A Multi-domain and Multi-component Falls Intervention Program for Community- Dwelling Older Adults: SAFE-TECH

Duke University

Status

Enrolling

Conditions

Fall Injury

Fall Prevention

Treatments

Other: Falls prevention intervention including exercise and educational components

Study type

Interventional

Funder types

Other

Identifiers

NCT06102954

NUS-IRB-2023-496

Details and patient eligibility

About

Background: Falls and fall-related injuries among older adults are a significant health problem that results in injuries, prolonged hospitalisation, reduced mobility, and poorer quality of life. Previous falls prevention programs have demonstrated the effectiveness of multi-component falls prevention interventions in improving functional outcomes and reducing falls compared to usual care. A previous trial of a tailored multi-component falls intervention program for older adults recruited from the emergency department (SAFE) found that there is significant heterogeneity in terms of falls risk factors in high falls risk older adults. Thus, the effectiveness of SAFE in participants with poorer cognitive function or had more comorbidities were less effective and less cost-effective. Therefore, the aim of this trial is to demonstrate the effectiveness of a technology-enhanced, multi-domain and multi-component falls prevention intervention in reducing number of fallers and injurious fallers among older adults with elevated fall risk.

Hypothesis: Using novel wearable technologies to a) identify older adults who are at high risk of falls and more likely to benefit from a multi-component intervention and b) tailor the exercise and educational components by giving individualized biofeedback will improve the effectiveness of an enhanced multi-domain, multi-component falls intervention program for community dwelling older adults.

Methodology: This study is a randomized controlled trial aimed at demonstrating the effectiveness of a technology-enhanced, multi-domain and multi-component falls prevention intervention (SAFE-TECH) in community- dwelling older adults with elevated fall risk compared with usual care. Participants in both arms are selected based on questionnaire based and wearable sensor based predictions of their falls risk. Participants in the intervention arm will receive a 12-week active falls intervention program consisting of exercise and educational components, with detailed biofeedback of their functional status.

Full description

Objective: To demonstrate the feasibility and effectiveness of a technology-enhanced multi-domain, multi-component falls intervention program consisting of screening, assessments, progressive physical therapy and education to reduce falls and injurious falls in community-dwelling older adults in Singapore.

Methodology: This study is a multi-center, two-arm, parallel group, randomized controlled trial with 400 participants allocated to the intervention and control arm in a 1:1 ratio. In the intervention arm, participants will be enrolled in a multi-domain, multi-component falls intervention program that consists of exercise and educational components for 12 weeks. The exercise components are progressive and tailored to individual falls risk factors. Exercises aim to improve 5 domains of physical function: strength, balance, flexibility, coordination, and aerobic endurance. The educational components focus on the management of fall risk factors such as polypharmacy, nutrition, pain, orthostatic hypotension, poor vision, and environmental hazards. The education sessions also provide feedback based on individualized falls risk assessments. After the 12-week active intervention phase, the participants in the intervention arm will enter a 9-month maintenance phase where they will be encouraged to maintain their physical activity, and continue practicing falls prevention behavior.

The study will collect information from both intervention and control arm on their living situation, cognitive function, quality of life, general health, falls history, behavioral and psychosocial characteristics, handgrip strength, orthostatic hypotension, ankle mobility, physical function (Short Performance Physical Battery) and gait assessment (ZurichMOVE system of wearable gait sensors) at baseline, 3rd-months and 12th-months into the study. Monthly follow-up calls will be done to collect participants' fall status, healthcare utilisation, physical activity, and exercise self- efficacy over the 12-month period.

Enrollment

400 estimated patients

Sex

All

Ages

60 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 60 to 95 years
Ambulatory with or without walking aid
Does not possess cognitive impairment with an Abbreviated Mental Score-Singapore >=6

Exclusion criteria

Had any significant morbidity:
- Congestive Heart Failure in the past 6 months
- Myocardial Infarction in the past 6 months
- Stroke (Intra-Cranial Haemorrhage) in the past 6 months
- Concussion or Head Injury in the past 6 months
- End Stage Renal Failure requiring dialysis
- Severe Asthma or Chronic Obstructive Pulmonary Disease (COPD) (e.g. Chronic Lung Disease or Chronic Bronchitis or Emphysema), experiencing symptoms at rest or with mild activity
- Lower Limb Fractures in the past 6 months
Blindness, with or without the use of any visual aids
Deafness, with or without the use of any hearing aids
Currently experiencing one of the following:
- Chest discomfort, or
- Breathlessness, or
- Dizziness, or
- Profuse sweating
Had an amputation of any part of the lower limbs except toes, or had an amputation of any toes in the last 30 days
Currently in a long-term institution
Currently participating in any randomized clinical or controlled trial that involves physical exercise
Unwilling to complete the baseline gait assessment, or complete less than 3 minutes of the 5-minute baseline gait assessment