Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061468) titled 'The effect of abdominal hot compress on constipation in Parkinson's disease patients: A randomized controlled trial' on May 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Japanese Red Cross Hiroshima College of Nursing
Condition:
Condition - Parkinson's disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to clarify, through a randomized controlled trial, whether abdominal hot compress intervention once a day for one week has the effect of alleviating constipation symptoms in Parkinson's disease (PD) patients with constipation. A secondary objective is to evaluate the impact of this intervention on quality of life (QOL).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In addition to usual care, apply a steam generating heat sheet to the abdomen for 5 hours once daily for one week.
Interventions/Control_2 - Receive only usual care without the application of a steam generating heat sheet.
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - (Eligibility summary)
Inpatients diagnosed with Parkinson's disease, who have sufficient cognitive function for study participation, and whose general condition is judged as stable by their primary physician.
(Inclusion criteria)
1. Patients currently taking medication for constipation.
2. Patients with a total score of 1 or higher on the Japanese version of the Constipation Assessment Scale-LT (CAS-LT).
3. Patients at Hoehn and Yahr stages I to IV.
4. Patients aged between 65 and 84 years.
Key exclusion criteria - 1. Patients with an MMSE score of 23/30 or less (based on data within the past 6 months from the time of registration).
2. Patients with a history of abdominal surgery.
3. Patients with diseases or symptoms that could be worsened by heat stimulation (e.g., multiple sclerosis, skin diseases), as judged by the primary physician.
4. Other patients judged by the physician to be inappropriate for participation in the study.
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 04 Month 22 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069967
Disclaimer: Curated by HT Syndication.