Feasibility of an aquatic exercise therapy intervention for falls prevention in older adults
| ISRCTN | ISRCTN15865400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15865400 |
| Secondary identifying numbers | HIPS/23/04 |
- Submission date
- 04/06/2025
- Registration date
- 04/06/2025
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
One-third of people aged 65 years or over fall every year. Falls reduce quality of life, lead to nursing home admissions, cause about 90% of hip fractures and half of deaths due to injury. Several factors that increase fall risk can be improved, such as balance, muscle weakness, mobility and physical function. Exercise on land has a positive effect on these factors, can reduce falls by up to a third. Aquatic exercise has some advantages compared to exercise on land. For example, buoyancy reduces spine and joint loads, and the pressure of the water on the body assists with balance and mobility. The aim of this study was to design and deliver an aquatic exercise intervention for people at high risk of falls. We assess whether people are willing/able to participate and complete the intervention, have a preliminary look at the programme’s effects on falls risk and compare it with an established land exercise programme for falls prevention.
Who can participate?
People over 50 years old, with a history of falling (or increased risk of falling), poor gait or balance, or feeling unsteady. They must be living independently and be physically able to take part in an exercise class.
What does the study involve?
For the aquatic exercise group, a 16-week programme with two 30-minute supervised sessions in shallow water (waist-to-chest depth) per week, educational advice on falls prevention and optional recommended exercises to do at home. Three testing sessions, at the start, end, and 6 months after the end of the intervention. Optional weekly/monthly diaries on falls, adverse events and home/other exercise. The land exercise group do the same as above, but a single 60-minute exercise session weekly instead of two 30-minute sessions.
What are the possible benefits and risks of participating?
It is possible that the programme will improve balance, strength, mobility and physical function. This may reduce the risk of having a fall, and could have a positive impact on health and quality of life.
During or after exercising, there is a risk that one may feel some muscle discomfort, soreness or stiffness. This is more likely in the first few weeks, especially if one is unused to exercise. We ask and encourage participants to report this to us, and we provide suitable advice whenever required. For the aquatic sessions, the poolside floors are sometimes slippery and may present a fall hazard, so we are taking a series of measures to minimise any risk
Where is the study run from?
The study is led by researchers at the University of Edinburgh, in collaboration with Glasgow Caledonian University and Edinburgh Leisure (UK)
When is the study starting and how long is it expected to run for?
October 2022 to September 2025
Who is funding the study?
The study is being funded by the Chief Scientist Office, which is one of the Scottish Government’s Health Directorates.
Who is the main contact?
Dr Stelios Psycharakis, stelios.psycharakis@ed.ac.uk
Contact information
Public, Scientific, Principal Investigator
Institute for Sport, Physical Education and Health Sciences
The University of Edinburgh
St Leonard’s Land, Holyrood Road
Edinburgh
EH8 8AQ
United Kingdom
 ORCID ID |
0000-0003-2138-0930 |
|---|---|
| Phone | +44 (0)131 651 6587 |
| stelios.psycharakis@ed.ac.uk |
Study information
| Study design | Multi-center interventional non-randomized controlled feasibility trial with two arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Fitness/sport facility |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility of an AQUAtic exerciSe ThEraPy intervention for falls prevention in older adultS at high risk of falls (AQUA STEPS)- exploration of its effects on falls and risk factors for falls, and comparison with an established land exercise falls prevention programme |
| Study acronym | AQUA STEPS |
| Study objectives | There are two research questions: 1. Do the key aspects of the aquatic intervention delivery justify a full-scale trial? Such aspects include participant uptake and retention, centre recruitment, procedures implementation and adverse events. 2. Do the outcome measures of falls risk show responsiveness to change for the aquatic intervention? If so, is this responsiveness similar for the aquatic and land interventions? |
| Ethics approval(s) |
Approved 27/09/2023, Moray House School of Education and Sport Ethics Sub-Committee, The University of Edinburgh (Old Moray House, Holyrood Road, Edinburgh, EH8 8AQ, United Kingdom; +44 (0)131 651 4846; MHSES-Ethics@ed.ac.uk), ref: SPSY31082023 |
| Health condition(s) or problem(s) studied | Prevention of falls in older adults who have a high risk of falls |
| Intervention | The study was not randomised. Participants self-referred to the aquatic arm before being checked for eligibility. For the land arm, participants who had been referred by a health professional to the Steady Steps falls programme and had their eligibility confirmed by the Steady Steps team were invited to participate in the land arm of the study. A 16-week exercise intervention taking place in shallow water in indoor swimming pools. Two 30-min supervised exercise sessions in the pool per week, plus education on falls prevention, and optional recommended home exercises. Testing at baseline, end of intervention, and after a six-month follow-up period. People self-refer to this intervention arm, are assessed for eligibility and, if confirmed, are allocated to the aquatic group (i.e., not randomised). The comparator is an established land exercise programme ('Steady Steps') that has been running independently for 12 years and service evaluations have indicated positive outcomes. People are referred to this programme by a health professional and eligibility is double-checked and confirmed by the programme team. During the recruitment period, people who are referred to the programme are also invited to join the study by being part of the land exercise group. The land exercise group do the same as above, but a single 60-min exercise session weekly instead of two 30-min sessions. There is a comprehensive set of assessments at the three timepoints. |
| Intervention type | Other |
| Primary outcome measure | Feasibility of Aqua Steps, including: 1. Recruitment: ≥70% of participants for the Aqua Steps group recruited within 6 months (measured as people recruited expressed as a percentage of the target of 50) 2. Retention: ≥50% of participants in the Aqua Steps group to remain on the programme until the end of the intervention (measured as the number of participants in the aquatic arm who complete the intervention, expressed as a percentage of the number of participants who started the intervention) 3. Adverse events: <10% of any severe adverse effects deemed to be due to the aquatic intervention (severe adverse effects tracked through weekly diaries and instructor reporting, recorded on adverse event forms, and categorised as mild, moderate and severe) 4. Some evidence of improvement on key risk factors for falls: Evidence of improvement in some of the tests and questionnaires presented as the secondary outcome measures |
| Secondary outcome measures | 1. Falls and fallers assessed using questionnaire (number of falls, number of fallers/non-fallers/frequent fallers, and fall rate per person year) at baseline and 6-month follow-up Measured at baseline, end of intervention and 6-month follow-up: 2. 3 m Timed up and go (functional test, time in seconds) 3. Chair rises in 30 seconds (functional test, number of rises) 4. Functional reach (functional test, distance in cm) 5. Peak isometric knee extension force (strength test, N/kg) 6. Peak isometric knee flexion force (strength test, N/kg) 7. Peak isometric grip force (strength test, N/kg) 8. Postural stability with double and single leg stance (balance test, distance and speed of centre of pressure, in cm and cm/s) 9. Falls efficacy/fear of falling questionnaire (FES-I, range is 16-64 points, greater score = more concerned) 10. Balance confidence questionnaire (Confbal, range is 10-30 points, greater score = lower confidence) 11. Quality of life questionnaire (OPQOL-13, general question: 1-5 points, total score: 13-65 points; greater score = better quality of life) 12. Health status questionnaire (EQ-5D-5L, 0-100 points for visual analogue scale (VAS, greater score = better health), -0.594 to 1.000 for index value (applicable to UK population, greater score =better health) 13. Acceptability questionnaire (adapted version of the theory-driven generic questionnaire of acceptability of healthcare interventions from the participants’ perspective; range is 1-5 points, greater score = greater acceptability) |
| Overall study start date | 16/10/2022 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Population, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 101 |
| Key inclusion criteria | 1. People ≥50 years 2. Living independently (e.g. not in care homes) 3. Physically able to take part in an exercise class 4. Being able to self-monitor and regulate the intensity of exercise 5. Having an increased risk of falling or a history of falling, poor gait/balance or feeling unsteady |
| Key exclusion criteria | 1. Recent injurious fall without a medical examination 2. Significant cognitive impairment 3. Already participating in an individually prescribed exercise programme 4. Having contra-indications for exercise on land or in the water (e.g. respiratory conditions requiring O2 or compromised lung volumes; skin infections; allergy to chlorine; fear of water; incontinence; severe visual or vestibular disturbances; dementia; vascular conditions affecting sensation; any of the following if uncontrolled: heart disease, blood pressure, hypertension, pain, tachycardia, other uncontrolled mental health conditions) |
| Date of first enrolment | 31/01/2024 |
| Date of final enrolment | 17/07/2024 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
EDINBURGH
EH11 2AL
United Kingdom
Edinburgh
EH9 1AP
United Kingdom
Edinburgh
EH5 2HF
United Kingdom
Edinburgh
EH3 5JB
United Kingdom
Penicuik
EH26 9EP
United Kingdom
EDINBURGH
EH10 4DD
United Kingdom
EDINBURGH
EH16 5BB
United Kingdom
EDINBURGH
EH14 1XN
United Kingdom
EH4 6NS
United Kingdom
Edinburgh
EH4 7SF
United Kingdom
Edinburgh
EH16 6RN
United Kingdom
Edinburgh
EH6 5JA
United Kingdom
Edinburgh
EH15 2BS
United Kingdom
Edinburgh
EH7 6AE
United Kingdom
Sponsor information
University/education
College of Arts, Humanities and Social Sciences Research Governance Office
55 George Square
Edinburgh
EH8 9JU
Scotland
United Kingdom
| Phone | +44 (0)131 650 3487 |
|---|---|
| Matt.Erikson@ed.ac.uk | |
| Website | https://www.ed.ac.uk/ |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals Planned dissemination in open public seminars, academic and professional conferences and events, etc |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
06/06/2025: The public title was changed from 'Aquatic exercise therapy for falls prevention in older adults ' to 'Feasibility of an aquatic exercise therapy intervention for falls prevention in older adults'.
04/06/2025: Study's existence confirmed by the Moray House School of Education and Sport Ethics Sub-Committee.
