Baduanjin Exercise on Meridian Energy, Lung Function and Heart Rate Variability in Patients Undergoing Lung Operative.

Baduanjin Exercise on Lung Operative

Lung cancer (LC) is the leading cause of cancer-related death and is the most frequent cancer in both sexes.Respectable lung tumor with abnormal lung function, usually because of tobacco use, have chronic obstructive pulmonary disease (COPD), coronary artery disease, and/or old age as underlying comorbidities. Until recent, most exercise prescribed using aerobic exercise programs. 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. The impacts of a Baduanjin exercise-based cardiopulmonary rehabilitation program for patients recovering from respectable lung tumor on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan), lung function and heart rate variability has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective lung function, meridian energy and HRV in patients following lung operative.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer Non Small Cell
• Intervention / Treatment: Other: usual care; Behavioral: Walk; Behavioral: Baduanjin; Behavioral: Baduanjin plus walk

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

Contacts and Locations

• Study Contact: Name: Chun Hou Huang, PhD; Phone Number: 2227 886-3-8565301; Email: hou2017@gms.tcu.edu.tw

Study Locations

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

• Diagnosis of primary NSCLC based on preoperative pathologic examination
• Had no surgical contraindication to and were willing to undergo video-assisted thoracic surgery or traditional thoracotomy (open) lobectomy
• Agreed to receive exercise performed.

Exclusion Criteria:

• SpO2 <90% during the 6-min walking test
• With an absence of NSCLC, as confirmed by postoperative pathologic examination or with sub-lobar resection or pneumonectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• 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
ACTIVE_COMPARATOR: Arm B: walk; Walk 30mins per day, 5 days per week.	Behavioral: Walk; Walk 30mins
ACTIVE_COMPARATOR: 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: Baduanjin plus walk; 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 24 points skin electric conductance over bilateral wrist and foot in patients undergoing lung operative, after admission baseline evaluation before lung operative 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 lung operative 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 lung operative 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 lung operative 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 lung operative 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
• Investigators: Principal Investigator: Chun Hou Huang, PhD, 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 14, 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 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TCU-CHHuang-BaduanjinLungCa

Drug and device information, study documents

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