Clinical trial NCT06720974: AquaReBal - Water-based Reactive Balance Training for Older Adults: a Randomized Pilot Study
Official title: AquaReBal - Water-based Reactive Balance Training for Older Adults: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults, Balance
Older People
Aquatic Physical Exercise
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
Collaborators: name: Toronto Rehabilitation Institute
First posted: 2024-12-06
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 and will be randomized to two groups, the water-based RBT and the land-based RBT. Both groups will receive training 2 times per week for 6 weeks. An initial sample of 30 participants will be randomly assigned to one of the two groups and will be followed for 6 months after the intervention. 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.

Detailed description: Background and Importance: Falls are the second leading cause of unintentional injury deaths worldwide, mostly in older adults. In 2018 falls in Canada had a higher total cost than any other cause of injury. Injuries resulting from a fall are a leading cause of hospitalizations among Canadian adults aged \> 65 years. Recent clinical practice guidelines for older adults identified reactive balance training (RBT) and aquatic therapy as research priorities for fall prevention. There is evidence that RBT almost halves the rate of falls in daily life and improvements in reactive balance control are maintained even up to a year after the end of the program. When RBT is conducted on land, some adverse events (e.g. fear of falling and joint pain) occur. The water environment could minimize the limitations and barriers associated with land-based RBT. To date, there is a lack of studies reporting on the feasibility of conducting RBT in water for reactive balance control in older adults.

Goal(s) / Research Aims: Primary aim is to assess the feasibility of conducting a definitive randomized controlled trial (RCT) to determine the effectiveness of a water-based RBT compared to a land-based RBT.

Specific objectives are to:

1. Evaluate feasibility of water-based RBT according to indicators of process, resources, management and safety;
2. Obtain a preliminary estimate of effect of the water-based RBT compared to land-based RBT on falls rate, reactive balance control and secondary outcome measures;
3. Explore perceptions of program characteristics, program implementation and study procedures among older adults.

Methods / Approaches / Expertise: A parallel group (water-based and land-based RBT) feasibility randomized trial with a qualitative component, prospective recruitment, concealed group allocation and masked evaluator will be conducted among older adults. Participants will be recruited from the Greater Toronto Area. The interventions will be held twice per week for 6 weeks, 60 minutes per session. We will assess feasibility measures (indicators for process, resources, management, and safety parameters), reactive balance control and secondary outcome measures - history of falls, Physical Activity Scale for the Elderly (PASE), Activities-Specific Balance Confidence (ABC) Scale, European Quality of Life Instrument (EQ-5D), Mini Balance Evaluation Systems Test (mini-BESTest), Timed Up and Go (TUG) test. Participants' number of falls after intervention (6 weeks) until 6-month follow-up period will be monitored. Semi-structured interviews (qualitative component) will be conducted to understand the experiences of the participants with the interventions. Primary and secondary outcome measures will again be collected at 6 months post-intervention. The core research staff will consist of experts in the field of aquatic therapy and reactive balance. To facilitate knowledge translation after this study, we have adopted an integrated knowledge translation approach, including a patient partner and a knowledge user early in the preparation of this application and planning stages for the study.

Expected Outcomes: The proposed project will result in the development of a novel water-based RBT. It will inform the design of a definitive RCT to determine whether RBT will be feasible to be applied in the water. In addition, the participants' perspectives on the RBT training in water can provide further information on the feasibility of such interventions.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment to the end of treatment at 6 weeks and at 6 months post intervention
Secondary outcomes:
measure: Falls monitoring
timeFrame: From enrollment to the end of treatment at 6 weeks and 6 months post intervention
measure: The Mini Balance Evaluation Systems Test (mini-BESTest)
timeFrame: From enrollment to the end of treatment at 6 weeks and 6 months post intervention
measure: Timed Up and Go (TUG)
timeFrame: From enrollment to the end of treatment at 6 weeks and at 6 months post intervention
measure: Physical activity
timeFrame: From enrollment to the end of treatment at 6 weeks and at 6 months post intervention
measure: Psychological consequences
timeFrame: From enrollment to the end of treatment at 6 weeks and 6 months post intervention
measure: Health-related quality of life
timeFrame: From enrollment to the end of treatment at 6 weeks and 6 months post intervention
measure: Reactive balance control
timeFrame: From enrollment to the end of treatment at 6 weeks and 6 months post intervention
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