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Study on the Steps to Avoid Falls in the Elderly

Use of Video Consultation, Computer Gaming and Self-help Home Exercises as Steps to Avoid Falls in the Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05207215
Acronym
SAFETRIP
Enrollment
104
Registered
2022-01-26
Start date
2020-11-01
Completion date
2022-07-01
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Fall Prevention, Pre- Frail

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.

Interventions

OTHERHome 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.

Sponsors

Duke-NUS Graduate Medical School
CollaboratorOTHER
Sengkang General Hospital
CollaboratorOTHER
Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Sequential multiple assignment randomized trial.

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To monitor the change of SPBB over the study periodBaseline, 3rd month and 9th monthThe 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.

Secondary

MeasureTime frameDescription
Profile of the CaregiverBaseline, 3rd month and 9th monthThis profile will be collected via an Interview
Health Status: Presence of diseasesBaseline, 3rd month and 9th monthThis information will be collected via an interview
Health Status: Lawton IADLBaseline, 3rd month and 9th monthThis information will be collected via an interview
History & Attitude Towards FallsBaseline, 3rd month and 9th monthThis information will be collected via an interview
Patient Demographic ProfileBaseline, 3rd month and 9th monthThe following will be collected Age, gender, ethnicity, marital status via an interview
Healthcare UtilisationBaseline, 3rd month and 9th monthThe following variables are collected via interview: 1. Number of visits by the participants to the Accident & Emergency Department 2. Number of hospital admissions by the participants 3. Number of visits by the participants to the General practitioner
Quality of Life CharacteristicsBaseline, 3rd month and 9th monthVariables for EQ-5D-5L are collected via interview.
Compliance of the different InterventionBaseline, 3rd month and 9th monthVariables for compliance are being collected via log book and weekly calls.
Social Network & Social IsolationBaseline, 3rd month and 9th monthVariables for Lubben Social Network Scale (LSNS-6) are collected via interview.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026