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Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy

Primary Purpose

Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin, a type of Qigong
Sponsored by
Hubei Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • This trial aims to enroll 18- to 75-year-old patients expected to survive > 3 months and with a Zubrod performance status of 0 to 2. All patients must have diagnosed as lung cancer and have at least one cycle of adjuvant chemotherapy. Enrolled patients should have a minimal ESAS fatigue as 3. Other inclusion criteria are lack of leptomeningeal disease, adequate hepatorenal function and blood counts (red blood cells, >3.0 * 1012/L; white blood cells, > 3.5 * 109/L; absolute neutrophil count, > 1.5 * 109/L; platelets, > 100 * 109/L; hemoglobin > 90 g/L).

Exclusion Criteria:

  • Children

Sites / Locations

  • Hubei Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Participants in the intervention group received two months of Baduanjin exercise training provided by the specialist coach 3 days per week in Hubei Cancer Hospital, and they were also required to do Baduanjin exercise at home for the remaining 4 days each week for at least 20 min per day. All the participants are requested to monitor and record adverse effects during their exercise sessions.

Participants in the control group were requested to maintain their original daily physical activity for no less than 20 min per day over the following 6-month period and record their daily activity at home by themselves. These data were collected by a researcher during the participants' time in the study and at the 6-month follow-up at the hospital. After the 6-month follow-up, the participants were provided with 1-month professional Baduanjin exercise guidance by the trial's specialist coach for free if they wished.

Outcomes

Primary Outcome Measures

Scale of fatigue

Secondary Outcome Measures

Full Information

First Posted
December 1, 2021
Last Updated
December 3, 2021
Sponsor
Hubei Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05159167
Brief Title
Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy
Official Title
Impact of Baduanjin Qigong Exercise on Fatigue in Patients With Non Small Cell Lung Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Cancer Hospital

4. Oversight

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

5. Study Description

Brief Summary
Baduanjin,a type of Qigong which belongs to aerobic exercise, is very popular in China. There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders. In college students, it may enhance cardio respiratory function, lower limb function, and flexibility compared with usual exercise. However, there is no previous relevant randomized controlled trials on the health promoting effects of Baduanjin exercise in targeted fatigued lung cancer patients. Lung cancer survivors can experience fatigue due to multiple reasons that can strongly impact their quality of life throughout the remainder of their life. Therefore, this randomized controlled trial in China was designed to assess the health promoting effects of Baduanjin exercise in fatigued lung cancer patients with the expectation of improvement in physical and psychological health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group received two months of Baduanjin exercise training provided by the specialist coach 3 days per week in Hubei Cancer Hospital, and they were also required to do Baduanjin exercise at home for the remaining 4 days each week for at least 20 min per day. All the participants are requested to monitor and record adverse effects during their exercise sessions.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in the control group were requested to maintain their original daily physical activity for no less than 20 min per day over the following 6-month period and record their daily activity at home by themselves. These data were collected by a researcher during the participants' time in the study and at the 6-month follow-up at the hospital. After the 6-month follow-up, the participants were provided with 1-month professional Baduanjin exercise guidance by the trial's specialist coach for free if they wished.
Intervention Type
Other
Intervention Name(s)
Baduanjin, a type of Qigong
Intervention Description
Baduanjin is very popular in China. There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders.
Primary Outcome Measure Information:
Title
Scale of fatigue
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This trial aims to enroll 18- to 75-year-old patients expected to survive > 3 months and with a Zubrod performance status of 0 to 2. All patients must have diagnosed as lung cancer and have at least one cycle of adjuvant chemotherapy. Enrolled patients should have a minimal ESAS fatigue as 3. Other inclusion criteria are lack of leptomeningeal disease, adequate hepatorenal function and blood counts (red blood cells, >3.0 * 1012/L; white blood cells, > 3.5 * 109/L; absolute neutrophil count, > 1.5 * 109/L; platelets, > 100 * 109/L; hemoglobin > 90 g/L). Exclusion Criteria: Children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Qian, Dr
Phone
+862787670255
Email
173653835@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Wu
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Wu, Dr.
Phone
027-87670318
Email
gwgfe@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy

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