The Effects of Baduanjin Exercise on Meridian Energy and Heart Rate Variability in Patients Undergoing Cardiac Sugery

Baduanjin Exercise on Cardiac Surgery

Cardiac rehabilitation (CR) consists of supervised exercise training in conjunction with other secondary prevention interventions. However, CR is not widely used because of distance, financial resources, work and other time constraints, gender, age, social support, illness perceptions, and psychiatric problems. Baduanjin is a type of movement-based mind-body intervention. It is a form of traditional practice designed to promote physical and psychological health, manage symptoms, and relieve stress during illness. Patients with heart disease have frequently used it. The impacts of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from CAD under coronary artery bypass graft (CABG) or valve replacement on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) and heart rate variability (HRV) has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective meridian energy and HRV in patients following CABG.

Study Overview

• Status: Unknown
• Conditions: Open Heart Surgery
• Intervention / Treatment: Behavioral: Baduanjin; Other: usual care; Behavioral: Walk 30mins; Behavioral: Walk plus Baduanjin

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan, 90093
    • Recruiting
    • Tzu Chi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 25-70 age range
• Undergoing open heart surgery
• Hemodynamically stable
• Ambulatory
• No advanced vision defect
• The physician authorized by the operating physician for participation in the exercise
• Patients who agreed to participate in the study.

Exclusion Criteria:

• The presence of pulmonary, neurological, musculoskeletal disease limiting participation in exercise training
• Patients at high risk (ejection fraction below 40 percent)
• Dissectant aneurysm
• Patients who cannot be cooperative in verbal and / or auditory terms
• Psychological and / or perceptual cooperative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm A: usual care; routine usual care	Other: usual care; routine care
Experimental: Arm B: walk; walk 30mins per day, 5 days per week.	Behavioral: Walk 30mins; aerobic exercise
Experimental: Arm C: Baduanjin; Baduanjin 12 mins per day, 5 days per week.	Behavioral: Baduanjin; Baduanjin exercise is moderate in intensity and short in duration (a set of Baduanjin takes about 12 minutes). Baduanjin consists of the sitting and standing practicing form. The sitting Baduanjin exercise conforms to the aspects of low-intensity and long-term aerobic activity, which is suitable for the rehabilitation training of patients who are in stable condition during hospitalization. The standing Baduanjin is more suitable for patients with sequential rehabilitation after discharge and can be adjusted based on the patient's condition
Experimental: Arm D: Baduanjin plus walk; walk 30mins then Baduanjin 12 mins per day, 5 days per week.	Behavioral: Walk plus Baduanjin; Walk 30mins then Baduanjin 12mins per day, 5 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)：Baseline	The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.	Baseline
The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 2 weeks	The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.	2 weeks
The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 4 weeks	The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.	4 weeks
The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 12 weeks	The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.	12 weeks
The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 16 weeks	The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.	16 weeks

Collaborators and Investigators

• Sponsor: Tzu Chi University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Anticipated): May 27, 2021
• Study Completion (Anticipated): November 27, 2022

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TCU-CHHuang-BaduanjinHeart

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