ConstipationNCT06401460
Yannianjiuzhuan Method and Reverse Breathing Training to Improve Constipation in Elderly Patients With Coronary Heart Disease
A study testing Yannianjiuzhuan method combined with reverse breathing training in people with Constipation and Coronary Heart Disease, run by Junfang Miao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Constipation, Coronary Heart Disease
- What is being tested?
- Yannianjiuzhuan method combined with reverse breathing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for chronic stable coronary heart disease and constipation .
- Aged 60 years and above but below 80 years.
- Heart function classified as ≤ Class 2.
- Clear consciousness, no language barriers, free of dementia or psychiatric history, and willing to comply with treatment.
- Voluntarily participating in the study and has signed the informed consent form.
Who cannot join
- Patients participating in other trials that could affect the results of this study.
- Patients with organic constipation, refractory constipation, or fecal incontinence.
- Patients with significant physical mobility impairments.
- Patients suffering from severe metabolic diseases, cardiopulmonary diseases, hematological diseases, or psychiatric disorders.
- Patients who have undergone abdominal surgery or other conditions unsuitable for abdominal massage within the past six months.
- Patients who have taken medications affecting digestive functions and bowel movement in the past week.
- Patients who underwent lumbar surgery within the past six months.
- Patients assessed by doctors as having severe constipation symptoms, which could potentially worsen their condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gansu University of Chinese Medicine
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.
Read more
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.
- Conditions
- Constipation, Coronary Heart Disease
- Being tested
- Yannianjiuzhuan method combined with reverse breathing training
- Medical subject headings
- Constipation, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yannianjiuzhuan method combined with reverse breathing trainingOther
Timing of Operations
- Reverse Abdominal Breathing: Performed from 9:00 AM to 11:00 AM and from 7:00 PM to 9:00 PM daily, one inhalation and one exhalation constituting one cycle, with 30 cycles per training session, twice a day, over a period of ten days.
- Yannian Jiuzhuan Method: Conducted daily from 7:00 AM to 9:00 AM and from 9:00 PM to 11:00 PM, twice a day, for a duration of ten days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Yannianjiuzhuan method combined with reverse breathing training. Receives: Other: Yannianjiuzhuan method combined with reverse breathing training |
| Control group | Experimental | The control group received standard care in accordance with the "Constipation Nursing Protocol for Cardiology Patients," which included basic care, disease education, dietary and exercise guidance, bowel movement and psychological counseling . Receives: Other: Yannianjiuzhuan method combined with reverse breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC-SYM
Patient Assessment of Constipation Symptoms (PAC-SYM) : This scale assesses the clinical presentation and severity of constipation across three dimensions: abdominal, rectal, and stool symptoms, with a total of 12 items. Using a Likert 5-point scoring system, higher scores indicate more severe symptoms.
Measured: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
Bristol Stool Scale
Bristol Stool Scale: This scale is used to evaluate the characteristics of stool, with seven types ranked; lower scores denote harder stools, indicating more severe constipation.
Measured: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
SAS
Self-Rating Anxiety Scale (SAS) : This scale is applicable to a broad population and assesses 20 items including anxiety and fear, using a Likert 4-point scoring system. Higher scores reflect greater anxiety levels.
Measured: Before the intervention and after 10 days of intervention.
PSQI
Pittsburgh Sleep Quality Index (PSQI) : This index evaluates patient sleep quality across 24 items spanning seven dimensions. Higher scores indicate more severe sleep quality issues.
Measured: Before the intervention and after 10 days of intervention.
PAC-QoL
Patient Assessment of Constipation Quality of Life (PAC-QoL) : Encompassing 28 items, this scale covers the dimensions of worry/concern, physical discomfort, psychosocial impacts, and satisfaction. Higher scores suggest greater impact on patients' quality of life.
Measured: Before the intervention and after 10 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Nov 2021
- Primary completion1 Jan 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junfang Miao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junfang Miao, Gansu University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401460
- Sponsor's protocol ID
- 1774164090@qq.com
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gansu University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT06401460
- Acronym / sponsor ID
- 1774164090@qq.com
- Conditions
- Constipation, Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Junfang MiaoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Yannianjiuzhuan method combined with reverse breathing trainingYannianjiuzhuan method combined with reverse breathing training. |
| Control group | Experimental | Other: Yannianjiuzhuan method combined with reverse breathing trainingThe control group received standard care in accordance with the "Constipation Nursing Protocol for Cardiology Patients," which included basic care, disease education, dietary and exercise guidance, bowel movement and psychological counseling . |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the diagnostic criteria for chronic stable coronary heart disease and constipation .
- Aged 60 years and above but below 80 years.
- Heart function classified as ≤ Class 2.
- Clear consciousness, no language barriers, free of dementia or psychiatric history, and willing to comply with treatment.
- Voluntarily participating in the study and has signed the informed consent form.
Key exclusion criteria (8 listed)
- Patients participating in other trials that could affect the results of this study.
- Patients with organic constipation, refractory constipation, or fecal incontinence.
- Patients with significant physical mobility impairments.
- Patients suffering from severe metabolic diseases, cardiopulmonary diseases, hematological diseases, or psychiatric disorders.
- Patients who have undergone abdominal surgery or other conditions unsuitable for abdominal massage within the past six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yannianjiuzhuan method combined with reverse breathing trainingTiming of Operations 1. Reverse Abdominal Breathing: Performed from 9:00 AM to 11:00 AM and from 7:00 PM to 9:00 PM daily, one inhalation and one exhalation constituting one cycle, with 30 cycles per training session, twice a day, over a period of ten days. 2. Yannian Jiuzhuan Method: Conducted daily from 7:00 AM to 9:00 AM and from 9:00 PM to 11:00 PM, twice a day, for a duration of ten days. | Other | Control group, Experimental group |
Primary outcome
PAC-SYM
Time frame: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
Patient Assessment of Constipation Symptoms (PAC-SYM) : This scale assesses the clinical presentation and severity of constipation across three dimensions: abdominal, rectal, and stool symptoms, with a total of 12 items. Using a Likert 5-point scoring system, higher scores indicate more severe symptoms.
Bristol Stool Scale
Time frame: Before the intervention，after 3 days of intervention，and after 10 days of intervention.
Bristol Stool Scale: This scale is used to evaluate the characteristics of stool, with seven types ranked; lower scores denote harder stools, indicating more severe constipation.
SAS
Time frame: Before the intervention and after 10 days of intervention.
Self-Rating Anxiety Scale (SAS) : This scale is applicable to a broad population and assesses 20 items including anxiety and fear, using a Likert 4-point scoring system. Higher scores reflect greater anxiety levels.
PSQI
Time frame: Before the intervention and after 10 days of intervention.
Pittsburgh Sleep Quality Index (PSQI) : This index evaluates patient sleep quality across 24 items spanning seven dimensions. Higher scores indicate more severe sleep quality issues.
PAC-QoL
Time frame: Before the intervention and after 10 days of intervention.
Patient Assessment of Constipation Quality of Life (PAC-QoL) : Encompassing 28 items, this scale covers the dimensions of worry/concern, physical discomfort, psychosocial impacts, and satisfaction. Higher scores suggest greater impact on patients' quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yannianjiuzhuan method combined with reverse breathing training in people with Constipation and Coronary Heart Disease, run by Junfang Miao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAC-SYM (time frame: Before the intervention，after 3 days of intervention，and after 10 days of intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.