Can yoga reduce the risk of falls and improve mindful eating and quality of life in adults aged 60 years and over?
| ISRCTN | ISRCTN51787455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51787455 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 253-2019 |
| Sponsor | Sunnybrook Academic Family Health Team |
| Funder | Sunnybrook Academic Family Health Team |
- Submission date
- 02/12/2019
- Registration date
- 19/12/2019
- Last edited
- 12/02/2021
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
The objective of this study is to preliminarily assess the impact of an interprofessional therapeutic yoga program for older adults on falls risk, mindful eating and quality of life DESIGN--Mixed methods pilot study with pre-post design. Participants in an interprofessional therapeutic yoga program will be assessed for falls risk, mindful eating and self-reported quality of life before and after the program. The yoga program offers gentle yoga as well as education sessions and practices by an occupational therapist, a dietitian and a family physician. SETTING--Assessments will be conducted at the Sunnybrook Academic Family Health Team. Classes are held in a community activity space. PATIENTS-- A total of 12 participants will be recruited. OUTCOME MEASURES--Fullerton Advanced Balance Scale, sit-to-stand test, Falls Efficacy Scale, Mindful Eating Behaviour Scale, 36-Item Short Form Health Survey, focus group.
Background and study aims
Older adults may have difficulty maintaining a healthy lifestyle due to challenges related to mobility and balance, cognition (thinking and memory), eating habits, sleep quality, mood and social isolation. Yoga for older adults has shown to have positive effects on health and quality of life and to support healthy eating behaviours. This study aims to investigate whether a program for older adults including yoga, guidance on healthy eating, mindfulness and general health and wellbeing can reduce the likelihood of a person having a fall, increase their quality of life and improve mindful eating.
Who can participate?
People enrolled in a team-based therapeutic yoga program who are 60 years of age or older. The program is offered in the community and there is no cost to attend.
What does the study involve?
Participants will be assessed for self-reported quality of life, mindful eating and falls risk before and after the program. They will then receive an 8-week course of twice-weekly yoga sessions as well as educational sessions on healthy eating and general health and wellbeing. They will be assessed again after the end of the program and will also be invited to attend a focus group 4-8 weeks after the end of the program to find out what they thought of the program and what changes they had made to their lifestyle.
What are the possible benefits and risks of participating?
Participants may benefit from learning more about their health through the results of their pre- and post-assessments. They might also benefit if there are improvements to their risk of falling, diet and quality of life as a results of this program.
Anxiety, distress, embarrassment, and/or feelings of sadness may arise from answering questionnaires and interviews about sensitive issues. The Fullerton Advanced Balance scale asks participants to perform various movements that assess static and dynamic balance. As such, there is a small risk of falls and injury. A regulated physiotherapist will be administering this assessment and will administer it in the safest way possible. Participants will be instructed to refrain from any movement they do not feel comfortable with.
Where is the study run from?
Sunnybrook Academic Family Health Team (Canada)
When is the study starting and how long is it expected to run for?
July 2019 to October 2022 (updated 12/02/2021, previously: October 2021, updated 18/03/2020, previously: October 2020)
Who is funding the study?
Sunnybrook Academic Family Health Team (Canada)
Who is the main contact?
Ingrid Wirsig, ingrid.wirsig@sunnybrook.ca
Contact information
Public
2075 Bayview Avenue, A145b
Toronto
M4N 3M5
Canada
| Phone | +1 416-480-6942 |
|---|---|
| ingrid.wirsig@sunnybrook.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized single-arm interventional single-center pilot study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The impact of an interprofessional therapeutic yoga program for older adults on falls risk, mindful eating and quality of life: A pilot study |
| Study objectives | A twice-weekly, 8-week interprofessional therapeutic yoga program for older adults will have a positive impact on falls prevention, nutrition, and quality of life. |
| Ethics approval(s) | Approved 04/12/2019, Sunnybrook Health Sciences Centre Research Ethics Board (Room C819, 2075 Bayview Ave, Totonto, ON, Canada M4N 3M5; +1 416 480 6100 ext 4276; no email address), ref: 253-2019 |
| Health condition(s) or problem(s) studied | Healthy aging |
| Intervention | This is a pilot study with pre-post design using mixed methods. Participants will be recruited from among interprofessional therapeutic yoga program participants. The principal investigator (PI) will be the first point of contact. She will confirm interest and ensure study participants meet the inclusion/exclusion criteria. The research assistant (RA) will contact eligible participants, explain the consent process and book an assessment appointment at the Sunnybrook Academic Family Health Team. Participants will be asked to attend two 60-min assessment appointments within the 2-week timeframe before the program begins and the 2-week timeframe after the program ends. During the assessment appointment, participants will be asked to fill out the following assessment questionnaires: Falls Efficacy Scale (FES), Mindful Eating Behaviour Scale (MEBS) and 36-Item Short Form Health Survey (SF-36). In addition, a registered physiotherapist will assess each participant for balance and strength using the Five times Sit to Stand Test (FTSTS) and the Fullerton Advanced Balance (FAB) Scale. Participants will attend an 8-week interprofessional therapeutic yoga program in the spring of 2020. Classes are held two times a week and are 90 min each. A yoga therapist will lead mindful meditation, gentle movement, breath awareness and relaxation exercises in the yogic tradition. An occupational therapist will lead four 30-min education sessions around falls prevention, home safety, community resources and advanced care planning. A dietitian will lead two 30-min sessions around mindful eating. A family physician will lead one 30-min education session around the benefits of mindfulness and yoga for hypertension prevention and management as well as for overall health and wellness. Participants will be invited to attend a focus group in the summer of 2020 to share their experiences in the program, what they learned, what they liked best, whether they have changed their habits and how, feasibility of program, opportunities for improving the program. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Static and dynamic balance assessed using the Fullerton Advanced Balance Scale at pre- and post-intervention |
| Key secondary outcome measure(s) |
1. Additional benefits of intervention assessed using qualitative feedback from a participant focus group after the end of the intervention |
| Completion date | 15/10/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 12 |
| Key inclusion criteria | 1. Participants in the Sunnybrook Academic Family Health Team interprofessional therapeutic yoga program 2. Aged 60 years or older |
| Key exclusion criteria | 1. Has participated in a previous yoga program at the Sunnybrook Academic Family Health Team 2. Has participated in a falls prevention program in the past 12 months |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 15/03/2022 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M4N 3M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/02/2021: The following changes have been made:
1. The recruitment start date was changed from 01/02/2021 to 01/02/2022.
2. The recruitment end date was changed from 15/03/2021 to 15/03/2022.
3. The overall end date was changed from 15/10/2021 to 15/10/2022.
4. The intention to publish date was changed from 01/11/2021 to 01/11/2022.
5. The plain English summary was updated to reflect these changes.
11/06/2020: Due to current public health guidance, recruitment for this study will be paused until further notice.
18/03/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/02/2020 to 01/02/2021.
2. The recruitment end date was changed from 15/03/2020 to 15/03/2021.
3. The overall end date was changed from 15/10/2020 to 15/10/2021.
4. The intention to publish date was changed from 01/11/2020 to 01/11/2021.
5. The plain English summary was updated to reflect these changes.
13/12/2019: Trial's existence confirmed by Sunnybrook Health Sciences Centre Research Ethics Board.
