CClinicalTrials.gg
Enrolling by invitationNCT05694494Updated Aug 21, 2024

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

An interventional study of internet-based Lifestyle-integrated Functional Exercise (iLiFE) and upper limb exercise training in Fall, sponsored by Chinese University of Hong Kong. Enrolling by invitation at 1 site in Hong Kong. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
322
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Fall
03

In context

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
322 participants (estimated)

Study arms

  • Experimental
    iLiFE

    receiving Lifestyle-integrated Functional Exercise training and home safety assessment

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

  • Placebo comparator
    attention control

    upper limb exercise training

    Behavioral: upper limb exercise training

Interventions

  • Behavioralinternet-based Lifestyle-integrated Functional Exercise (iLiFE)

    receiving internet-based LiFE training and home safety assessment

  • Behavioralupper limb exercise training

    upper limb exercise training

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

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

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  2. balance as assessed by the 4-stage stance

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  3. balance as assessed by functional reach tests

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  4. mobility as assessed by the Short Physical Performance Battery Test

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  5. mobility as assessed by the Timed Up and Go Test

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  6. mobility as assessed by the Ten Metre Walk Test

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  7. muscle mass as assessed by the Bioimpedance Analysis (BIA)

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  8. postural hypotension as assessed by the blood pressure in sitting and standing

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  9. 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.

    Time frame: 4 months

  10. Cognitive flexibility as assessed by Trail Making Test

    will be done at the baseline- and re-assessments

    Time frame: 4 months

  11. 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.

    Time frame: 12 months

  12. 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.

    Time frame: 12 months

  13. 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

    Time frame: 12 months

07

Study locations

1 site
  • The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05694494
Lead sponsor
Chinese University of Hong Kong
Responsible party
Timothy Kwok (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jan 23, 2023
Start date
May 2, 2023
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Aug 21, 2024

Study contacts

Timothy Kwok
principal investigator · The Chinese Univsersity of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion