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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Invitation-only

Conditions

Fall

Treatments

Behavioral: upper limb exercise training
Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)

Study type

Interventional

Funder types

Other

Identifiers

NCT05694494
2020.622-T

Details and patient eligibility

About

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.

Full 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).

Enrollment

322 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

322 participants in 2 patient groups, including a placebo group

iLiFE
Experimental group
Description:
receiving Lifestyle-integrated Functional Exercise training and home safety assessment
Treatment:
Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)
attention control
Placebo Comparator group
Description:
upper limb exercise training
Treatment:
Behavioral: upper limb exercise training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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