NCT06210828

Brief Summary

  • The purpose of this study is to assess the effectiveness of telerehabilitation for fall prevention.
  • Participants are randomly assigned to telerehabilitation group or control group.
  • Both the telerehabilitation and control groups will receive fall prevention education.
  • In addition, both groups will receive a fall prevention exercise brochure that includes instructions on how to perform the exercises, the recommended repetition and number of sets.
  • The telerehabilitation group engages in two exercise sessions per week for a duration of 12 weeks at home. The session will be led by a physical therapist via telerehabilitation (LINE video call).
  • All participants are advised to perform exercise for a total 3 days/week and record in the log book.
  • Participants are evaluated for balancing abilities using tests including: Timed Up and Go test, Five times chair stand, Single leg stance, Gait speed, Number of fall at 3 month, 6 month, 1 year.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 8, 2024

Last Update Submit

January 21, 2024

Conditions

Keywords

Physical PerformanceFallingElderlyTelerehabilitationTelerehabTelemedicineExerciseTelehealth

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go test

    time taken to rise from a chair, walk a 3-meter distance, turn around, walk back and sit down

    1 year

Secondary Outcomes (3)

  • Five times chair stand

    1 year

  • Single leg stance

    1 year

  • Gait speed

    1 year

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

A telerehabilitation group participates in two weekly exercise sessions over a 12-week period at home. These sessions, led by a physical therapist through two-way communication, focus on lower extremity strengthening and balance exercises. In addition to the guided sessions, participants are encouraged to perform self-directed exercises one day per week.

Behavioral: Telerehabilitation

Control Group

ACTIVE COMPARATOR

* Receive fall prevention exercise brochure that includes instructions on how to perform the exercises, the recommended repetition and number of sets. * Participants are suggested to perform self-directed exercises three day per week.

Behavioral: Control

Interventions

Two weekly exercise sessions over a 12-week period at home via LINE Video call with physical therapist. Focusing on lower extremity strengthening and balance exercises. In addition to the guided sessions, participants are encouraged to perform self-directed exercises one day per week.

Telerehabilitation Group
ControlBEHAVIORAL

Receive fall prevention exercise brochure

Control Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly aged ≥ 60 years walking independently with or without gait aid use
  • Had a history of falling at least 1 time within the past year.
  • Participants or their caregivers have an ability to use telemedicine (LINE video call), read and understand a brochure.

You may not qualify if:

  • Those who have unstable medical conditions influenced their gait and mobility such unstable cardiopulmonary problem, non-heal fracture and severe arthritis and a cognitive impairment limited learning ability to exercise will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (17)

  • Clark RD, Lord SR, Webster IW. Clinical parameters associated with falls in an elderly population. Gerontology. 1993;39(2):117-23. doi: 10.1159/000213521.

    PMID: 8514201BACKGROUND
  • Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.

    PMID: 27707740BACKGROUND
  • Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.

    PMID: 11322678BACKGROUND
  • Kwak CJ, Kim YL, Lee SM. Effects of elastic-band resistance exercise on balance, mobility and gait function, flexibility and fall efficacy in elderly people. J Phys Ther Sci. 2016 Nov;28(11):3189-3196. doi: 10.1589/jpts.28.3189. Epub 2016 Nov 29.

    PMID: 27942147BACKGROUND
  • Kuptniratsaikul V, Praditsuwan R, Assantachai P, Ploypetch T, Udompunturak S, Pooliam J. Effectiveness of simple balancing training program in elderly patients with history of frequent falls. Clin Interv Aging. 2011;6:111-7. doi: 10.2147/CIA.S17851. Epub 2011 May 6.

    PMID: 21594001BACKGROUND
  • Zhuang J, Huang L, Wu Y, Zhang Y. The effectiveness of a combined exercise intervention on physical fitness factors related to falls in community-dwelling older adults. Clin Interv Aging. 2014;9:131-40. doi: 10.2147/CIA.S56682. Epub 2014 Jan 10.

    PMID: 24453483BACKGROUND
  • Leslie S, Tan J, McRae PJ, O'leary SP, Adsett JA. The Effectiveness of Exercise Interventions Supported by Telerehabilitation For Recently Hospitalized Adult Medical Patients: A Systematic Review. Int J Telerehabil. 2021 Dec 16;13(2):e6356. doi: 10.5195/ijt.2021.6356. eCollection 2021.

    PMID: 35646230BACKGROUND
  • Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.

    PMID: 30324099BACKGROUND
  • Peretti A, Amenta F, Tayebati SK, Nittari G, Mahdi SS. Telerehabilitation: Review of the State-of-the-Art and Areas of Application. JMIR Rehabil Assist Technol. 2017 Jul 21;4(2):e7. doi: 10.2196/rehab.7511.

    PMID: 28733271BACKGROUND
  • Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23.

    PMID: 30366759BACKGROUND
  • Ranaweera AD, Fonseka P, PattiyaArachchi A, Siribaddana SH. Incidence and risk factors of falls among the elderly in the District of Colombo. Ceylon Med J. 2013 Sep;58(3):100-6. doi: 10.4038/cmj.v58i3.5080.

    PMID: 24081169BACKGROUND
  • Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

    PMID: 24484314BACKGROUND
  • Tiedemann A, Shimada H, Sherrington C, Murray S, Lord S. The comparative ability of eight functional mobility tests for predicting falls in community-dwelling older people. Age Ageing. 2008 Jul;37(4):430-5. doi: 10.1093/ageing/afn100. Epub 2008 May 16.

    PMID: 18487264BACKGROUND
  • Chang CJ, Chang YS, Yang SW. Using single leg standing time to predict the fall risk in elderly. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:7456-8. doi: 10.1109/EMBC.2013.6611282.

    PMID: 24111469BACKGROUND
  • Hong C. Gait Speed Cut-Off Point as a Predictor of Fall in Community-Dwelling Older Adults: Three-Year Prospective Finding from Living Profiles of Elderly People Surveys in Korea. KJFP 2016;6:105-110.

    BACKGROUND
  • Kis O, Buch A, Stern N, Moran DS. Minimally supervised home-based resistance training and muscle function in older adults: A meta-analysis. Arch Gerontol Geriatr. 2019 Sep-Oct;84:103909. doi: 10.1016/j.archger.2019.103909. Epub 2019 Jul 8.

    PMID: 31301519BACKGROUND
  • Ninlerd C, Dungkong S, Phuangphay G, Amornsupak C, Narkbunnam R. Effect of home-based rehabilitation exercise program for elderly patients with femoral neck fracture after bipolar hemiarthroplasty. Siriraj Med J. 2020; 72(4): 307-14

    BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • INTOUCH AMPHAIPHAN

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intouch Amphaiphan, MD

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

November 1, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations