Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000774527
Ethics application status
Approved
Date submitted
17/11/2023
Date registered
25/06/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Adherence to an Online Qigong Program for Older Adults Living Within the Community.
Scientific title
Investigating Adherence to an Online Qigong Program to enhance well-being for Older Adults Living Within the Community.
Secondary ID [1] 310974 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Ageing in Older Adults 332060 0
Condition category
Condition code
Public Health 328787 328787 0 0
Other public health
Physical Medicine / Rehabilitation 330684 330684 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Qigong Plus (QGP) is a 12-week digital Qigong program for older adults living within the community. The program consists of two components for delivering Qigong: (1) Once per week, one-hour online Qigong group classes guided in realtime by a qualified Qigong instructor, and (2) Supplementary pre-recorded 15 - 30min instructor guided QIgong videos provided to participants every week for self-practice. The weekly live sessions will be delivered online via Microsoft TEAMS videoconfernecing platform to participants utilising their personal devices (e.g mobile phones, tablets, computers, etc.).For the offline Qigong recordings, participants are provided access to the web-based exercise prescription platform, Physitrack, where they will recieve weekly Qigong programs for self-practice at the start of every week with the exception of the first week, whereby the Qigong recordings are only provided after participants have attended their first online session.

Program attendance tracking:
The target attendance for program completion will be 9 out of 12 sessions (75%) for participants regarding the online QGP component. There are no specific targets for self-practice, but participants are recommended to engage in at least 15-30mins of self-practice at least twice a week, gradually increasing their frequency of practice to three times a week by the end of the 12-week program. Online session attendance will be manually recorded by the QGP instructor. Offline self-practice sessions will be tracked by (1) The Physitrack platform automated user tracking, and (2) Self-recorded by participants in the form of exercise journals, and (3) Manually indicating the amount of exercises completed when prompted on Physitrack after the completion of each self-practice session

QGP Session structure:
The physical activity component of QGP will be 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 will be considered low - moderate for older adults. In addition, the QGP program is designed to allow participants to practice in sitting or standing positions - allowing for participants to opt for sitting practice if they percieve the training intensity to be too difficult. Participants are also encouraged to provide feedback regarding the training intensity for the QGP instructor to adjust the program accordingly. The QGP instructor will record such feedback from participants for the research team's reference. Offline session structure follows the general structure of the online sessions albeit shorter in duration (15 - 30mins).

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

At the start of the program, participants will be provided some educational materials (i.e an infographics, introductory video, etc.) e on topics such as personal health, the importance of exercise, habit building tips and information about the practice of QIgong. Educational materials are self-developed by the research team and be delivered via Physitrack, personal email, mobile text messaging. Participants can access program materials through their provided email, text messages, or through a participant handbook provided during the initial QGP program orientation session.

Procedures: Participants will be recruited within Australia. The QGP program will take place primarily online. The QGP live sessions and offline recordings will be led by a Qualified QIgong master instrutor experienced in the delivery of online and offline Qigong programs. Once a week, for 12 weeks, participants will attend an online group Qigong session led by the Qigong instructor. Participants will attend an online orientation session one week before QGP program commencement via Microsoft TEAMs, where they will meet with the Qigong instructor and a member of the research team. The orientation session will introduce participants to the program, and help them familirise the digital mediums used in the QGP program. Subsequently, each QGP online session will be 60-minutes, consisting of 45-minutes Qigong practice, followed by 15-minutes of meditation for self-awareness and reflection. Qigong exercises include but are not limited to 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 may also be adapted to better suit older adults (e.g minimising Qigong stances that require balancing on a single foot, etc.) In addition, participants are delivered guided Qigong recordings at the start of every week during the QGP program. The Qigong recordings follow a similar format to the live delivery sessions and will include similar exercises that participants have completed with the Qigong instructir, albeit vary in session duration, as participants may select their prefered duration of self-practice. Furthermore, educational materials are delivered to participants digitally (e.g email, text messaging, Physitrack messaging, etc.) at the start of every week for the purpose of building the participant's understanding for the importance of regular physical activity in promoting healthy ageing.
Intervention code [1] 327406 0
Lifestyle
Intervention code [2] 327407 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336602 0
Program adherence
Timepoint [1] 336602 0
Baseline, mid-program (6th week), end of program (Week 13, primary timepoint), 6 weeks post program
Primary outcome [2] 336603 0
Engagement Facilitators and Barriers
Timepoint [2] 336603 0
Baseline, mid-program (6th week), end of program (Week 13, primary timepoint), 6 weeks post program
Primary outcome [3] 336604 0
Safety
Timepoint [3] 336604 0
Baseline, mid-program (6th week), end of program (Week 13, primary timepoint), 6 weeks post program
Secondary outcome [1] 428935 0
Acceptability (This is an additional primary outcome)
Timepoint [1] 428935 0
Baseline, mid-program (6th week), end of program (Week 13, primary timepoint), 6 weeks post program
Secondary outcome [2] 428936 0
General Physical Activity frequency (This is an additional primary outcome)
Timepoint [2] 428936 0
Baseline, mid-program (6th week), end of program (Week 13, primary timepoint), 6 weeks post program
Secondary outcome [3] 435954 0
Body Awareness
Timepoint [3] 435954 0
Baseline, mid-program (6th week), end of program (Week 13), 6 weeks post program
Secondary outcome [4] 435955 0
Quality of Life
Timepoint [4] 435955 0
Baseline, mid-program (6th week), end of program (Week 13), 6 weeks post program

Eligibility
Key inclusion criteria
Older adults who fulfil the following criteria:
I. 60 years old and above
II. Living within the community
III. Have access to the internet.
IV. Have access to a device (mobile, tablet, laptop, etc.) to participate in program.
V. Must be able to perform basic limb movements in either sitting or standing positions.
VI. Must not have 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
The following individuals will be excluded from the study:
I. Older adults who are unable to independently access digitally delivered programs (e.g require external assistance to utilise telehealth).
II Individuals who are unable to independently engage in physical activity.
III. Individuals with severe balance, visual, hearing, and /or cognitive impairments.

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
Quantitative data: The non-parametric Wilcoxon signed-rank test will be used to compare differences between the pre- and post- intervention data for the (i) Physical Activity Scale for the Elderly, (ii) Body Awareness Questionnaire, and (iii) ED-5L-5Q. Statistical significance will be set to 0.05.

Qualitative data: Descriptive analysis of adverse events and technical issues that occurred during intervention delivery will be within the context of feasibility of implementation and used to supplement other feasibility factors identified through qualitative analysis. Qualitative data obtained from interviews and focus groups will be analysed using a reflexive inductive approach for thematic analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
Actual
17/04/2024
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
14
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315233 0
University
Name [1] 315233 0
RMIT University
Country [1] 315233 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
220 3-5 Plenty Road, Bundoora Victoria 3083
Country
Australia
Secondary sponsor category [1] 317272 0
None
Name [1] 317272 0
Address [1] 317272 0
Country [1] 317272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314157 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 314157 0
https://www.rmit.edu.au/research/our-research/ethics-and-integrity/human-ethics
Ethics committee country [1] 314157 0
Australia
Date submitted for ethics approval [1] 314157 0
20/11/2023
Approval date [1] 314157 0
06/02/2024
Ethics approval number [1] 314157 0
2024-26849-24141

Summary
Brief summary
Based on the findings of a previous research findings (RMIT Ethics Ref: 24895), we noted that a digitally delivered Qigong program for older adults, the Qigong Plus Program, was both feasible and acceptable amongst pilot study participants. Therefore, this follow-up project will build upon previous findings and deliver an enhanced Qigong program for older adults that employs additional behaviour change interventions strategies to sustain participant engagement, both during the program and subsequently promoting long-term Qigong practice. The use of pre-recorded sessions allows the participant freedom to decide the timing for their program delivery, resulting in a heightened sense of perceived self-agency towards their health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130618 0
A/Prof A/Prof Zhen Zheng
Address 130618 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 130618 0
Australia
Phone 130618 0
+61 3 9925 7167
Fax 130618 0
Email 130618 0
zhen.zheng@rmit.edu.au
Contact person for public queries
Name 130619 0
A/Prof A/Prof Zhen Zheng
Address 130619 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 130619 0
Australia
Phone 130619 0
+61 3 9925 7167
Fax 130619 0
Email 130619 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 130620 0
A/Prof A/Prof Zhen Zheng
Address 130620 0
RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
Country 130620 0
Australia
Phone 130620 0
+61 3 9925 7167
Fax 130620 0
Email 130620 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.