AquaReBal - Water-based Reactive Balance Training for Older Adults: a Randomized Pilot Study

Józef Piłsudski University of Physical Education

Status: Not yet enrolling

Conditions: Older People; Aquatic Physical Exercise; Older Adults, Balance

Treatments: Other: Land-based RBT; Other: AquaReBal

Study type: Interventional

Funder types: Other

Identifiers

NCT06720974

TorontoRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

AquaReBal - water-based RBT

Experimental group

Description:

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.

Treatment:

Other: AquaReBal

Land-based RBT

Active Comparator group

Description:

Land-based RBT will serve as a dose-matched control group. The training will be conducted using a safety harness that does not support weight but prevents a fall to the ground. Inclusion of a control group in a pilot feasibility study allows for a more realistic examination of recruitment, randomization, implementation of interventions, blinded assessment procedures, and retention.

Treatment:

Other: Land-based RBT