Study on the Steps to Avoid Falls in the Elderly

NCT ID: NCT05207215

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-07-01

Brief Summary

This study focuses on administering home-based exercises which include balance, strength, endurance, and mobility training to pre-frail subjects via one of the 3 intervention arms. These evidence-based home exercises are performed two times a week for 12 weeks (3 months). A follow-up assessment will be conducted at the end of 9 months after 6 months maintenance phase.

Detailed Description

Falls are the most common morbid and expensive health condition involving older adults. The range of exercises included in the SAFE programme is designed to be adaptable to a wide range of physical functions targeting pre-frail older adults. The exact exercises will vary on the patients' functional status. However, all exercise sessions must include balance exercises that challenge the patient's balance during static activities, during movement and also may include challenges as the patient has divided attention (walking and talking, walking while carrying objects). Balance is first emphasised followed by strengthening exercises of the lower extremities. The improvement in walking, physical activity and endurance, is dependent on the patients' improvement in balance and strength. The overall design of the intervention is to develop and maintain functional mobility by targeting deficiencies in balance, strength, mobility, and endurance.

Despite efforts to provide exercises to improve patients' balance and strength to prevent falls, many do not comply with the programme upon discharge. To address this challenge, the investigators propose to conduct a pilot study that will employ novel approaches, using an evidence-based, person-centred falls prevention intervention (SAFE programme), which is sustainable and cost-effective for the general public in Singapore. These three interventions in the study include video conferencing, newly created exercise games (Gamification) and a self-guided home exercise programme.

A key aspect of the SAFE exercise programme is its simple yet structured series of exercises, with gradual progression, to improve balance, mobility and lower limb strength. It is important that subjects continually challenge themselves during the exercise sessions to promote ongoing improvement in physical function. An exercise stratification grid has been developed to help guide the subjects on the types of exercises and level of intensity, that will be appropriate for them. Performance level (as defined in the stratification grid) should be re-assessed weekly so as to track the progress of the subject i.e. once a subject has achieved the level of the specified exercise in a category, the participants will progress to the next level for the same category. In addition, the subjects will be encouraged to participate in walking both, as much and as far as possible, to improve their functional capacity. Therefore, the SAFE exercises are very appropriate to be used in the home setting.

140 pre-frail subjects discharged from SKH, SGH and OCH will be recruited for the study. Only those who meet the requirements criteria using the Ward PT Checklist will be randomised into the 3 intervention groups. All groups are required to exercise at least twice a week and complete the intervention over a 3-month period. Baseline, 3- and 9-months follow-up data will be collected by independent assessors. Outcome measures in 9 categories will be measured and compared across the 3 groups. These measures will be correlated to the subject's compliance to the intervention and effectiveness will be compared between the 3 groups.

Conditions

Fall; Fall Prevention; Pre- Frail

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A: Video Conferencing

Video conferencing is a 2-way interactive session that is enabled using telecommunication networks and the internet. The investigators will be working with 3rd party provider to create the video conferencing platform. Subjects can login to do SAFE exercises while physiotherapists monitor remotely. Subjects will complete two sessions per week (1hour for each session) for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Home Base Exercises

Intervention Type: OTHER

The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.

Group B: Gamification

Gamification refers to exercise-driven gaming, where games are developed with specifications/parameters that incorporate exercise movements. Currently, the investigators have an ongoing pilot study on game-assisted rehabilitation at SGH Physiotherapy Outpatient clinic and the exercise games are developed by an external company. The investigators will engage an external company to develop exercise games based on the exercises used in SAFE programme. Each game will have different difficulty levels to provide progressive training for subjects

Group Type: ACTIVE_COMPARATOR

Home Base Exercises

Intervention Type: OTHER

The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.

Group C: Self Guided

Subjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves.

Group Type: ACTIVE_COMPARATOR

Home Base Exercises

Intervention Type: OTHER

The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.

Group D: Self Guided

Subjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves.

Group Type: PLACEBO_COMPARATOR

Home Base Exercises

Intervention Type: OTHER

The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.

Interventions

Home Base Exercises

The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >= 60 years
• Singapore citizen or Permanent Resident
• With or without fall history in the last one year
• Short Physical Performance Battery (SPPB) >= 6
• Ability to provide informed consent
• Has not more than 1 major comorbidity (Heart attack, heart failure, cerebrovascular disease & cancer)
• Abbreviated Mental Test (AMT) >= 6
• Not referred for further active rehabilitation with a physiotherapist after discharge from hospital or outpatient care.

Exclusion Criteria

• Patients who are advised by their physicians not to participate in physical activity sessions will be excluded from the study.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

Sengkang General Hospital

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celia IC Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

SingHealth Services

Locations

Singapore General Hospital

Singapore, State *, Singapore

Countries

Singapore

Other Identifiers

SAFE TRIP

Identifier Type: -

Identifier Source: org_study_id