Mobility and balance in recurrently falling nursing home residents using a side-stepping exercise
| ISRCTN | ISRCTN13584053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13584053 |
- Submission date
- 30/08/2022
- Registration date
- 01/09/2022
- Last edited
- 05/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Side-stepping is a potential exercise program to reduce fall risk by improving mobility and balance in community-dwelling adults in their seventies, but it has never been tested in nursing home older residents. This was a pilot quasi-experimental study to examine the feasibility and potential benefits of an intervention based solely on voluntary non-targeted side-stepping exercises on mobility and balance in nursing home residents who fall recurrently.
Who can participate?
Nursing home residents of "Le Richemont", over 60 years old, recurrent fallers, and able to stand and walk alone or with technical/ verbal assistance for a distance of 10 meters.
What does the study involve?
A group of participants that follow a side-stepping exercise program is compared to a group following usual physiotherapy care.
What are the possible benefits and risks of participating?
The possible benefits are mobility and balance improvements. A risk is falling during the intervention.
Where is the study run from?
Le Richemont, a nursing home in Belgium.
When is the study starting and how long is it expected to run for?
June 2017 to March 2021.
Who is funding the study?
Rehazenter (Luxembourg)
Who is the main contact?
Frédéric Dierick, PhD
frederic.dierick@gmail.com
Contact information
Principal Investigator
Rue André Vésale 1
Luxembourg
2674
Luxembourg
 ORCID ID |
0000-0003-2061-0968 |
|---|---|
| Phone | +352 26 98 43 10 |
| frederic.dierick@rehazenter.lu |
Study information
| Study design | Single-center interventional quasi-experimental |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Mobility and balance in recurrently falling nursing home residents by voluntary non-targeted side-stepping exercise intervention |
| Study acronym | SIDE |
| Study objectives | Training based solely on voluntary non-targeted side-stepping exercises might be feasible and effective in improving the mobility and balance of nursing home residents who fall recurrently. |
| Ethics approval(s) | Approved 28/08/2017, Academic Bioethics Committee (Comité académique de bioéthique, 91, avenue Ch. Schaller, 1160 Bruxelles, Belgium; no telephone number provided; secretary@a-e-c.eu), ref: B200-2017-090 |
| Health condition(s) or problem(s) studied | Prevention of falls in nursing home residents |
| Intervention | This is a pilot quasi-experimental study to examine the feasibility and potential benefits of an intervention based solely on voluntary non-targeted side-stepping exercises on mobility and balance in nursing home residents who fall recurrently. Participants are recruited and assigned to an intervention group (side-stepping exercises, STEP) participating in an 8-week protocol and to a control group (usual physiotherapy care, CTRL). They were clinically assessed at 4-time points: baseline, after 4 and 8 weeks, and after a 4-week follow-up period (usual physiotherapy care). The intervention consisted of replacing the usual physiotherapy care sessions (total duration of about 120 minutes per week: 20–25 minutes per day) with an intervention consisting solely of voluntary sidestepping exercises. In the nursing home, the usual physiotherapy sessions mainly included walking on level ground, ascending and descending stairs, and upper and lower limb strengthening exercises. During the side-stepping exercises intervention period (t1–t3), participants were trained 4 days per week for 30 minutes each. Daily training time could be divided into two periods of 15 minutes if the participant had difficulty participating in a single 30-minute session because of fatigue or other reasons. Voluntary side-stepping movements were performed in left and right directions, in front of a horizontal bar located 90cm from the floor and situated in a corridor. For the right-hand sidestepping movements, the right foot was moved approximately 15–20cm to the right, then the left foot to join the right, and so on. For the left-hand sidestepping movements, the reverse order was chosen. Participants were instructed to perform the sideways steps while keeping their heads in a neutral position, looking straight ahead, and watching the position of their feet as little as possible. For safety reasons, participants were asked never to cross their feet. |
| Intervention type | Behavioural |
| Primary outcome measure | Mobility and balance are measured with Timed Up and Go (TUG) and Berg Balance Scale (BBS) at baseline, after 4 and 8 weeks, and after a 4-week follow-up period. |
| Secondary outcome measures | Mobility and balance are measured at baseline, after 4 and 8 weeks, and after a 4-week follow-up period: 1. 6-minute walking test (6MWT) 2. Tinetti Performance Oriented Mobility Assessment (Tinetti) 3. Mini motor test (MMT) 4. 6-meter walking test (6mWT) |
| Overall study start date | 10/06/2017 |
| Completion date | 15/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 22 participants (11 in STEP and 11 in CTRL) |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Over 60 years old 2. A recurrent faller 3. Able to stand and walk alone or with technical/ verbal assistance for a distance of 10 meters 4. Able to understand the instructions given for intervention and assessment |
| Key exclusion criteria | 1. Severe vascular disease 2. Epileptic seizures |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 15/12/2020 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Bioul-Anhée
5537
Belgium
Sponsor information
Hospital/treatment centre
Rue André Vésale 1
Luxembourg
2674
Luxembourg
| Phone | +352 26 98 43 10 |
|---|---|
| direction@rehazenter.lu | |
| Website | https://rehazenter.lu/fr/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets analyzed during the current study are available on request from frederic.dierick@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/12/2022 | 05/01/2023 | Yes | No |
Editorial Notes
05/01/2023: Publication reference added.
31/08/2022: Trial's existence confirmed by Academic Bioethics Committee
