Clinical trial NCT06401460: Yannianjiuzhuan Method and Reverse Breathing Training to Improve Constipation in Elderly Patients With Coronary Heart Disease
Official title: Gansu University of Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Coronary Heart Disease
Lead sponsor: Gansu University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 67
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Meets the diagnostic criteria for chronic stable coronary heart disease and constipation .
2. Aged 60 years and above but below 80 years.
3. Heart function classified as ≤ Class 2.
4. Clear consciousness, no language barriers, free of dementia or psychiatric history, and willing to comply with treatment.
5. Voluntarily participating in the study and has signed the informed consent form.

Exclusion Criteria:

1. Patients participating in other trials that could affect the results of this study.
2. Patients with organic constipation, refractory constipation, or fecal incontinence.
3. Patients with significant physical mobility impairments.
4. Patients suffering from severe metabolic diseases, cardiopulmonary diseases, hematological diseases, or psychiatric disorders.
5. Patients who have undergone abdominal surgery or other conditions unsuitable for abdominal massage within the past six months.
6. Patients who have taken medications affecting digestive functions and bowel movement in the past week.
7. Patients who underwent lumbar surgery within the past six months.
8. Patients assessed by doctors as having severe constipation symptoms, which could potentially worsen their condition.

Primary outcomes:
measure: PAC-SYM
timeFrame: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
measure: Bristol Stool Scale
timeFrame: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
measure: SAS
timeFrame: Before the intervention and after 10 days of intervention.
measure: PSQI
timeFrame: Before the intervention and after 10 days of intervention.
measure: PAC-QoL
timeFrame: Before the intervention and after 10 days of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Chengguanqu
state: Gansu
Study officials:
References: