Steady Feet: Proof of Value

Fall Risk Clinical Trial

Official title:

Steady Feet: Proof of Value

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04801316
• Other study ID #: SFPOV2021
• Status: Terminated
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Community-dwelling Older Adults
• Fall Risk

Intervention

Behavioral:
• Steady Feet exercise programme
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.
• Steady Feet Video
About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part 2: Changes from baseline Single Leg Stance (SLS) timing	Time measured in participants while standing without using support, and with one foot off the ground.	Baseline, 3rd month, and 6th month
Other	Part 2: Changes from baseline Four Square Step Test (FSST) timing	Time taken to move in a pre-determined sequence through four squares.	Baseline, 3rd month, and 6th month
Other	Part 2: Changes from baseline Timed Up and Go (TUG) timing	Time taken to rise from a seated position, walk 3 metres forth and back, and return to a seated position.	Baseline, 3rd month, and 6th month
Other	Part 2: Changes from baseline 30 second chair stand test (30CST)	Number of stands from a seated position within 30 seconds	Baseline, 3rd month, and 6th month
Other	Part 2: Changes from baseline 6-minute walk test (6MWT) distance	Distance covered while walking back and forth along a 10 metres course in 6 minutes.	Baseline, 3rd month, and 6th month
Other	Changes from baseline Borg Rate of Perceived Exertion (RPE) scores	The RPE is used to measure a participant's effort and exertion, breathlessness, and fatigue before and after the 6MWT.	Baseline, 3rd month, and 6th month
Other	Part 2: Changes from baseline Global Physical Activity Questionnaire (GPAQ) scores	A measure of physical activity levels developed by the World Health Organisation (WHO). It captures physical activity levels in 3 domains (at work, travelling between places, recreational activities), and sedentary behaviours.	Baseline, 3rd month, and 6th month
Other	Part 2: Participant's satisfaction survey (3rd month)	A self-developed survey to obtain participants' feedback on the exercise programme. It captures participants satisfaction ratings on the instructor, exercises, exercise venue, and effect felt after the class.	3rd month
Other	Part 2: Participant's satisfaction survey (6th month)	A self-developed survey to obtain participants' feedback on the exercise programme. It captures information on whether participants are still exercising, and feedback on the programme as a whole.	6th month
Other	Part 2: Provider satisfaction survey	A self-developed survey to obtain providers' feedback (individuals who are responsible for the implementation and execution of the programme) on the programme.	3rd month
Primary	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)
Primary	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	Part 2: Changes from baseline ConfBAL scale scores	A scale that consists of 10 activities. Participants will rate their confidence level in completing each activity without losing their balance. There are 3 ratings available: "not confident = 3 points", "slightly confident = 2 points", and "confident = 1 point". Ratings are summed to form a total score.	Baseline, 3rd month, and 6th month
Secondary	Part 2: Changes from baseline Fear of Falling scores	A visual analogue scale, ranging from 0 to 10 that measures the participant's fear of falling, with 0 indicating "not afraid" of falling, and 10 indicating "Extremely" afraid of falling.	Baseline, 3rd month, and 6th month
Secondary	Part 2: Changes from baseline EQ-5D-5L scores	A measure of quality of life. It comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	Baseline, 3rd month, and 6th month
Secondary	Part 2: Changes from baseline injurious falls	Participants will be asked questions on their history of falls within the last 6 months, location of falls, and any injuries associated with the falls.	Baseline, and 6th month
Secondary	Part 2: Incremental healthcare utilisation and costs over the study period	Participants will be asked questions on their healthcare utilisation, the associated costs, and whether it was fall-related.	3rd month, and 6th month