3 Protocol for the In Balance randomized controlled trial | 43 Fried et al. (29). Table 3.1 lists the in- and exclusion criteria including the operationalization for each criterion. Potential participants will be excluded if they participated in a fall prevention intervention in the past 6 months, if they are unable to read and understand Dutch, if they have cognitive impairment defined as a score < 19 on the Mini-Mental State Examination (104), or if they have any self-reported uncontrolled comorbid conditions or contraindications for conducting physical exercises during the In Balance intervention (e.g., cardiovascular, neurological and orthopaedic problems). Table 3.1. Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Adults aged ≥ 65 years Classified as non-frail or pre-frail based on the phenotype concept introduced by Fried et al. (weight loss, weak grip strength, exhaustion, slow gait speed and low physical activity) (29) Living in a community-based setting Having a potential fall risk, as assed by the fall risk screening questionnaire (145-147) Able to independently execute activities of daily living and walk 100 meter Cognition < 19 points on the Mini-Mental State Examination (104) Not able to read or understand Dutch Participation in a fall prevention programme in the past 6 months Self-reported contra-indications for participation in the In Balance intervention Frailty status Frailty status will be determined at baseline based on the frailty indicators according to Fried and colleagues (29). The frailty phenotype includes weight loss, weak grip strength, exhaustion, slow gait speed and low physical activity (29). Weight loss is assessed by self-reported, unintentional weight loss of 5 kilogram or more in the last year (29). Grip strength will be assessed using a handheld dynamometer and is calculated as the average of three measurements of the score in kilogram of the dominant hand (148). Original cut-off points stratified by sex and body mass index will be used to indicate weak grip strength (29). Exhaustion is considered present if a participant has a score < 75 on the vitality subscale of the 36-Item Short Form Health Survey (149). Gait speed will be assessed by recording the time in seconds to walk 4 meter at usual pace; slow gait is defined using predefined cut-off points, converted to a 4 meter distance, stratified by sex and height (29). Last, low physical activity will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF) and is defined as burning less than 383 or 270 kilocalories with physical activity per week for men and women, respectively (29, 150). Participants will be considered as non-frail if they meet none of the criteria and classified as pre-frail when meeting 1 or 2 of the criteria. If participants meet 3 or more of the criteria, they will be classified as frail and will be excluded from this study (29).
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