Post-cardiac SurgeryNCT05863767
Effects of Baduanjin Sequential Therapy on Post CABG Patients.
A study testing Baduanjin sequential therapy and Conventional Therapy in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients. Many studies have focused on the effects of standing Baduanjin on chronic diseases and it's an evidence-based therapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- Baduanjin sequential therapy and Conventional Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2023to Oct 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT
Who cannot join
- Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Peshawar Institute of cardiology
Peshawar, KPK, 25000
Mehwish Waseem, MSPT(CPPT), 0331-5309015, mehwish.waseem@riphah.edu.pk
Iqra Ayub, MSPT(CPPT*), 0343 5907958, Zartashiaq780@gmail.com
About this study
Official title: Effect of Baduanjin Sequential Therapy on Physical Functioning and Quality of Life Among Post CABG Patients.
To determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients. Many studies have focused on the effects of standing Baduanjin on chronic diseases and it's an evidence-based therapy.
Read the detailed description
There exists limited data from large-scale randomized trials that have addressed the effect of Baduanjin exercise on the quality of life and cardiac function in the patient with CABG. Therefore, this study aims to determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients.
- Conditions
- Post-cardiac Surgery
- Being tested
- Baduanjin sequential therapy, Conventional Therapy
- Keywords
- Baduanjin sequential therapy, CABG, Physical functioning, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin sequential therapyOther
Baduanjin sequential therapy consists of eight different movements including the preparatory phase till final movement (gathering the energy). The session will account for 30 minutes twice a day for four weeks.
Conventional TherapyOther
Neck stretches Arm circles Triceps stretch Calf stretch Forward step up Strengthening exercises Every exercise 5 repetitions three times a day
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Baduanjin sequential therapy consists of Six different movements including the preparatory phase. The session will account for 30 minutes twice a day for four weeks. Receives: Other: Baduanjin sequential therapy |
| Control group | Placebo comparator | Control intervention: AROM, Breathing exercises, and stretches 5 repetitions three times a day. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Changes from baseline to 4 weeks, measured through 6 min walk test (6 MWT) used to measure Functional capacity. It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Measured: 4 weeks
Functional performance
Changes from baseline to 4 weeks, measured through Short physical performance battery. It is a commonly used tool in clinical setting for measuring the physical performance of patients. It is divided into three subtests: balance, a short walk at normal pace and lastly standing up from a chair five times repeatedly. These subsets exemplify core tasks being important for independent living. Scoring of each test range from s 0 (worst performance) to 4 (best performance). The sum total for the entire battery is between 0 to 12 which is the sum of all 3 tests. The cutoff point is 10 or lower for mobility impairment. Low scores on shows health consequences related with disability in Activities of Daily Living.
Measured: 4 weeks
Health related Quality of Life (QOL)
Changes from baseline to 4 weeks, measured through Short Form 36 Health Survey Questionnaire (SF-36) that is used to indicate the health status of a particular population. This tool consists of eight domains comprising functional capability, role physical functioning, role emotional functioning, psychological state, liveliness, social affairs, bodily pain, and overall health. Responses are marked on a Likert scale comprising of 5 points and then converted on a scale of 100. Attaining scores more than 50 indicated a better state of health and the lower score the more disability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start5 Apr 2023
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863767
- Sponsor's protocol ID
- REC/01387 Iqra Ayub
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao S, Zhang X, Chen M, Wang C, Chen Q, Guo L, Zhang M, Hinek A. Beneficial Effects of Baduanjin Exercise on Left Ventricular Remodelling in Patients after Acute Myocardial Infarction: an Exploratory Clinical Trial and Proteomic Analysis. Cardiovasc Drugs Ther. 2021 Feb;35(1):21-32. doi: 10.1007/s10557-020-07047-0. Epub 2020 Aug 6.
PubMed 32761487Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.
PubMed 32714423Chen DM, Yu WC, Hung HF, Tsai JC, Wu HY, Chiou AF. The effects of Baduanjin exercise on fatigue and quality of life in patients with heart failure: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Jun;17(5):456-466. doi: 10.1177/1474515117744770. Epub 2017 Nov 30.
PubMed 29189045
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baduanjin Sequential Therapy on Physical Functioning and Quality of Life Among Post CABG Patients.
- ClinicalTrials.gov ID
- NCT05863767
- Acronym / sponsor ID
- REC/01387 Iqra Ayub
- Conditions
- Post-cardiac Surgery
- Keywords
- Baduanjin sequential therapy, CABG, Physical functioning, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 May 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.
To determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients. Many studies have focused on the effects of standing Baduanjin on chronic diseases and it's an evidence-based therapy.
Detailed description
There exists limited data from large-scale randomized trials that have addressed the effect of Baduanjin exercise on the quality of life and cardiac function in the patient with CABG. Therefore, this study aims to determine the effects of Baduanjin sequential therapy (BST) on physical functioning and quality of life among post-CABG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Baduanjin sequential therapyBaduanjin sequential therapy consists of Six different movements including the preparatory phase. The session will account for 30 minutes twice a day for four weeks. |
| Control group | Placebo comparator | Other: Conventional TherapyControl intervention: AROM, Breathing exercises, and stretches 5 repetitions three times a day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT
Key exclusion criteria (1 listed)
- Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent
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 |
|---|---|---|
| Baduanjin sequential therapyBaduanjin sequential therapy consists of eight different movements including the preparatory phase till final movement (gathering the energy). The session will account for 30 minutes twice a day for four weeks. | Other | Interventional Group |
| Conventional TherapyNeck stretches Arm circles Triceps stretch Calf stretch Forward step up Strengthening exercises Every exercise 5 repetitions three times a day | Other | Control group |
Primary outcome
Functional capacity
Time frame: 4 weeks
Changes from baseline to 4 weeks, measured through 6 min walk test (6 MWT) used to measure Functional capacity. It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Functional performance
Time frame: 4 weeks
Changes from baseline to 4 weeks, measured through Short physical performance battery. It is a commonly used tool in clinical setting for measuring the physical performance of patients. It is divided into three subtests: balance, a short walk at normal pace and lastly standing up from a chair five times repeatedly. These subsets exemplify core tasks being important for independent living. Scoring of each test range from s 0 (worst performance) to 4 (best performance). The sum total for the entire battery is between 0 to 12 which is the sum of all 3 tests. The cutoff point is 10 or lower for mobility impairment. Low scores on shows health consequences related with disability in Activities of Daily Living.
Health related Quality of Life (QOL)
Time frame: 4 weeks
Changes from baseline to 4 weeks, measured through Short Form 36 Health Survey Questionnaire (SF-36) that is used to indicate the health status of a particular population. This tool consists of eight domains comprising functional capability, role physical functioning, role emotional functioning, psychological state, liveliness, social affairs, bodily pain, and overall health. Responses are marked on a Likert scale comprising of 5 points and then converted on a scale of 100. Attaining scores more than 50 indicated a better state of health and the lower score the more disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 32761487Mao S, Zhang X, Chen M, Wang C, Chen Q, Guo L, Zhang M, Hinek A. Beneficial Effects of Baduanjin Exercise on Left Ventricular Remodelling in Patients after Acute Myocardial Infarction: an Exploratory Clinical Trial and Proteomic Analysis. Cardiovasc Drugs Ther. 2021 Feb;35(1):21-32. doi: 10.1007/s10557-020-07047-0. Epub 2020 Aug 6.
- Background: PubMed 32714423Chen MG, Liang X, Kong L, Wang J, Wang F, Hu X, He J, Zeng RX, Mao S, Guo L, Zhang MZ, Zhang X. Effect of Baduanjin Sequential Therapy on the Quality of Life and Cardiac Function in Patients with AMI After PCI: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Jul 4;2020:8171549. doi: 10.1155/2020/8171549. eCollection 2020.
- Background: PubMed 29189045Chen DM, Yu WC, Hung HF, Tsai JC, Wu HY, Chiou AF. The effects of Baduanjin exercise on fatigue and quality of life in patients with heart failure: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Jun;17(5):456-466. doi: 10.1177/1474515117744770. Epub 2017 Nov 30.
- Individual participant dataSharing planned: No
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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.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin sequential therapy and Conventional Therapy in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 May 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehwish Waseem, MSPT(CPPT) (0331-5309015, mehwish.waseem@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863767, which also lists 3 linked publications.
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 18 May 2023.