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Enrolling by Invitation

NCT Number: NCT05694494

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

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.

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Key information

Conditions

Fall

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

internet-based Lifestyle-integrated Functional Exercise (iLiFE)

Behavioral

receiving internet-based LiFE training and home safety assessment

upper limb exercise training

Behavioral

upper limb exercise training

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)

    Time frame: 4 months

    will be done at the baseline- and re-assessments

  2. balance as assessed by the 4-stage stance

    Time frame: 4 months

    will be done at the baseline- and re-assessments

  3. balance as assessed by functional reach tests

    Time frame: 4 months

    will be done at the baseline- and re-assessments

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

    Time frame: 4 months

    will be done at the baseline- and re-assessments

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

    Time frame: 4 months

    will be done at the baseline- and re-assessments

  6. mobility as assessed by the Ten Metre Walk Test

    Time frame: 4 months

    will be done at the baseline- and re-assessments

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

    Time frame: 4 months

    will be done at the baseline- and re-assessments

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

    Time frame: 4 months

    will be done at the baseline- and re-assessments

  9. physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK)

    Time frame: 4 months

    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.

  10. Cognitive flexibility as assessed by Trail Making Test

    Time frame: 4 months

    will be done at the baseline- and re-assessments

  11. balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale

    Time frame: 12 months

    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. exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale

    Time frame: 12 months

    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.

  13. health-related quality of life as assessed by EQ-5D-5L

    Time frame: 12 months

    will be done at the baseline and re-assessment and the last monthly telephone or internet follow-up

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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