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Table 4 Follow-up analysis (Intent to treat), Total Patient Number = 117

From: A pilot randomized controlled trial to improve geriatric frailty

Characteristics

EN (N = 55)

Non-EN (N = 62)

p-value‡

PST (N = 57)

Non-PST (N = 60)

p-value‡

n (%).mean ± sd†

n (%) mean ± sd†

n (%)mean ± sd†

n (%) mean ± sd†

Frailty-related Characteristics

Improvement of CHS_PCF characteristics§

      

Weight loss (yes)

      

 Improvement at 3-month

9 (16)

6 (10)

0.277

7 (12)

8 (13)

0.838

 Improvement at 6-month

8 (15)

8 (13)

0.761

6 (11)

10 (17)

0.329

 Improvement at 12-month

11 (20)

9 (15)

0.400

8 (14)

12 (20)

0.372

Exhaustion (yes)

      

 Improvement at 3-month

16 (29)

17 (27)

0.824

16 (28)

17(28)

0.968

 Improvement at 6-month

17 (31)

18(29)

0.806

16 (28)

19 (42)

0.666

 Improvement at 12-month

19 (35)

20 (32)

0.769

16 (28)

23 (38)

0.328

Low activity level (yes)

      

 Improvement at 3-month

2(4)

4 (6)

0.495

3(5)

3(5)

0.926

 Improvement at 6-month

2 (4)

4 (6)

0.495

3 (5)

3 (5)

0.926

 Improvement at 12-month

2(4)

4 (6)

0.495

3(5)

3 (5)

0.926

Slowness (yes)

      

 Improvement at 3-month

6 (11)

2 (3)

0.126

5 (9)

3 (5)

0.423

 Improvement at 6-month

4 (7)

3 (5)

0.585

6 (11)

1 (2)

0.085

 Improvement at 12-month

6 (11)

3 (5)

0.232

7 (12)

2 (3)

0.090

Weakness (yes)

      

 Improvement at 3-month

11 (20)

17 (27)

0.346

17 (30)

11 (18)

0.135

 Improvement at 6-month

9 (16)

16 (26)

0.218

9 (16)

16 (27)

0.170

 Improvement at 12-month

7 (13)

17 (27)

0.055

12 (21)

12 (20)

0.837

Health-Related Characteristics

MMSE

      

 Change at 12-month

−0.15 ± 2.53

0.06 ± 2.52

0.658

−0.05 ± 2.35

−0.02 ± 2.69

0.954

PRIME-MD

      

 Change at 3-month

−0.96 ± 2.92

−1.29 ± 4.50**

0.631

−1.32 ± 3.64*

−0.97 ± 4.03

0.603

 Change at 6-month

−0.05 ± 2.84

−0.65 ± 4.03

0.356

−0.42 ± 2.96

−0.32 ± 4.00

0.846

 Change at 12-month

−0.16 ± 3.17

−0.77 ± 3.65

0.327

−0.77 ± 3.27

−0.22 ± 3.58

0.365

Barthel Index

      

 Change at 3-month

1.09 ± 3.81*

1.53 ± 4.11**

0.520

1.05 ± 3.98*

1.58 ± 3.96**

0.458

 Change at 6-month

0.36 ± 2.33

0.73 ± 4.78

0.597

0.88 ± 4.13

0.25 ± 3.50

0.354

 Change at 12-month

0.55 ± 2.99

0.89 ± 3.68

0.617

0.88 ± 3.29

0.58 ± 3.46

0.655

EQ-5D

      

 Change at 3-month

0.02 ± 0.08

0.03 ± 0.08*

0.632

0.01 ± 0.09

0.03 ± 0.08**

0.162

 Change at 6-month

−0.004 ± 0.12

0.004 ± 0.12

0.738

0.0001 ± 0.09

0.001 ± 0.14

0.980

 Change at 12-month

0.01 ± 0.09

0.02 ± 0.10

0.455

0.01 ± 0.07

0.02 ± 0.11

0.534

Healthcare-resource utilization

      

 Change at 3-month

0.04 ± 1.36

−0.35 ± 2.70

0.353

−0.07 ± 1.67

−0.27 ± 2.58

0.650

 Change at 6-month

0.60 ± 1.81

0.03 ± 2.55

0.186

0.42 ± 1.74

0.18 ± 2.65

0.589

 Change at 12-month

0.05 ± 1.8

0.03 ± 2.44

0.984

0.39 ± 2.05

−0.28 ± 2.25

0.104

Body Composition, and Musculoskeletal System Characteristics

BMI (kg/m2)

      

 Change at 12-month

−0.31 ± 1.19*

−0.18 ± 1.05

0.572

−0.36 ± 1.15*

−0.13 ± 1.08

0.280

FFM (kg)

      

 Change at 12-month

−0.46 ± 1.36*

−0.62 ± 1.84**

0.587

−0.59 ± 1.30**

−0.50 ± 1.90*

0.726

Compression Fracture form Spine X-ray

      

 12-month

55(100)

58(94)

0.137

54 (95)

59(98)

0.518

BMD (T-score)∥ (N = 115)

      

12-month

      

 > −1

14(26)

7(11)

0.042

11(20)

10(17)

0.770

 ≦ −1

39(74)

55(89)

 

45(80)

49 (83)

 

Left one leg stand time (sec) (N = 111)

      

 Change at 3-month

2.86 ± 9.19*

0.92 ± 9.01

0.268

2.38 ± 8.91

1.34 ± 9.34

0.553

 Change at 6-month

2.57 ± 8.39*

1.81 ± 8.47

0.683

3.10 ± 8.93*

1.30 ± 7.84

0.298

 Change at 12-month

3.69 ± 9.15**

3.43 ±9.15**

0.906

4.31 ± 10.23***

2.84 ± 7.92*

0.399

Dominant leg extension power (kg)

      

 Change at 3-month

3.06 ± 7.13**

1.72 ± 6.6*

0.330

3.42 ± 7.36***

1.33 ± 6.32

0.102

 Change at 6-month

1.48 ± 5.9

1.35 ± 7.00

0.986

2.71 ± 6.08**

0.18 ± 6.68

0.035

 Change at 12-month

−6.44 ± 10.08***

−4.44 ± 8.59***

0.217

−3.52 ± 9.65**

−7.14 ± 8.74***

0.036

Blood Examination

25(OH) Vitamin D (ng/mL) (N = 109)

      

 Change at 12-month

4.85 ± 7.69***

1.19 ± 5.41

0.006

3.4 ± 7.80***

2.49 ± 5.85**

0.633

  1. *P-value < 0.05, ** p-value < 0.01, *** p-value < 0.001 for the comparison of the value at the follow-up time with the baseline value within the group, as calculated with the use of linear mixed model.
  2. †:Categorical data:n (%);Continuous variables:mean ± sd.
  3. ‡: Intervention effect, controlling for the other treatment strategy, follow up time and treatment-by-follow up time interactions. Categorical data:generalized estimating equations (GEE);Continuous variables:linear mixed model. P-values for compression fracture form spine XRAY and BMD from logistic regression model with exact modification when appropriate.
  4. §:After intervention 3, 6 and 12 months[CHS_PCF]has progressed from[yes]to[no].
  5. ¶:Emergency room visits, hospitalizations, or clinic visits in the past 3 months.
  6. ∥:The minimum T-score of either the femoral neck or the spinal mean at L2–L4.
  7. BMD:Bone Mineral Density, BMI: Body mass index, CHS_PCF: Cardiovascular Health Study_Phenotypical Classification of Frailty, EN:Exercise and Nutrition, EQ-5D:EuroQol Quality of Life Scale, FFM: Fat Free Mass, MMSE: Mini-Mental State Examination, PRIME-MD: Primary Care Evaluation of Mental Disorders, PST: Problem Solving Therapy.