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

NCT04670367 | Unknown

• 1 other identifier: TCU-CHHuang-BaduanjinHeart
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open Heart Surgery

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Arm A: usual care

PLACEBO COMPARATOR

routine usual care

Other: usual care

Arm B: walk

EXPERIMENTAL

walk 30mins per day, 5 days per week.

Behavioral: Walk 30mins

Arm C: Baduanjin

EXPERIMENTAL

Baduanjin 12 mins per day, 5 days per week.

Behavioral: Baduanjin

Arm D: Baduanjin plus walk

EXPERIMENTAL

walk 30mins then Baduanjin 12 mins per day, 5 days per week.

Behavioral: Walk plus Baduanjin

Interventions

Walk 30mins BEHAVIORAL

aerobic exercise

Arm B: walk

Walk plus Baduanjin BEHAVIORAL

Walk 30mins then Baduanjin 12mins per day, 5 times per week.

Arm D: Baduanjin plus walk

usual care OTHER

routine care

Arm A: usual care

Baduanjin BEHAVIORAL

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

Arm C: Baduanjin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzu Chi University: lead

Study Sites (1)

Tzu Chi University

Hualien City, 90093, Taiwan

RECRUITING

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Chu Hou Huang, PhD

CONTACT

886-3-565301; hou2017@gms.tcu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance Professor

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 17, 2020
• Study Start: November 26, 2020
• Primary Completion: May 27, 2021
• Study Completion: November 27, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)