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

Fall Clinical Trial

Official title:

Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE) on Reducing Falls, and Promoting Exercise Adherence in Community Older Fallers: a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05694494
• Other study ID #: 2020.622-T
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 322
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall

Intervention

Behavioral:
• internet-based Lifestyle-integrated Functional Exercise (iLiFE)
receiving internet-based LiFE training and home safety assessment
• upper limb exercise training
upper limb exercise training

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong Jockey Club Centre for 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 incidence as assessed by monthly telephone or internet follow-up		12 months
Secondary	physiological fall risk as assessed by the Physiological Profile Assessment (PPA)	will be done at the baseline- and re-assessments	4 months
Secondary	balance as assessed by the 4-stage stance	will be done at the baseline- and re-assessments	4 months
Secondary	balance as assessed by functional reach tests	will be done at the baseline- and re-assessments	4 months
Secondary	mobility as assessed by the Short Physical Performance Battery Test	will be done at the baseline- and re-assessments	4 months
Secondary	mobility as assessed by the Timed Up and Go Test	will be done at the baseline- and re-assessments	4 months
Secondary	mobility as assessed by the Ten Metre Walk Test	will be done at the baseline- and re-assessments	4 months
Secondary	muscle mass as assessed by the Bioimpedance Analysis (BIA)	will be done at the baseline- and re-assessments	4 months
Secondary	postural hypotension as assessed by the blood pressure in sitting and standing	will be done at the baseline- and re-assessments	4 months
Secondary	physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK)	The participants will be required to wear the device for 7 consecutive days right after the baseline assessment and the re-assessment. Data about the duration of time spent in different activity types such as walking and sitting will be extracted and calculated on a daily basis.	4 months
Secondary	Cognitive flexibility as assessed by Trail Making Test	will be done at the baseline- and re-assessments	4 months
Secondary	balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale	will be done at the baseline assessment, re-assessment, and the last monthly telephone or internet follow-up. The participants will be asked to indicate their level of confidence in performing each activity on a 0-100 scale. A higher score indicates better balance confidence.	12 months
Secondary	exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale	This will be done at the re-assessment and the last monthly telephone or internet follow-up. The total score ranges from 0 to 24. Higher total scores indicate better exercise adherence.	12 months
Secondary	health-related quality of life as assessed by EQ-5D-5L	will be done at the baseline and re-assessment and the last monthly telephone or internet follow-up	12 months