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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863767
Other study ID # REC/01387 Iqra Ayub
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2023
Est. completion date October 2023

Study information

Verified date May 2023
Source Riphah International University
Contact Mehwish Waseem, MSPT(CPPT)
Phone 0331-5309015
Email mehwish.waseem@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT Exclusion Criteria: - Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Baduanjin sequential therapy
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 Therapy
Neck stretches Arm circles Triceps stretch Calf stretch Forward step up Strengthening exercises Every exercise 5 repetitions three times a day

Locations

Country Name City State
Pakistan Peshawar Institute of cardiology Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Chen 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. — View Citation

Chen 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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. 4 weeks
Primary 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. 4 weeks
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