AquaReBal - Aquatic Reactive Balance Training for Older Adults

NCT06720974 | Not Yet Recruiting

• 1 other identifier: 25-5483
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Older Adults, Balance; Older People; Aquatic Physical Exercise

Outcome Measures

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.

  From enrollment to the end of treatment at 6 weeks and at 6 months post intervention

Secondary Outcomes (7)

• Falls monitoring

  From enrollment to the end of treatment at 6 weeks and 6 months post intervention

• The Mini Balance Evaluation Systems Test (mini-BESTest)

  From enrollment to the end of treatment at 6 weeks and 6 months post intervention

• Timed Up and Go (TUG)

  From enrollment to the end of treatment at 6 weeks and at 6 months post intervention

• Physical activity

  From enrollment to the end of treatment at 6 weeks and at 6 months post intervention

• Psychological consequences

  From enrollment to the end of treatment at 6 weeks and 6 months post intervention

Study Arms (1)

AquaReBal - water-based RBT

EXPERIMENTAL

AquaReBal (water-based RBT) will be conducted at a warm therapy pool. Participants will not wear a safety harness in water as there is minimal risk of injury due to the water properties. The level of the water will be between umbilicus and xiphoid process to allow the participant to freely move in the standing position and ensure safety during perturbations. In addition, in the tasks that involve moving, the turbulence of the water will create additional perturbations.

Other: AquaReBal

Interventions

AquaReBal OTHER

The 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.

AquaReBal - water-based RBT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current diagnosis of neurological or sensory disorders
• uncorrected vision problems
• recurrent dizziness
• cognitive deficits
• medical conditions that could increase injury risk during balance tests (e.g. presence of a prior fragility fracture)
• conditions that would not allow the participant to get into the therapy pool (e.g. wounds, fear of water)
• currently attending physiotherapy or supervised exercise.

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead
• Toronto Rehabilitation Institute: collaborator

Central Study Contacts

Anna Ogonowska-Slodownik

CONTACT

+1 (416) 597-3422; anna.ogonowskaslodownik@awf.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2024-12