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

Primary Purpose

Lung Cancer Non Small Cell

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
usual care
Walk
Baduanjin
Baduanjin plus walk
Sponsored by
Tzu Chi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer Non Small Cell

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tzu Chi UniversityRecruiting
  • Tzu Chi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

Arm A: usual care

Arm B: walk

Arm C: Baduanjin

Arm D: Baduanjin plus walk

Arm Description

Routine usual care

Walk 30mins per day, 5 days per week.

Baduanjin 12 mins per day, 5 days per week.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2020
Last Updated
December 14, 2020
Sponsor
Tzu Chi University
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1. Study Identification

Unique Protocol Identification Number
NCT04669730
Brief Title
Baduanjin Exercise on Meridian Energy, Lung Function and Heart Rate Variability in Patients Undergoing Lung Operative.
Official Title
Baduanjin Exercise on Lung Operative
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
May 27, 2021 (Anticipated)
Study Completion Date
November 27, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tzu Chi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Non Small Cell

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: usual care
Arm Type
Placebo Comparator
Arm Description
Routine usual care
Arm Title
Arm B: walk
Arm Type
Active Comparator
Arm Description
Walk 30mins per day, 5 days per week.
Arm Title
Arm C: Baduanjin
Arm Type
Active Comparator
Arm Description
Baduanjin 12 mins per day, 5 days per week.
Arm Title
Arm D: Baduanjin plus walk
Arm Type
Experimental
Arm Description
Walk 30mins then Baduanjin 12 mins per day, 5 days per week.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Routine care
Intervention Type
Behavioral
Intervention Name(s)
Walk
Intervention Description
Walk 30mins
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin plus walk
Intervention Description
Walk 30mins then Baduanjin 12mins per day, 5 times per week.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline
Title
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
Description
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.
Time Frame
2 weeks
Title
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
Description
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.
Time Frame
4 weeks
Title
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
Description
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.
Time Frame
12 weeks
Title
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
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Hou Huang, PhD
Phone
886-3-8565301
Ext
2227
Email
hou2017@gms.tcu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Hou Huang, PhD
Organizational Affiliation
Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tzu Chi University
City
Hualien City
ZIP/Postal Code
90093
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Hou Huang, Phd
Phone
886-978650985
Email
hou2017@gms.tcu.edu.tw
Facility Name
Tzu Chi University
City
Hualien City
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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