AquaReBal - Aquatic Reactive Balance Training for Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJózef Piłsudski University of Physical Education
About this trial
Falls are the second leading cause of accidental injury deaths worldwide, mostly in older adults. Injuries resulting from a fall are a leading cause of hospitalizations among older adults in Canada with a higher total injury cost than any other cause of injury. People must often perform rapid and complex movements to keep from falling. Reactive balance training (RBT) is a type of training that focuses on improving an individual's ability to perform those types of movements and respond to unexpected or sudden changes. RBT and aquatic therapy were identified as a research priority for fall prevention. There is evidence that RBT reduces the rate of falls by a half in daily life and improvements in reactive balance are maintained up to a year after the end of the program. When RBT is conducted on land, some adverse events such as fear of falling and joint pain may occur. The water environment could minimize the limitations and barriers associated with land-based RBT. To date, there are no studies showing the effects of water-based RBT on reactive balance control in older adults.The study aims to explore if water-based RBT is a practical intervention to reduce the number of falls in older adults. Older adults will be recruited from the Greater Toronto Area. They will receive training 2 times per week for 6 weeks. The main practical factors around the intervention, such as how participants adhere to the treatment and how they accept the intervention will be measured. It will be assessed how the water-based and land-based RBT affects falls, balance, mobility and quality of life. With this study, the aim is to inform the way for a larger study targeting falls - one of the biggest problems among older adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
65 years and older
able to stand ≥1 min
able to independently walk ≥10 m without assistance
a history of ≥2 falls in the past 12 months, history of an injurious fall in the past 12 months, and/or self-reported balance difficulties
Disqualifiers
Current diagnosis of neurological or sensory disorders
uncorrected vision problems
recurrent dizziness
cognitive deficits
Trial design
Design model
Single group
Treatments tested in this trial
AquaReBal
Other interventionThe interventions will be delivered one-on-one, in person at the KITE Research Institute by a trained and licensed physiotherapist. We will follow an RBT program previously developed by co-investigators. The interventions will be matched as closely as possible for frequency, intensity and time. The exercise interventions will be based on internal and external perturbations. Therapist-applied perturbations and multiple perturbation types and directions are of most benefit in terms of reactive balance control, so our study will focus on manual perturbations; the perturbations will be strong enough to cause stepping reactions. Interventions will be tailored to the individual participants' abilities. Each session will include a 10 min warm-up, at least 40 min of perturbations and a 10 min cool-down. Internal perturbations will be achieved by asking the participant to complete tasks that challenge balance control, such that they lose balance when attempting to perform the task.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: AquaReBal - water-based RBTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility
Feasibility of recruitment, adherence and intervention fidelity will be measured. Because feasibility is a multidimensional construct we will also collect qualitative data about recruitment capability, randomization acceptability, data collection procedures and outcome measures, intervention delivery, intervention adherence and safety, barriers and facilitators to implementing the study, and retention of participants. Qualitative methods will include one-on-one interviews, unstructured observations, field notes and session recordings. We will use a flexible approach with regard to timing when qualitative data is collected as problems and implementation barriers arise; this will allow us to document information in real time, thus allowing us to make necessary refinements to the intervention and study protocol.
Time frame
From enrollment to the end of treatment at 6 weeks and at 6 months post interventionSecondary outcomes
1
Falls monitoring
The number of falls experienced by the participants will be monitored. Within 24 hours of experiencing a fall, the participants will complete a fall survey, either online or on paper. The survey will be composed of multiple-choice questions with closed-ended answers concerning the location of the fall and time of the day, as well as multiple-choice questions with an open-ended "other" option regarding the activity being performed at the time of the fall and potential contributing variables. In addition the survey will include questions about possible injuries from falling. A researcher will conduct monthly interviews with participants by phone or MS Teams to ensure the fall surveys are completed.
Time frame
From enrollment to the end of treatment at 6 weeks and 6 months post intervention2
The Mini Balance Evaluation Systems Test (mini-BESTest)
The Mini Balance Evaluation Systems Test (mini-BESTest) is a 14-item observational rating scale that assesses systems underlying balance control, including reactive balance control and dynamic stability during walking. The Mini-BESTest is reliable and valid, and able to identify fall status in older people living in the community.
Time frame
From enrollment to the end of treatment at 6 weeks and 6 months post intervention3
Timed Up and Go (TUG)
Timed Up and Go (TUG) is a commonly-used screening tool for fall risk in the inpatient and community setting. A faster time indicates better functional performance and a score of ≥13.5 s is used as a cut-point to identify those at increased risk of falls. The TUG test has shown acceptable psychometric properties and is considered appropriate for the general older adult population.
Time frame
From enrollment to the end of treatment at 6 weeks and at 6 months post intervention4
Physical activity
The Physical Activity Scale for the Elderly (PASE) is a 12-item reliable and valid self-report instrument specifically designed for older adults. It is used to assess physical activity over a one-week time period.
Time frame
From enrollment to the end of treatment at 6 weeks and at 6 months post interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Józef Piłsudski University of Physical Education
Lead sponsor
Toronto Rehabilitation Institute
Collaborator
Source ClinicalTrials.gov
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