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Trial registered on ANZCTR


Registration number
ACTRN12624001037594
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Qigong Plus: Feasibility of delivering Qigong online to address social connection and wellbeing for the vulnerable in our community
Scientific title
Qigong Plus: Feasibility of delivering Qigong online to address social connection and wellbeing for older adults aged 60 years and over living in the community
Secondary ID [1] 312699 0
None
Universal Trial Number (UTN)


Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Ageing in Older Adults 334766 0
Condition category
Condition code
Public Health 331327 331327 0 0
Other public health
Physical Medicine / Rehabilitation 331328 331328 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Qigong Plus (QGP) is a 6-week digital Qigong program for older adults living within the community. The program consisted of delivering an online group Qigong session once per week for one-hour guided in realtime by a qualified Qigong instructor. The weekly live sessions were delivered online via ZOOM videoconferencing platform to participants utilising their personal devices (e.g mobile phones, tablets, computers, etc.). After each week, participants were also given access to the ZOOM recordings of the Qigong practice for self-practice.

Program attendance tracking:
The target attendance for program completion was 5 out of 6 online Qigong Plus sessions. Online session attendance was manually recorded by the QGP instructor. Participants were also encouraged to journal their self-practice frequency outside of the online Qigong Plus sessions.

QGP Session structure:
The physical activity component of QGP was primarily in the form of Qigong exercises, which are generally considered to be low-intensity and well-tolerated amongst older adults. Thus, the exercise intensity for the QGP program was considered low - moderate for older adults. In addition, the QGP program was designed to allow participants to practice in sitting or standing positions - allowing for participants to opt for sitting practice if they perceived the training intensity to be too difficult. Participants were also encouraged to provide feedback regarding the training intensity for the QGP instructor to adjust the program accordingly.

Please refer to the following example of a 60min QGP online session structure:
Arrivals & Greetings - 5mins
Warm-up exercises (i.e dynamic stretching exercises such as neck and shoulder rotations, etc.)- 15mins
Breath and Chi regulation exercises (e.g exercises include "Lotus Flower Opening", "Two hands hold up the heaven", "Cloud hands", "The Archer Draws the Bow", "Circling the Moon", "Parting the Wild Horse's Mane".) - 15-20mins
Cool Down exercises -5-10mins
Mindfulness exercises - 10mins

Procedures: Participants were recruited within Australia. The QGP program took place primarily online. The QGP sessions were led by a Qualified Qigong master instructor experienced in the delivery of online and in-person Qigong programs. Once a week, for 6 weeks, participants attended an online group Qigong session led by the Qigong instructor. Participants also attended a 30-minute online orientation session one week before QGP program commencement via ZOOM, where they met with the Qigong instructor. The orientation session introduced participants to the program and helped them familirise themselves with the procedures for participating in the QGP program. Subsequently, each QGP online session was 60-minutes, consisting of 45-minutes Qigong practice, followed by 15-minutes of meditation for self-awareness and reflection. Examples of Qigong exercises included were “Lotus Flower Opening", "Two hands hold up the heaven", "Cloud hands", "The Archer Draws the Bow", "Circling the Moon", "Parting the Wild Horse's Mane". Qigong exercises were also adapted to better suit older adults (e.g minimising Qigong stances that require balancing on a single foot, etc.) In addition, participants were given access to ZOOM recordings of the Qigong sessions. The Qigong recordings were edited to focus on the program delivery of the Qigong instructor and removed the screens of the participants. Access to each session recording was only provided after completion of the respective weekly session.
Intervention code [1] 329277 0
Lifestyle
Intervention code [2] 329278 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339102 0
Engagement Facilitators and Barriers
Timepoint [1] 339102 0
Baseline, end of program (Week 6, primary timepoint)
Primary outcome [2] 339103 0
Safety
Timepoint [2] 339103 0
Baseline, end of program (Week 6, primary timepoint)
Primary outcome [3] 339104 0
Acceptability
Timepoint [3] 339104 0
Baseline, end of program (Week 6, primary timepoint)
Secondary outcome [1] 438562 0
Barriers to Technology Usage (This is an additional primary outcome)
Timepoint [1] 438562 0
Baseline, mid-program (3rd week), end of program (Week 6, primary timepoint)

Eligibility
Key inclusion criteria
Older adults who fulfil the following criteria:
I. 60 years old and above
II. Living within the community
III. Had access to the internet.
IV. Had access to a device (mobile, tablet, laptop, etc.) to participate in program.
V. Must have been able to perform basic limb movements in either sitting or standing positions.
VI. Must not have had severe visual, hearing, and /or cognitive impairments.
VII. Able to communicate in basic English.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who had undertaken Qigong practice within the past 1 year of their date of recruitment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/04/2022
Date of last participant enrolment
Anticipated
Actual
4/10/2022
Date of last data collection
Anticipated
Actual
7/12/2022
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317132 0
University
Name [1] 317132 0
RMIT University - ECP COVID Restart: ReStart - A Healthier Start
Country [1] 317132 0
Australia
Primary sponsor type
University
Name
RMIT UNIVERSITY
Address
Country
Australia
Secondary sponsor category [1] 319399 0
None
Name [1] 319399 0
Address [1] 319399 0
Country [1] 319399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315884 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 315884 0
Ethics committee country [1] 315884 0
Australia
Date submitted for ethics approval [1] 315884 0
25/10/2021
Approval date [1] 315884 0
22/12/2021
Ethics approval number [1] 315884 0
2022-24895-18321

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136090 0
Prof Zhen Zheng
Address 136090 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 136090 0
Australia
Phone 136090 0
+61 3 9925 7167
Fax 136090 0
Email 136090 0
zhen.zheng@rmit.edu.au
Contact person for public queries
Name 136091 0
Zhen Zheng
Address 136091 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 136091 0
Australia
Phone 136091 0
+61 3 9925 7167
Fax 136091 0
Email 136091 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 136092 0
Zhen Zheng
Address 136092 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 136092 0
Australia
Phone 136092 0
+61 3 9925 7167
Fax 136092 0
Email 136092 0
zhen.zheng@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.