
Address 119251 0
c/o Whanganui Hospital, 100 Heads Road, Gonville, Whanganui 4501
Country 119251 0
New Zealand
Phone 119251 0
+64 272766643
Fax 119251 0
Email 119251 0
[email protected]
Contact person for scientific queries
Name 119252 0
Bronwyn Alexander
Address 119252 0
c/o Whanganui Hospital, 100 Heads Road, Gonville, Whanganui 4501
Country 119252 0
New Zealand
Phone 119252 0
+64 272766643
Fax 119252 0
Email 119252 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
De-identified data will be collaborated into grouped results and a summary of these results will be disseminated. There will be no individual data shared.


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.