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Table 2 An overview of variables and outcomes, outcome measures, instruments and time point for the assessment

From: Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial

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 [44,45,46]

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) [55,56,57]

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 [61,62,63]

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 [71,72,73,74]

T3 and T5

  1. T1 time of enrolment, T2 post the stabilization phase, T3 baseline pre-intervention, T4 half-way follow-up, T5 close-out post-intervention