NCT05863767

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 12, 2023

Last Update Submit

May 17, 2023

Conditions

Keywords

Baduanjin sequential therapyCABGPhysical functioningQuality of life

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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.

Other: Baduanjin sequential therapy

Control group

PLACEBO COMPARATOR

Control intervention: AROM, Breathing exercises, and stretches 5 repetitions three times a day.

Other: Conventional Therapy

Interventions

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.

Interventional Group

Neck stretches Arm circles Triceps stretch Calf stretch Forward step up Strengthening exercises Every exercise 5 repetitions three times a day

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Vitally Open heart surgery patients Discharged from the hospital and enrolled as outpatient Able to perform 6MWT

You may not qualify if:

  • Prolonged intubation Unstable vitals Patient needs maximum assistance for mobility Decline consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peshawar Institute of cardiology

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32761487BACKGROUND
  • 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.

    PMID: 32714423BACKGROUND
  • 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.

    PMID: 29189045BACKGROUND

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehwish Waseem, MSPT(CPPT)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 18, 2023

Study Start

April 5, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations