None listed
Conditions
Brief summary
Constipation is highly prevalent among users of antipsychotic medication and is linked to physical issues such as bowel obstruction and paralytic ileus as well as psychological issues such as greater distress, poor mental health and low quality of life. Aside from the prescription of laxatives, the standard approach to reducing the symptoms of constipation is with increasing fibre into the diet, increasing fluid intake, and encouraging physical activity. It can be difficult to increase the amount of fibre and fluid in the diet in patients residing in a psychiatric hospital due to limited dietary options. Only one clinical trial assessing constipation in antipsychotic medication users could be found, while most studies exclude participants where medication is the likely cause of the constipation. The objectives of this study are to evaluate the effectiveness of regular exercise on constipation in patients prescribed antipsychotic medication within a psychiatric setting and to compare this treatment against receiving written and verbal information on constipation.
Interventions
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. T
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).
Sponsors
Michael Sitas
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed