Steady Feet: Proof of Value

NCT04801316 | Terminated

• 1 other identifier: SFPOV2021
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

It is well established that poorer functional performance is associated with falls in older adults. Exercise is shown to be an effective evidence-based intervention in improving functional performance. However, there is a lack of a specially tailored structured exercise intervention in Singapore to address this. In response, a 6-months community-based structured exercise programme, called "Steady Feet" (SF) was developed. It aimed to improve physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls. Concurrently, COVID-19 led to reduced training and exercise opportunities. There is now a need for alternatives to aid in the training of community instructors, and to carry out exercise programmes for community-dwelling older adults. Thus, the objectives of this study are to examine (1) evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the SF classes. (2) Evaluate the effects of the SF programme (intervention group) on functional status among older adults (aged 60 years and above), compared with a group of older adults that did not participate in the SF programme (control group).

Conditions

Community-dwelling Older Adults; Fall Risk

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• Part 1: Changes from pre-competency checklist scores

  The competency checklist covers 25 different exercise steps during class execution. Trainers (physiotherapists and exercise physiologists) will indicate a "tick" if the trainee has accurately demonstrated the steps as taught during the video-facilitated training.

  Pre (prior to the video training), post (immediately after the video training)

• Part 2: Changes from baseline Short Performance Physical Battery (SPPB) scores

  The SPPB is a series of assessments used to evaluate lower extremity function. It consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4 metres gait speed test, and a chair stand test. Scores of each component are summed to form a total SPPB score.

  Baseline, 3rd month, and 6th month

Secondary Outcomes (5)

• Part 2: Changes from baseline ConfBAL scale scores

  Baseline, 3rd month, and 6th month

• Part 2: Changes from baseline Fear of Falling scores

  Baseline, 3rd month, and 6th month

• Part 2: Changes from baseline EQ-5D-5L scores

  Baseline, 3rd month, and 6th month

• Part 2: Changes from baseline injurious falls

  Baseline, and 6th month

• Part 2: Incremental healthcare utilisation and costs over the study period

  3rd month, and 6th month

Other Outcomes (10)

• Part 2: Changes from baseline Single Leg Stance (SLS) timing

  Baseline, 3rd month, and 6th month

• Part 2: Changes from baseline Four Square Step Test (FSST) timing

  Baseline, 3rd month, and 6th month

• Part 2: Changes from baseline Timed Up and Go (TUG) timing

  Baseline, 3rd month, and 6th month

Study Arms (3)

Part 1: Video training

OTHER

Participants will undergo the following procedures: Community instructors (involved in the training itself): * Attend a video-facilitated training * Be assessed for competency level of class execution before and after the video-facilitated training * Might need to conduct or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week) * Might need to participate in one interview/discussion which will last up to 2 hours Community-dwelling older adult or community providers (individuals involved in the programme implementation but not the training itself): * Attend or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week) * Participate in one interview/discussion which will last up to 2 hours

Behavioral: Steady Feet Video

Part 2: Exercise Intervention

EXPERIMENTAL

Participants will participate in 6 months of exercises, and be provided with education and advice on how to reduce their risk of falls. The exercises are divided into 2 phases: 1. The Steady Feet (SF) exercise programme phase. A twice-weekly tailored structured group exercise class will be conducted for 3 months with community instructors and exercise video. 2. A 3 months maintenance exercise phase. A once-weekly structured community group exercise class.

Behavioral: Steady Feet exercise programme

Part 2: Control

NO INTERVENTION

Participants will be provided with the usual education and advice on how to reduce their risk of falls.

Interventions

Steady Feet exercise programme BEHAVIORAL

Steady Feet (SF) is a 6-month community-based structured exercise programme aimed at improving physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls. This exercise programme was developed by Changi General Hospital's physiotherapists and exercise physiologist from evidence found in the literature.

Part 2: Exercise Intervention

Steady Feet Video BEHAVIORAL

About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme

Part 1: Video training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 21 years and older
• Are involved in the planning or implementation of the exercise programme
• Aged 60 years and older
• SPPB score: 7 to 10
• Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
• Does not possess significant cognitive impairment (AMT ≥ 5)
• Part 2:
• Aged 60 years and older
• SPPB score: 7 to 10
• Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
• Does not possess significant cognitive impairment (AMT ≥ 5)

You may not qualify if:

• Male or female aged \< 60 years old
• SPPB score of ≥ 11 or ≤ 6
• Did not pass at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
• Possess significant cognitive impairment (AMT \< 5)

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

Related Publications (6)

• Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.

  PMID: 24387140 BACKGROUND

• Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.

  PMID: 21632004 BACKGROUND

• Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.

  PMID: 28202383 BACKGROUND

• Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

  PMID: 22972103 BACKGROUND

• Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, Meschi T, Maggio M. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019 Oct;31(10):1435-1442. doi: 10.1007/s40520-018-1082-y. Epub 2018 Dec 4.

  PMID: 30515724 BACKGROUND

• Ong RHS, Nurjono M, Jumala J, Teo RCC, Png GK, Tan PC, Kee MN, Oh HC, Wee MK, Kan KLM, Farhana Binte Rosle L, Lien CTC, Low SL. A community-based single fall prevention exercise intervention for older adults (STEADY FEET): Study protocol for a randomised controlled trial. PLoS One. 2022 Oct 20;17(10):e0276385. doi: 10.1371/journal.pone.0276385. eCollection 2022.

  PMID: 36264909 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dr. Low Shou Lin

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Part 1 of the study is a pre-post non-randomised study with qualitative methods. Part 2 is an open-label, parallel randomized controlled trial.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 17, 2021
• Study Start: November 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)