Clinical trial NCT05207215: Study on the Steps to Avoid Falls in the Elderly
Official title: Use of Video Consultation, Computer Gaming and Self-help Home Exercises as Steps to Avoid Falls in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Fall Prevention
Pre- Frail
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
name: Sengkang General Hospital
First posted: 2022-01-26
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential multiple assignment randomized trial.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: To monitor the change of SPBB over the study period
timeFrame: Baseline, 3rd month and 9th month
Secondary outcomes:
measure: Patient Demographic Profile
timeFrame: Baseline, 3rd month and 9th month
measure: Profile of the Caregiver
timeFrame: Baseline, 3rd month and 9th month
measure: Health Status: Presence of diseases
timeFrame: Baseline, 3rd month and 9th month
measure: Health Status: Lawton IADL
timeFrame: Baseline, 3rd month and 9th month
measure: History & Attitude Towards Falls
timeFrame: Baseline, 3rd month and 9th month
measure: Social Network & Social Isolation
timeFrame: Baseline, 3rd month and 9th month
measure: Healthcare Utilisation
timeFrame: Baseline, 3rd month and 9th month
measure: Quality of Life Characteristics
timeFrame: Baseline, 3rd month and 9th month
measure: Compliance of the different Intervention
timeFrame: Baseline, 3rd month and 9th month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
state: State *
Study officials:
affiliation: SingHealth Services
name: Celia IC Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References: