Table 2.
An overview of variables and outcomes, outcome measures, instruments and time point for the assessment
Outcome | Outcome measures | Instrument | Time point |
---|---|---|---|
Descriptive variables | |||
Personal information | Age, gender, former job, marital status, educational background and chronic diseases | Self-report | T3 |
Depression | The Major Depression Inventory (MDI) [39] | T3 | |
Incontinence | International Consultation on Incontinence Questionnaire (ICIQ) [40] | T3 | |
Eating ability | Self-reported dental state | T3 | |
The Eating Symptom Questionnaire [41] | |||
The EAT-10 Questionnaire [42] | |||
Simplified Nutritional Appetite Questionnaire [43] | |||
Primary outcome | |||
Muscle power | Lower leg muscle power | The Nottingham Leg Rig [44–46] | T3 and T5 |
Secondary outcomes | |||
Muscle mechanical function | Countermovement jump | The countermovement jump is performed on a force platform (Kistler 9281 B, 40 × 60 × 5 cm) following the procedure described in [47]. Four maximal jumps will be performed with 1-min interval and the highest jump recorded | T3 and T5 |
Maximal muscle strength | Leg press | Assessed on the dominant leg in a custom-built unilateral leg press device with a fixed footplate instrumented with piezoelectric force transducers (Kistler 9367/8 B). The force signals will be digitally sampled at 1 kHz while on-line visual feedback is provided to the subject. The contractile rate of force development and impulse will be determined in the trial with the highest resultant peak force [44, 48] | T3 and T5 |
Handgrip strength | Handgrip strength is measured using a handheld dynamometer (Original Smedley’s Daynameter, Scandidact, 100 kg, Cat. No. 281128). Participants are instructed to sit with the elbow at a 90° angle, the wrist in neutral position. The inner lever of the dynamometer is adjusted to the hand of the participants (the second phalanxes against the lever) (Andersen-Ranberg et al. 2009). A minimum of three contractions in each hand will be performed and testing continues until participant produce less force than the prior test. | T3 and T5 | |
Physical Frailty Status |
The SHARE-FI75+ Fried frailty phenotype |
The SHARE-FI75+ is a physical frailty assessment tool that is developed specifically for community-dwelling adults aged ≥ 75 years [5] | T3 and T5 |
Fried frailty phenotype consists of five variables where three are based on questions: (i) unintentional weight loss, (ii) self-reported exhaustion, and (iii) low energy expenditure and the remaining two are based on objective assessment: (iv) slow gait speed and (v) weak hand grip strength [9]. The variable ‘low energy expenditure’ is modified to follow the current recommendations on physical activity in older adults from the World Health Organization [49]. | |||
Risk of malnutrition | Protein intake | The Protein Screener Pro55+ is used to assess the risk of poor protein intake [35] | T1, T2, T3 and T5 |
Four days food records (filled out on three weekdays and one day during the weekend) are calculated (Winfood 4.1) to estimate the average protein intake (g) per kg body weight per day and protein content per meal. In addition, energy intake and distribution of macronutrients are calculated. | |||
Weight loss | Self-reported unintentional weight changes during the last month | T1, T2, T3, T4, and T5 | |
Nutritional status | The Eating Validation Scheme (EVS) is composed of five questions about dietary intake and weight loss and three questions about risk factors (dysphagia, eating assistance, and acute illness) [50] | T3 and T5 | |
The Mini Nutritional Assessment (MNA) is composed of 18 questions and measurements concerning appetite, eating ability, weight, need for help, illness, and medication [51] | |||
Anthropometry | Weight | Measured in light clothes, without shoes and subtracting 0.5 kg for the weight of clothes using a calibrated TANITA scale (model DC430SMA) | T3 and T5 |
Waist- and Hip- circumference | Following the protocol by the World Health Organization [52] | ||
Height | Measured without shoes | T3 | |
Body composition | Estimation of fat mass, fat-free mass and bone mass | Dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy) scans will be used to assess whole body composition with special emphasis on lean mass and fat tissue as well as bone mineral density. | T3 and T5 |
Foot-to-foot bioelectrical impedance analysis (BIA), using the TANITA Total Body Composition Analyzer (model DC430SMA). | |||
Physical function and mobility | Gait speed, Chair stand, Balance | The Short Physical Performance Battery (SPPB) [53] | T3 and T5 |
Rising from laying position on the floor and stand and reach test [54] | |||
Self-selected and maximal gait speed (10 m) [55–57] | |||
Distance walked during 2 min [58, 59] | |||
Physical activity level | Objective measures of intensity, duration, and patterns of physical activity and sedentary behavior | Hip-worn accelerometers, ActiGraph (removed during sleep) | T3 and T5 |
Thigh-worn accelerometers, Axivity (24 h/day) | |||
Data will be continuously collected in a raw format at 30/50 Hz, respectively, over a period of 7 days. | |||
Self-reported sedentary behavior | The Sedentary Behavior Questionnaire (SBQ) [60] | T3 and T5 | |
Activities of daily living | Self-report | Questionnaire that combines items from the Most Efficient Lists and the Short-Form of Late-Life Function and Disability Instrument [61–63] | T3 and T5 |
Pain, fatigue, and fatigability | Self-report | The Brief Pain Inventory - Short Form (BPI-sf) [64] | T3 and T5 |
The Mobility fatigue scale “Mob-T” [65] | |||
The Pittsburgh Fatigability Scale (PFS) for older adults (only the domain about physical fatigue will be assessed) [66] | |||
Fear of falling | Self-report | The Falls Efficacy Scale – International (FES-I) [67] | T3 and T5 |
Self-reported falls within the last year | |||
Cognitive function | Pencil and paper test | The Digit Symbol Substitution Test (DSST) [68, 69] | T3 and T5 |
Health-related quality of life | Self-report | The EQ-5D-3L questionnaire [70] | T3 and T5 |
Biomarkers | Blood sample | Biomarkers related to nutritional status, physical activity, sedentary behavior, as well as physical and cognitive function—such as lipids, hormones, proteins, cytokines, vitamins, and minerals, e.g., cholesterol, HbA1c, adiponectin, suPAR, Crp, IL-6, B12 and vitamin D, vitamin B12 [71–74] | T3 and T5 |
T1 time of enrolment, T2 post the stabilization phase, T3 baseline pre-intervention, T4 half-way follow-up, T5 close-out post-intervention