Clinical trial NCT04801316: Steady Feet: Proof of Value
Official title: Steady Feet: Proof of Value
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Community-dwelling Older Adults
Fall Risk
Keywords: Exercise
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Detailed description: There will be two parts to this study, part 1: a feasibility study, and part 2: a randomised controlled trial (RCT).

The aim of part 1 is to evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the Steady Feet (SF) classes.

Part 1 comprises a pre-post design and qualitative methods. Community instructors' competency levels of class execution will be compared before and after the video-facilitated training. Interviews or focus group discussions will be conducted for community providers, instructors, and community-dwelling older adults to explore the acceptability, appropriateness, feasibility of the exercise video, and to obtain feedback and any recommendations for improvements. This part of the study aims to recruit 30 participants.

The aim of part 2 is to examine the effectiveness of the SF Programme on improving functional outcomes in older adults (aged 60 years and above) with a high risk of falls.

Part 2 comprises an open-label, parallel randomized controlled trial. At least 260 participants (130 intervention and 130 control) with a Short Physical Performance Battery (SPPB) score of 7 to 10, no significant cognitive impairment and vision issues will be recruited to be part of the study. Participants will be randomized to the intervention or control group before the baseline visit and will be followed-up prospectively at the 3rd month, and 6th month. Repeated measures will be performed at the pre-defined time points. The primary outcome of interest is the difference in Short Performance Physical Battery (SPPB) scores between the intervention and control groups at 6 months. Intention to treat analysis will be used. Other outcomes, such as functional assessments, balance confidence, fear of falling, quality of life, healthcare utilisation, and cost, and fall history will also be examined.

Eligibility criteria: Part 1:

Community providers or instructors will be eligible if they meet all the following inclusion criteria:

* Male or female aged 21 years and older
* Are involved in the planning or implementation of the exercise programme

Community-dwelling participants will be eligible if they meet all the following inclusion criteria during screening:

* 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:

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Part 1: Changes from pre-competency checklist scores
timeFrame: Pre (prior to the video training), post (immediately after the video training)
measure: Part 2: Changes from baseline Short Performance Physical Battery (SPPB) scores
timeFrame: Baseline, 3rd month, and 6th month
Secondary outcomes:
measure: Part 2: Changes from baseline ConfBAL scale scores
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline Fear of Falling scores
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline EQ-5D-5L scores
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline injurious falls
timeFrame: Baseline, and 6th month
measure: Part 2: Incremental healthcare utilisation and costs over the study period
timeFrame: 3rd month, and 6th month
Other outcomes:
measure: Part 2: Changes from baseline Single Leg Stance (SLS) timing
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline Four Square Step Test (FSST) timing
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline Timed Up and Go (TUG) timing
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline 30 second chair stand test (30CST)
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline 6-minute walk test (6MWT) distance
timeFrame: Baseline, 3rd month, and 6th month
measure: Changes from baseline Borg Rate of Perceived Exertion (RPE) scores
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Changes from baseline Global Physical Activity Questionnaire (GPAQ) scores
timeFrame: Baseline, 3rd month, and 6th month
measure: Part 2: Participant's satisfaction survey (3rd month)
timeFrame: 3rd month
measure: Part 2: Participant's satisfaction survey (6th month)
timeFrame: 6th month
measure: Part 2: Provider satisfaction survey
timeFrame: 3rd month
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Dr. Low Shou Lin
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.