Effects of Baduanjin Sequential Therapy on Post CABG Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Post-cardiac Surgery
• Intervention / Treatment: Other: Baduanjin sequential therapy; Other: Conventional 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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehwish Waseem, MSPT(CPPT); Phone Number: 0331-5309015; Email: mehwish.waseem@riphah.edu.pk

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Recruiting
      • Peshawar Institute of Cardiology
      • Contact: Mehwish Waseem, MSPT(CPPT); Phone Number: 0331-5309015; Email: mehwish.waseem@riphah.edu.pk
      • Contact: Iqra Ayub, MSPT(CPPT*); Phone Number: 0343 5907958; Email: Zartashiaq780@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; 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.	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.
Placebo Comparator: Control group; Control intervention: AROM, Breathing exercises, and stretches 5 repetitions three times a day.	Other: Conventional Therapy; Neck stretches Arm circles Triceps stretch Calf stretch Forward step up Strengthening exercises Every exercise 5 repetitions three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; CABG; Physical functioning; Baduanjin sequential therapy
• Other Study ID Numbers: REC/01387 Iqra Ayub

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No