NCT03599934

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

July 16, 2018

Last Update Submit

November 17, 2021

Conditions

Fall

Keywords

ElderlyExerciseFallHome safety

Outcome Measures

Primary Outcomes (1)

  • Fall

    Prospective fall data will be collected through telephone follow-up for 1.5 year

    1.5 years

Secondary Outcomes (9)

  • Handgrip strength

    Baseline and follow-up assessment at 6-month

  • Functional lower body strength

    Baseline and follow-up assessment at 6-month

  • Single leg standing balance

    Baseline and follow-up assessment at 6-month

  • 10-meter walk test

    Baseline and follow-up assessment at 6-month

  • Timed-up and Go test

    Baseline and follow-up assessment at 6-month

  • +4 more secondary outcomes

Study Arms (2)

LiFE training and home safety assessment

EXPERIMENTAL

The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment

Other: Lifestyle integrated functional exercise programOther: Home safety assessment

Control group

NO INTERVENTION

The control group will continue their usual daily routine.

Interventions

Lifestyle integrated functional exercise programOTHER

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.

LiFE training and home safety assessment
Home safety assessmentOTHER

Home safety assessment and modification that targets to reduce environmental risk factors of falls.

LiFE training and home safety assessment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • blindness
  • diagnosis of mental disorders (e.g., severe depression, schizophrenia)
  • any contraindications to exercise (e.g. unstable angina).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Timothy Kwok, MD

    The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 26, 2018

Study Start

July 18, 2018

Primary Completion

November 10, 2020

Study Completion

October 2, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

HK(2)