Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)

NCT ID: NCT05694494

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-11-01

Brief Summary

Falls are the second leading cause of unintentional injury and death around the globe. About one in every three older adults falls each year worldwide. With the aging population, the cost of treating fall-related injuries is increasing exponentially. There is a pressing need for a cost-effective fall prevention program. Ample evidence has shown the substantial standalone effectiveness of well-designed physical exercises in preventing falls. However, continuous exercise adherence is required for a long-lasting fall prevention effect. Unfortunately, adherence to an exercise program was generally only 21%. Building up the habit of doing regular exercise is thus crucial in preventing falls. Lifestyle integrated Functional Exercise program (LiFE) has been shown to be able to reduce the fall rate by 31% and maintain 64% of the participants exercising at 12 months follow-up. This proposed randomized controlled trial aims at comparing the effectiveness of an internet-based LiFE in reducing subsequent falls and promoting exercise adherence in community-dwelling older adults.

Detailed Description

All subjects will then be randomly assigned to receive either an internet-based therapist-led LiFE program with a home environment safety assessment (iLiFE) or attention control intervention. Randomization into block groups of four in a 1:1 ratio (the iLiFE group or the attention control group) will be generated in a password-protected excel file by independent research personnel not involved in data collection or intervention after the baseline assessment. The randomization will be concealed by the independent personnel. Research assistants who are blinded to the group allocation will conduct all the subsequent monthly surveillance and assessments at baseline and follow-up sessions. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).

Conditions

Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iLiFE

receiving Lifestyle-integrated Functional Exercise training and home safety assessment

Group Type: EXPERIMENTAL

internet-based Lifestyle-integrated Functional Exercise (iLiFE)

Intervention Type: BEHAVIORAL

receiving internet-based LiFE training and home safety assessment

attention control

upper limb exercise training

Group Type: PLACEBO_COMPARATOR

upper limb exercise training

Intervention Type: BEHAVIORAL

upper limb exercise training

Interventions

internet-based Lifestyle-integrated Functional Exercise (iLiFE)

receiving internet-based LiFE training and home safety assessment

Intervention Type: BEHAVIORAL

upper limb exercise training

upper limb exercise training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• aged ≥ 65 years,
• community-dwelling,
• have a fall history in the previous 12 months,
• have a moderate or above risk of falls as assessed by the Physiological Profile Assessment (total z-score ≥ 1)
• can ambulate on level surfaces without physical contact of another person as assessed by Functional Ambulation Category (score ≥ 3)
• cognitively intact as assessed by the Hong Kong version of the Montreal Cognitive Assessment-5-minute protocol (score ≥ 16th percentile of the age and education-adjusted cut-off score)
• able to communicate effectively.

Exclusion Criteria

• uncorrected vision or hearing impairment,
• unstable medical condition that may preclude the planned exercises, and
• have been receiving or planning to receive any fall prevention program within the study period.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Timothy Kwok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Kwok

Role: PRINCIPAL_INVESTIGATOR

The Chinese Univsersity of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2020.622-T

Identifier Type: -

Identifier Source: org_study_id