Adaptation and implementation of health Qigong and Tai Chi exercises on quality of life and physical functioning in patients with atrial fibrillation: a feasibility study
| ISRCTN | ISRCTN16703816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16703816 |
| IRAS number | 286914 |
| Secondary identifying numbers | IRAS 286914, CPMS 49781 |
- Submission date
- 28/02/2022
- Registration date
- 25/03/2022
- Last edited
- 13/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Tai Chi and Qigong traditional Chinese exercises are thought to be beneficial in many health conditions including heart conditions, however, there is a lack of studies showing the effect of these exercises on patients with atrial fibrillation (AF; the most common irregular heart rhythm). Therefore, the aim of this research is: To assess the feasibility of a future randomised controlled trial of Tai Chi and Qigong for patients with atrial fibrillation in terms of patients’ acceptability and capability to continue the programme and their satisfaction with it, in addition to evaluating health-related quality of life and physical functioning.
Who can participate?
Approximately 106 adult participants with confirmed AF diagnoses will be recruited from primary care.
What does the study involve?
The study will take place online via the virtual platform (Zoom).
The exercise group will learn a Tai Chi and Qigong routine for 12 weeks, led by a qualified instructor. All the movements will be carried out according to the participants' capability. The participants in both groups may be interviewed online for process evaluation requirements; and 10 participants from the intervention group for the embedded qualitative study.
What are the possible benefits and risks of participating?
Benefits
This study provides an opportunity for participants to learn new exercise movements which may help to improve health and well-being. The exercises will be delivered in a group format (either in person or via video-link), and participants may find some benefit from meeting up with other people.
Risks
This study will provide specially designed exercise movements suitable for older adults, which are of low to moderate intensity. Unexpected serious adverse events may occur but most likely will not be research-related events. Participants may experience some muscle/joint ache after taking part, but this risk is low.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
March 2020 to December 2023
Who is funding the study?
The study is funded by the Libyan Embassy - Cultural Attache.
Who is the main contact?
Ms Ahlam Abu Elkhair, ahlam244@liverpool.ac.uk
Contact information
Principal Investigator
William Henry Duncan Building
University of Liverpool
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
 ORCID ID |
0000-0002-0086-6600 |
|---|---|
| Phone | +44 7424101981 |
| ahlam244@liverpool.ac.uk |
Scientific
William Henry Duncan Building
University of Liverpool
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
| Phone | +44 7424101981 |
|---|---|
| ahlam244@liverpool.ac.uk |
Public
William Henry Duncan Building
University of Liverpool
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
| Phone | +44 7424101981 |
|---|---|
| ahlam244@liverpool.ac.uk |
Study information
| Study design | Interventional randomized controlled trial feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Adaptation and implementation of health Qigong and Tai Chi exercises on quality of life and physical functioning in patients with atrial fibrillation: a feasibility study |
| Study objectives | To assess the feasibility of a future randomised controlled trial of Tai Chi and Qigong for patients with atrial fibrillation in terms of patients’ acceptability and capability to continue the programme and satisfaction with it, in addition to evaluating health-related quality of life and physical functioning. |
| Ethics approval(s) | Approved 04/08/2021, North West - Liverpool Central Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048016; liverpoolcentral.rec@hra.nhs.uk), ref: 21/NW/0183 |
| Health condition(s) or problem(s) studied | Tai Chi and Qigong for patients with atrial fibrillation. |
| Intervention | Current intervention as of 27/12/2023: Approximately 106 participants will be recruited from primary care. The study took place online via the virtual platform (Zoom). The participants were randomly assigned to either the control (usual care) or intervention group (Tai Chi/Qigong). The exercise group learned a Tai Chi and Qigong routine, led by a qualified instructor. All the movements were carried out according to the participants' capabilities. The participants in both groups may be interviewed online for process evaluation requirements; and 10 participants from the intervention group for the embedded qualitative study. Participants in the control group will receive usual care for the management of atrial fibrillation, consisting of stroke prevention (oral anticoagulation), AF-symptom management (rate and/or rhythm control), and management of cardiovascular and other comorbidities, as appropriate. Participants in the intervention group will practise Qigong and Tai Chi exercises for 60 minutes for up to three sessions per week (one session minimum) for 12 weeks, either in the local community centre or online via Zoom in groups. Patients will also receive usual care for the management of atrial fibrillation. _____ Previous intervention: Approximately 106 participants will be recruited from primary care. The study will take place in the community centres and/or online via the virtual platform (Zoom). The participants will be randomly assigned to either control (usual care) or intervention group (Tai Chi/Qigong). The exercise group, will learn a Tai Chi and Qigong routine, led by a qualified instructor. All the movements will be carried out according to the participants' capability. The participants in both groups may be interviewed online for process evaluation requirements; and 10 participants from the intervention group for the embedded qualitative study. Participants in the control group will receive usual care for the management of atrial fibrillation, consisting of stroke prevention (oral anticoagulation), AF-symptom management (rate and/or rhythm control), and management of cardiovascular and other comorbidities, as appropriate. Participants in the intervention group will practise Qigong and Tai Chi exercises for 60 minutes for up to three sessions per week (one session minimum) for 12 weeks, either in the local community centre or online via Zoom in groups. Patients will also receive usual care for the management of atrial fibrillation. |
| Intervention type | Other |
| Primary outcome measure | Recruitment rate and retention rate at baseline, during 12 weeks of the intervention: 1. Recruitment rate: the number of the returned consent-to-contact forms will be calculated from the total number of invitations sent to eligible patients (response rate). The total number of those who will attend the intervention will be counted and will be divided by the number of invitations sent. 2. Retention rate: the number of sessions that participants attend over the 12 weeks will be collected and whether they complete the whole session each time or not. 100% attendance will be recorded as a minimum of one session per week for 12 weeks. |
| Secondary outcome measures | Current secondary outcome measures as of 27/12/2023: 1. Health-related quality of life and physical functioning assessed using the Short Form 12-item questionnaire (SF-12), Atrial Fibrillation Effect on Quality-of-life (AFEQT) Questionnaire, and the EuroQol questionnaire (EQ-5D) at baseline, 6 and 12 weeks 2. Patient satisfaction with the intervention was measured using a researcher-developed questionnaire at 12 weeks _____ Previous secondary outcome measures: 1. Health-related quality of life will be assessed using the Short Form 12-item questionnaire (SF-12), Atrial Fibrillation Effect on Quality-of-life (AFEQT) Questionnaire, and the EuroQol questionnaire (EQ-5D), at baseline, 6 and 12 weeks 2. Physical functioning will be measured by the 6-minute walk test (6MWT), at baseline, 6 and 12 weeks 3. Balance, gait and mobility will be measured by The Short Physical Performance Battery test (SPPB), at baseline, 6 and 12 weeks 4. Patient satisfaction with the intervention will be measured using a researcher-developed questionnaire, at 12 weeks |
| Overall study start date | 01/03/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 106 |
| Total final enrolment | 74 |
| Key inclusion criteria | 1. Confirmed diagnosis of AF. 2. Able to understand spoken English. 3. Able to provide written informed consent. 4. Adults aged ≥18 years old. 5. If social distancing due to COVID-19 persists: the participants should have internet access at home and download free Zoom software onto a computer, mobile phone, or any electronic tablet or TV for delivery of the exercise intervention. |
| Key exclusion criteria | 1. Pre-existing medical condition preventing safe exercising (i.e., inability to stand unaided). |
| Date of first enrolment | 18/01/2022 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
Liverpool
L7 5ND
United Kingdom
Sponsor information
University/education
4th Floor Thompson Yates Building
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 151 794 8373 |
|---|---|
| sponsor@liv.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | The obtained results from this study will be published in scientific journals and reported at scientific conferences and meetings. In addition, all participants will be informed of the study results once published. |
| IPD sharing plan | The data will be held at the University of Liverpool. Requests for de-identified data can be made, along with details on the planned analyses. Data will not be available until 2025. All data will be de-identified. All participants will provide written informed consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 13/12/2024 | No | No |
Additional files
Editorial Notes
13/12/2024: Unpublished results uploaded.
27/12/2023: The following changes have been made:
1. The intervention has been changed.
2. The secondary outcome measures have been changed.
3. East Wavertree and Childwall Community Centre has been removed from the study participating centres.
4. The plain English summary has been updated to reflect these changes.
09/05/2023: The total final enrolment was added.
31/03/2023: The recruitment end date has been changed from 31/01/2023 to 30/04/2023.
28/11/2022: The recruitment end date was changed from 30/11/2022 to 31/01/2023.
03/05/2022: The study contact has been updated and the plain English summary has been updated accordingly.
01/04/2022: added CPMS number to Protocol /serial number field.
25/03/2022: The public title has been changed from "Health Qigong/Tai Chi and irregular heart rhythm" to "Adaptation and implementation of health Qigong and Tai Chi exercises on quality of life and physical functioning in patients with atrial fibrillation: a feasibility study".
01/03/2022: Trial's existence confirmed by North West - Liverpool Central Research Ethics Committee
