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

December 3, 2021 updated by: Yu Qian, Hubei Cancer Hospital

Impact of Baduanjin Qigong Exercise on Fatigue in Patients With Non Small Cell Lung Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Other: Baduanjin, a type of Qigong
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.
Placebo Comparator: Control group
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.
Other: Baduanjin, a type of Qigong
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scale of fatigue
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Cancer Hospital

Investigators

  • Principal Investigator: Yuan Wu, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLHBCH2021YN-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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