In Balans: the (cost-)effectiveness of a fall prevention intervention on falls and fall injuries in community-dwelling older adults with an increased risk of falls.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26195

Enrollment

256

Registered

2020-10-02

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ageing and fall risk

Interventions

'In Balans' is a 14-week group exercise programme, with the aim to reduce falls by increasing awareness, balance and strength in older (pre-frail) individuals at risk of falling. The first four weeks

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: - community-dwelling older adults - aged 65 years or older - have an increased risk of falls according to the fall risk assessment (VeiligheidNL)

Exclusion criteria

Exclusion criteria: Exclusion criteria : - are younger than 65 years of age - have no increased risk of falls according to the fall risk assessment (VeiligheidNL) - are not able to independently take care of themselves (e.g. going to the bathroom, dressing and undressing) and walk 100 meter - are not able to read or understand Dutch - have participated in a fall prevention program in the past 6 months - have indications for severe cognitive impairment (MiniMental State Examination < 19/30) - meet 3 or more out of 5 physical frailty criteria, according Fried ea. (2001) and as used by Faber ea. (2006): 1) Weight: Body Mass Index <18.5 kg/m^2 (as a measure for unintentional weight loss) 2) Weakness: Sex and body mass specific grip strength 3) Exhaustion: SF-36 vitality score < 75 4) Slowness: sex and height specific gait speed 5) Low physical activity: SQUASH questionnaire

Design outcomes

Primary

Measure	Time frame
The number of falls (with or without injury) as assessed through fall calendars and monthly telephone calls during 12 month follow up.	—

Secondary

Measure	Time frame
Performance based physical functioning - Balance measured with the ‘Performance-Oriented Mobility Assessment – Balance’, the ‘Four Stage Balance Test’ and the ‘Timed Up and Go Test’ - Mobility measured with the ‘Performance-Oriented Mobility Assessment – Mobility’ - Muscle Strength measured with the ‘Hand Grip Strength Test’ and the ‘Timed Chair Stands Test’ - Walking Speed measured with the ’10 Meter Walk Test’ - Aerobic Endurance measured with the ‘2-minute Step Test’ - Fall Risk measured with the LASA Fall Risk Questionnaire - Daily Physical Activity and Gait Pattern based on Inertial Sensors, worn on the lower back for the duration of a week Questionnaires - General Health Status with the “Short Form Health Survey - SF-36’ and ‘Positive Health Inventory Tool’ - Empowerment with the ‘Pearlin Mastery Scale’ and ‘General Self-Efficacy Scale’ - Fear of Falling with the ‘Falls Efficacy Scale International -FES-I’ - Walking Confidence with the ‘Modified Gait Efficacy Scale -mGES’ - Causes (behavioural, biological, environmental), circumstances and consequences (none, minor, moderate, major) of falls occurring during follow up, with the fall calendar and monthly telephone calls. Secondary economic outcome measures (assessed at M4, M8, M12) are: - Quality of Life assessed with the ‘EuroQol 5D’. - healthcare, and patient and family costs: the iMTA Medical Cost Questionnaire (iMCQ) with a recall period of 4 months - productivity costs: the the iMTA Productivity Cost Questionnaire (iPCQ) with a recall period of 4 months Demographic measures are collected at MO and M12: Age, Sex, Height, Weight, Body Mass Index, Marital status, Living Situation, Education, History of Falls and Fall Injuries, Dizziness, Use of Walking Aids, Vision, History of Fall Prevention Programs, Physical Functioning, Physical Activity, Usage of Medication and Presence of Chronic Diseases. Frailty Status will be assessed based on the ‘Groningen Frailty Indicator- GFI’ and ‘5 Frailty Indicators’: weig	—

Measure

Time frame

Performance based physical functioning - Balance measured with the ‘Performance-Oriented Mobility Assessment – Balance’, the ‘Four Stage Balance Test’ and the ‘Timed Up and Go Test’ - Mobility measured with the ‘Performance-Oriented Mobility Assessment – Mobility’ - Muscle Strength measured with the ‘Hand Grip Strength Test’ and the ‘Timed Chair Stands Test’ - Walking Speed measured with the ’10 Meter Walk Test’ - Aerobic Endurance measured with the ‘2-minute Step Test’ - Fall Risk measured with the LASA Fall Risk Questionnaire - Daily Physical Activity and Gait Pattern based on Inertial Sensors, worn on the lower back for the duration of a week Questionnaires - General Health Status with the “Short Form Health Survey - SF-36’ and ‘Positive Health Inventory Tool’ - Empowerment with the ‘Pearlin Mastery Scale’ and ‘General Self-Efficacy Scale’ - Fear of Falling with the ‘Falls Efficacy Scale International -FES-I’ - Walking Confidence with the ‘Modified Gait Efficacy Scale -mGES’ - Causes (behavioural, biological, environmental), circumstances and consequences (none, minor, moderate, major) of falls occurring during follow up, with the fall calendar and monthly telephone calls. Secondary economic outcome measures (assessed at M4, M8, M12) are: - Quality of Life assessed with the ‘EuroQol 5D’. - healthcare, and patient and family costs: the iMTA Medical Cost Questionnaire (iMCQ) with a recall period of 4 months - productivity costs: the the iMTA Productivity Cost Questionnaire (iPCQ) with a recall period of 4 months Demographic measures are collected at MO and M12: Age, Sex, Height, Weight, Body Mass Index, Marital status, Living Situation, Education, History of Falls and Fall Injuries, Dizziness, Use of Walking Aids, Vision, History of Fall Prevention Programs, Physical Functioning, Physical Activity, Usage of Medication and Presence of Chronic Diseases. Frailty Status will be assessed based on the ‘Groningen Frailty Indicator- GFI’ and ‘5 Frailty Indicators’: weig

—

Contacts

Public ContactMaaike van Gameren

Vrije Universiteit Amsterdam

m.van.gameren@vu.nl+31 20 59 85627

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)