Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 5:01 PM
Study NCT ID:
NCT06401460
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yannianjiuzhuan Method and Reverse Breathing Training to Improve Constipation in Elderly Patients With Coronary Heart Disease
Sponsor:
Junfang Miao
Organization:
Study Overview
Official Title:
Gansu University of Chinese Medicine
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Purpose:
The primary purpose of this study is to evaluate the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in improving symptoms of constipation, anxiety, sleep quality, and overall quality of life in elderly patients with coronary heart disease and constipation.
Study Phase:
As this research involves a non-pharmacological intervention, it is categorized as Not Applicable (N/A).
Intervention Model:
Parallel Assignment. Patients are divided into two groups; one receives standard care, while the other receives standard care supplemented by the Yannianjiuzhuan method combined with reverse abdominal breathing.
Number of Arms:
Two arms are involved in the study. One arm serves as the control group receiving standard care, and the other as the experimental group receiving standard care plus the Yannianjiuzhuan method combined with reverse abdominal breathing.
Masking:
This study employed a double-blind (assessors and statisticians), randomized, parallel-controlled trial design to enhance the credibility of the results and to minimize bias.
Allocation:
Using simple random sampling, small folded papers marked with the numbers "1" and "2" were placed in an opaque box. Each patient drew a paper in sequence of enrollment; those drawing a "1" were assigned to the control group, and those drawing a "2" to the experimental group, with each group comprising 35 participants.
Enrollment:
A total of 70 patients were initially recruited, with 67 completing the study. The control group had one participant drop out due to early hospital discharge related to the pandemic, affecting data collection completeness. In the experimental group, one participant was excluded due to undergoing colonoscopy and taking related laxative medications during the treatment, and another due to early hospital discharge caused by the pandemic. Thus, data from three participants were excluded from the final analysis due to insufficient treatment duration (less than two-thirds of the planned intervention), resulting in 34 participants in the control group and 33 in the experimental group being analyzed, equating to a dropout rate of approximately 4.3%, which is within acceptable statistical limits.
Study Classification:
This study focuses on efficacy assessment. It particularly evaluates the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in alleviating symptoms of constipation, anxiety, improving sleep quality, and enhancing the quality of life among elderly patients with coronary heart disease and constipation.
The primary purpose of this study is to evaluate the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in improving symptoms of constipation, anxiety, sleep quality, and overall quality of life in elderly patients with coronary heart disease and constipation.
Study Phase:
As this research involves a non-pharmacological intervention, it is categorized as Not Applicable (N/A).
Intervention Model:
Parallel Assignment. Patients are divided into two groups; one receives standard care, while the other receives standard care supplemented by the Yannianjiuzhuan method combined with reverse abdominal breathing.
Number of Arms:
Two arms are involved in the study. One arm serves as the control group receiving standard care, and the other as the experimental group receiving standard care plus the Yannianjiuzhuan method combined with reverse abdominal breathing.
Masking:
This study employed a double-blind (assessors and statisticians), randomized, parallel-controlled trial design to enhance the credibility of the results and to minimize bias.
Allocation:
Using simple random sampling, small folded papers marked with the numbers "1" and "2" were placed in an opaque box. Each patient drew a paper in sequence of enrollment; those drawing a "1" were assigned to the control group, and those drawing a "2" to the experimental group, with each group comprising 35 participants.
Enrollment:
A total of 70 patients were initially recruited, with 67 completing the study. The control group had one participant drop out due to early hospital discharge related to the pandemic, affecting data collection completeness. In the experimental group, one participant was excluded due to undergoing colonoscopy and taking related laxative medications during the treatment, and another due to early hospital discharge caused by the pandemic. Thus, data from three participants were excluded from the final analysis due to insufficient treatment duration (less than two-thirds of the planned intervention), resulting in 34 participants in the control group and 33 in the experimental group being analyzed, equating to a dropout rate of approximately 4.3%, which is within acceptable statistical limits.
Study Classification:
This study focuses on efficacy assessment. It particularly evaluates the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in alleviating symptoms of constipation, anxiety, improving sleep quality, and enhancing the quality of life among elderly patients with coronary heart disease and constipation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: