Study on the Steps to Avoid Falls in the Elderly

NCT05207215 | Completed

• 1 other identifier: SAFE TRIP
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Fall Prevention; Pre- Frail

Outcome Measures

Primary Outcomes (1)

• To monitor the change of SPBB over the study period

  The SPBB will be captured at 3 time points (1st during the baseline, 2nd during the 3rd month post assessment and 3rd during the 9 month post assessment). Direct measurement will be taken by the assessor.

  Baseline, 3rd month and 9th month

Secondary Outcomes (9)

• Patient Demographic Profile

  Baseline, 3rd month and 9th month

• Profile of the Caregiver

  Baseline, 3rd month and 9th month

• Health Status: Presence of diseases

  Baseline, 3rd month and 9th month

• Health Status: Lawton IADL

  Baseline, 3rd month and 9th month

• History & Attitude Towards Falls

  Baseline, 3rd month and 9th month

Study Arms (4)

Group A: Video Conferencing

ACTIVE COMPARATOR

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.

Other: Home Base Exercises

Group B: Gamification

ACTIVE COMPARATOR

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

Other: Home Base Exercises

Group C: Self Guided

ACTIVE COMPARATOR

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.

Other: Home Base Exercises

Group D: Self Guided

PLACEBO COMPARATOR

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.

Other: Home Base Exercises

Interventions

Home Base Exercises 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 A: Video Conferencing; Group B: Gamification; Group C: Self Guided; Group D: Self Guided

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Sengkang General Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, State *, 169608, Singapore

Location

Study Officials

• Celia IC Tan, PhD

  SingHealth Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential multiple assignment randomized trial.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: January 26, 2022
• Study Start: November 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)