NCT05159167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

December 1, 2021

Last Update Submit

December 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scale of fatigue

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

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.

Control groupIntervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuan Wu

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 1, 2021

First Posted

December 16, 2021

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations