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

NCT04669730 | Unknown

• 1 other identifier: TCU-CHHuang-BaduanjinLungCa
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer Non Small Cell

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Arm A: usual care

PLACEBO COMPARATOR

Routine usual care

Other: usual care

Arm B: walk

ACTIVE COMPARATOR

Walk 30mins per day, 5 days per week.

Behavioral: Walk

Arm C: Baduanjin

ACTIVE COMPARATOR

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: Baduanjin plus walk

Interventions

usual care OTHER

Routine care

Arm A: usual care

Walk BEHAVIORAL

Walk 30mins

Arm B: walk

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

Baduanjin plus walk BEHAVIORAL

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

Arm D: Baduanjin plus walk

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzu Chi University: lead

Study Sites (2)

Tzu Chi University

Hualien City, 90093, Taiwan

RECRUITING

Tzu Chi University

Hualien City, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Walking

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chun Hou Huang, PhD

  Tzu Chi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Hou Huang, PhD

CONTACT

886-3-8565301; hou2017@gms.tcu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• 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

Locations

TW (2)