Pulmonary Disease, Chronic ObstructiveNCT05986448
Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With AECOPD
A study testing Tai-chi exercise in people with Pulmonary Disease, Chronic Obstructive, run by Houmei SHEN at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the therapeutic effect of Chinese traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with malnutrition. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tai-chi exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 2 Jan 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥60 and ≤85 years of age;
- Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
- Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea;
- NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition;
- Conscious, able to perform normal verbal communication and without motor dysfunction
Who cannot join
- People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment;
- People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation;
- People with impaired motor function;
- People with serious life-threatening diseases of other systems and malignant tumors;
- People with heart failure (NYHA stage IV).
Trial locations and contacts
1 site in 1 country.
China1 site
Anqing Hospital Affiliated to Anhui Medical University
Anqing, Anhui
About this study
Official title: Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and Malnutrition: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn about the therapeutic effect of Chinese traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with malnutrition. The main questions it aims to answer are:
- Improvement of pulmonary function in patients with Tai Chi exercise;
- Improvement of pulmonary function in patients with Tai Chi exercise.
Read more
The patients in control group were given routine nursing care model, including:
- Providing basic nursing care and protection for patients according to their needs, paying attention to the care of patients' airways, and providing relevant protection and auxiliary interventions according to the needs of patients when carrying out nebulized inhalation interventions;
- Customized nutritional supplementation recipes by specialists in clinical nutrition, giving high-protein and low-carbohydrate diets, and giving enteral or parenteral nutritional support to those who have insufficient food intake through the mouth;
- Carrying out health education and psychological care to alleviate the patients' psychological burdens.
On the basis of the routine care model of the control group, a Tai Chi training program was developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai Chi Association were invited to guide the training. The training program consists of a 5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training stretching session. The Tai Chi training was done at a moderate intensity, with the heart rate limited to 60%~80% of the maximal heart rate, where:
maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate changes during training, and when the heart rate exceeded the standard range, the exercise intensity could be adjusted to keep the heart rate within a reasonable range.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tai-chi exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-chi exerciseBehavioural
Traditional Chinese Tai Chi Movement
| Study group | Role | What they receive |
|---|---|---|
| Tai-chi group | Experimental | Basic care measures and Tai-chi exercise Receives: Behavioral: Tai-chi exercise |
| control group | No intervention | Basic care measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
BODE index
Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)
Measured: Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.
Plasma total protein
Measured: Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.
Secondary outcomes (2)
Plasma albumin
Measured: Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
Plasma prealbumin
Measured: Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Feb 2022
- Primary completion1 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Houmei SHEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Houmei SHEN, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986448
- Sponsor's protocol ID
- 2022-35
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and Malnutrition: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05986448
- Acronym / sponsor ID
- 2022-35
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Houmei SHENUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 14 Aug 2023 (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.
The goal of this clinical trial is to learn about the therapeutic effect of Chinese traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with malnutrition. The main questions it aims to answer are:
- Improvement of pulmonary function in patients with Tai Chi exercise;
- Improvement of pulmonary function in patients with Tai Chi exercise.
The patients in control group were given routine nursing care model, including:
- Providing basic nursing care and protection for patients according to their needs, paying attention to the care of patients' airways, and providing relevant protection and auxiliary interventions according to the needs of patients when carrying out nebulized inhalation interventions;
- Customized nutritional supplementation recipes by specialists in clinical nutrition, giving high-protein and low-carbohydrate diets, and giving enteral or parenteral nutritional support to those who have insufficient food intake through the mouth;
- Carrying out health education and psychological care to alleviate the patients' psychological burdens.
On the basis of the routine care model of the control group, a Tai Chi training program was developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai Chi Association were invited to guide the training. The training program consists of a 5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training stretching session. The Tai Chi training was done at a moderate intensity, with the heart rate limited to 60%~80% of the maximal heart rate, where:
maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate changes during training, and when the heart rate exceeded the standard range, the exercise intensity could be adjusted to keep the heart rate within a reasonable range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai-chi group | Experimental | Behavioral: Tai-chi exerciseBasic care measures and Tai-chi exercise |
| control group | No intervention | –Basic care measures |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥60 and ≤85 years of age;
- Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
- Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea;
- NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition;
- Conscious, able to perform normal verbal communication and without motor dysfunction
Key exclusion criteria (5 listed)
- People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment;
- People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation;
- People with impaired motor function;
- People with serious life-threatening diseases of other systems and malignant tumors;
- People with heart failure (NYHA stage IV).
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 |
|---|---|---|
| Tai-chi exerciseTraditional Chinese Tai Chi Movement | Behavioural | Tai-chi group |
Primary outcome
BODE index
Time frame: Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.
Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)
Plasma total protein
Time frame: Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.
2 secondary outcomes
Plasma albumin
Time frame: Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
Plasma prealbumin
Time frame: Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
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 15 Aug 2023.
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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 Tai-chi exercise in people with Pulmonary Disease, Chronic Obstructive, run by Houmei SHEN 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 5 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 15 Aug 2023. 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?
BODE index (time frame: Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.). The study lists 2 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 15 Aug 2023.