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

NCT05694494 | Enrolling By Invitation

• 1 other identifier: 2020.622-T
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Outcome Measures

Primary Outcomes (1)

• fall incidence as assessed by monthly telephone or internet follow-up

  12 months

Secondary Outcomes (13)

• physiological fall risk as assessed by the Physiological Profile Assessment (PPA)

  4 months

• balance as assessed by the 4-stage stance

  4 months

• balance as assessed by functional reach tests

  4 months

• mobility as assessed by the Short Physical Performance Battery Test

  4 months

• mobility as assessed by the Timed Up and Go Test

  4 months

Study Arms (2)

iLiFE

EXPERIMENTAL

receiving Lifestyle-integrated Functional Exercise training and home safety assessment

Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)

attention control

PLACEBO COMPARATOR

upper limb exercise training

Behavioral: upper limb exercise training

Interventions

internet-based Lifestyle-integrated Functional Exercise (iLiFE) BEHAVIORAL

receiving internet-based LiFE training and home safety assessment

iLiFE

upper limb exercise training BEHAVIORAL

upper limb exercise training

attention control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Study Officials

• Timothy Kwok

  The Chinese Univsersity of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 23, 2023
• Study Start: May 2, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)