Effect of Home Exercise on Reducing Falls

Fall Clinical Trial

Official title:

The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599934
• Other study ID #: 2017.400
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: October 2, 2021

Study information

• Verified date: November 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.

Description:

This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• aged 60 or older

• able to ambulate with a Functional Ambulation Category (FAC) score = 3

• able to walk for = 10 meters

• history of falls in the past 12 months

• living in the community

• without MCI or dementia according to the 5-minute Montreal Cognitive assessment

• have a moderate fall risk or above as assessed by the Physiological Profile Assessment

• able to understand Chinese.

Exclusion Criteria:

• blindness

• diagnosis of mental disorders (e.g., severe depression, schizophrenia)

• any contraindications to exercise (e.g. unstable angina).

Related Conditions & MeSH terms

• Fall

Intervention

Other:
• Lifestyle integrated functional exercise program
Lifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months.
• Home safety assessment
Home safety assessment and modification that targets to reduce environmental risk factors of falls.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Hong Kong	The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall	Prospective fall data will be collected through telephone follow-up for 1.5 year	1.5 years
Secondary	Handgrip strength	Hand grip strength will be assessed by handheld dynamometer	Baseline and follow-up assessment at 6-month
Secondary	Functional lower body strength	Five-time sit-to-stand test will be used to assess lower body strength	Baseline and follow-up assessment at 6-month
Secondary	Single leg standing balance	Single leg standing balance of both legs will be assessed	Baseline and follow-up assessment at 6-month
Secondary	10-meter walk test	The usual walking speed on a 10-meter walkway	Baseline and follow-up assessment at 6-month
Secondary	Timed-up and Go test	The time required to stand up from a chair, walk 3-m, return, and sit down, in comfortable speed	Baseline and follow-up assessment at 6-month
Secondary	Timed-up and Go test with dual-task	The timed-up and Go test would be tested while asking the participants to do serial-3-subtraction	Baseline and follow-up assessment at 6-month
Secondary	Montreal Cognitive Assessment 5-minute protocol	A standardized cognitive test	Baseline and follow-up assessment at 6-month
Secondary	Activity level	Selected participants will be asked to wear an activity tracker for 7 days to examine their activity level	Baseline and follow-up assessment at 6-month
Secondary	Fall risk	Physiological Profile Assessment (PPA) will be used to assess fall risk	Baseline and follow-up assessment at 6-month