Accepted Manuscript

Early nutritional support and physiotherapy improved long-term self-sufficiency inacutely ill older patients

Petra Hegerová, MD Zuzana Dědková, MD Prof. Luboš Sobotka, MD, PhD

PII: S0899-9007(14)00349-9

DOI: 10.1016/j.nut.2014.07.010

Reference: NUT 9346

To appear in: Nutrition

Received Date: 20 January 2014

Revised Date: 2 July 2014

Accepted Date: 5 July 2014

Please cite this article as: Hegerová P, Dědková Z, Sobotka L, Early nutritional support andphysiotherapy improved long-term self-sufficiency in acutely ill older patients, Nutrition (2014), doi:10.1016/j.nut.2014.07.010.

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EARLY NUTRITIONAL SUPPORT AND PHYSIOTHERAPY IMPROVED

LONG-TERM SELF-SUFFICIENCY IN ACUTELY ILL OLDER PATIENTS

Running head:

Nutrition and Physiotherapy against Sarcopenia

Authors:

• Petra Hegerová, MD (3rd Department of Medicine, Medical faculty and Faculty Hospital

Hradec Kralove, Charles University in Prague, Czech Republic) – main author,

corresponding author

• Zuzana Dědková, MD (3rd Department of Medicine, Medical faculty and Faculty Hospital

Hradec Kralove, Charles University in Prague, Czech Republic) - coauthor

• Prof. Luboš Sobotka, MD, PhD. (3rd Department of Medicine, Medical faculty and Faculty

Hospital Hradec Kralove, Charles University in Prague, Czech Republic) - coauthor

Word count: 4251

Adress: petra.hegerova@fnhk.cz

Faculty of medicine in Hradec Králové , 3rd Department of Medicine, Faculty Hospital, Sokolská 581,

Hradec Kralove 500 05, Czech Republic

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Abstract

Objective: An acute disease is regularly associated with inflammation, decreased food intake

and low physical activity; the consequence is loss of muscle mass. However, the restoration of

muscle tissue is problematic especially in older patients. Loss of muscle mass leads to further

decrease of physical activity which leads, together with recurring disease, to the progressive

muscle mass loss accompanied by loss of self-sufficiency. Early nutrition support and

physical activity could reverse this situation. Therefore the aim of our study was to determine

whether an active approach based on early nutritional therapy and exercise may influence the

development of sarcopenia and impaired self-sufficiency during acute illness.

Methods: Two hundred patients older than 78 years and admitted to the internal medicine

department participated in a prospective, randomized and controlled study. They were

randomized between a control group (standard treatment n = 100) and an intervention group

(n = 100). The intervention consisted of nutritional supplements (600 kcal, 20 g protein a day)

added to standard diet and a simultaneous intensive rehabilitation program. The tolerance of

supplements and their influence on spontaneous food intake, self-sufficiency, and muscle

strength and body composition were evaluated during the study period. The patients were then

regularly monitored for 1 year after discharge.

Results: The provision of nutritional supplements together with early rehabilitation led to

increased total energy and protein intake while the intake of standard hospital food was not

reduced. The loss of lean body mass and decrease in self-sufficiency were apparent at

discharge from hospital and 3 months thereafter in the control group. These alterations were

prevented by the nutritional and rehabilitation program in the study group. A positive effect of

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nutritional intervention and exercise during hospital stay was apparent till the 6th month after

discharge from the hospital.

Conclusions: The early nutritional intervention together with early rehabilitation preserves

muscle mass and independence in acutely ill older patients hospitalized because of acute

disease.

Key Words: self-sufficiency, nutrition, lean body mass, elderly

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Introduction

Due to improved medical care the life expectancy is increasing; according to data from

Eurostat database EU-27 it reaches 76.7 years for men and 82.6 years for women in the

European Union. However, the aging process is very often accompanied by a loss of

independence and the subsequent requirement for help from near relatives or community. In

some old subjects almost one quarter of their lifetime is spent in conditions of disability. The

reason for this decline is apparently complex; especially weakening of the somatic condition

due to accumulation of chronic and degenerative diseases, gradual decline of mental function

and loss of skeletal muscle mass, are together responsible for loss of independence. The

deficit of muscle mass is usually both a permanent and continual process associated with

aging1. However, this does not mean, that muscle wasting is an inevitable part of the aging

process. More likely it is a cumulative result of recurring subsequent acute disease; this is

because the subsequent restoration of physical improvement and muscle mass needs more

time and is very difficult and often impossible in older subjects2. This situation results in

continuing but progressive decrease of muscle mass and subsequent loss of self-sufficiency

with a requirement for institutionalization of some older patients in hospitals or nursing

homes.

Acute illness is regularly associated with an inflammatory reaction that is essential both

for disease survival and for subsequent regeneration and recovery. Metabolic reactions

connected with inflammation are characterized by increased energy expenditure and changes

in substrate metabolism3, which results in mobilization of body protein especially from

skeletal muscle4. Extensive skeletal muscle catabolism is apparently essential for delivery of

energy and other indispensable substrates, in resolution of the acute disease3,5; however, it

finally leads to a significant loss of body musculature. Moreover, a reduction of physical

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activity due to immobilization, and negative energy and protein balance resulting from

decreased food intake contribute to the additional loss of skeletal muscles during acute illness.

Nutrition problems are common in older subjects6 and they are associated with the

mentioned catabolic factors during acute disease or surgery. The etiology of malnutrition

principally involves factors that may be changed and influenced; insufficient food intake is

central in this aspect. Forty four percent of institutionalized older subjects did not eat enough

energy to meet the recommended intakes in one Spanish study7. In a Turkish study, poor

nutritional status was found in 44% of older patients admitted to the clinic in one year (13%

malnutrition, 31% at risk from malnutrition according to the MNA test)8. In a Belgian study

which included 2329 older hospitalized patients, 33% of patients suffered from malnutrition,

almost 43% were at risk from malnutrition and only 24% were well-nourished9. Moreover,

insufficient nutritional intake is often combined with a history of acute or current chronic

disease – the so-called disease-related malnutrition10.

A quantity of skeletal muscle mass is essential for the recovery from acute illness. A

positive relationship was shown between muscle strength and clinical outcome in patients

after liver transplantation in a recent meta-analysis11. Skeletal muscle is source of substrates

essential for disease survival and the healing process as well as for the subsequent period of

recovery. The remaining muscle mass is also crucial for salvation of life quality after cure of

an acute disease12. As physical activity decreases with age and the amount of muscle mass is

dependent on muscle function, the protein depots are usually lower in seniors. Without

nutrition and adequate physical exercise the skeletal musculature further fades away.

Additionally, during hospitalization for an acute illness, the food intake and physical activity

of a geriatric patient are even more reduced. Significant loss of skeletal muscle mass

(particularly lower extremity) due to 10 days of bed rest was detected in a group of 12 healthy

and moderately active subjects with mean age 67 years)13. The loss of lean tissue was more

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profound in elderly patients after 10 days than in younger subjects after 28 days14. The

decline of protein synthesis and muscle strength due to 14 days of inactivity was counteracted

by moderate-resistance exercise15.

It is obvious that bed rest and physical inactivity lead to decreased muscle mass, muscle

strength and muscle protein synthesis13. It is also known that immobilization combined with

inflammation and undernutrition leads tofurther loss of muscle mass and function; this is

frequent in acutely ill seniors during a hospital stay. Especially those subjects who were able

to perform only moderate physical activity before the onset of the acute illness were prone to

completely lose their self-sufficiency despite only relatively small decreases of skeletal

musculature. The regain of muscle mass and function needs prolonged and complicated

rehabilitation, which is frequently difficult or even impossible in this patient group. Due to

these circumstances an acute disease in the elderly is almost always connected with a loss of

self-sufficiency and increased need for after-care both at home and in after-care institutions.

It has been proven that sip feeding applied in elderly patients may have a positive effect

especially during hospitalization and the acute phase of disease. In a Swiss study the authors

proved that medical patients at nutritional risk profit from nutritional support in terms of

nutritional status, quality of life, complication incidence and repeated hospital admission even

with only short period of hospital stay16. Another intervention study involved 445 hospitalized

older patients, who received normal hospital diet plus either 400 ml of nutritional

supplementor placebo each day for 6 weeks. The results showed that oral nutrition

supplements improved nutritional conditions and led to a statistically significant reduction of

unscheduled re-admissions to hospital17. That is why, especially in geriatric patients, complete

recovery could depend on the nutritional support and early physical activity. However, the

combination of nutritional support and early physiotherapy has not been studied so far.

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The aim of our study was to assess whether it was possible to influence the loss of

muscle mass in acutely ill patients by an active approach based on nutritional support and

early physiotherapy, and thus to extend their self-sufficiency, and improve their quality of

life. Secondary objectives of the project were to determine the tolerance of sipping and its

effect on spontaneous food intake during hospital stay.

Patients and Methods

Inclusion/exclusion criteria

The prospective randomized study was organized at the 3rd Internal Department of

Metabolic Care and Gerontology, FacultyHospital in Hradec Králové. Inclusion criteria were:

age over 78 years, admission to hospital due to acute illness, self-sufficiency of the patient

before admission (Barthel Index18 more than 60), patient´s consent to participation in the

study. Exclusion criteria: terminal stage of disease, terminal organ failure, hospitalization in

the previous three months, or more than 2 hospitalizations in the previous six months,

indication for immediate nutritional support (recent weight loss, reduced food intake – less

than 50% of the normal amount for more than 2 days prior to admission, BMI < 18.5 kg·m2),

low self-sufficiency prior to the acute disease (Barthel Index ≤ 60), advanced stage of

dementia associated with loss of independence , disagreement with participation in the study.

Randomization of the patients and study protocol

Patients selected for the study were randomized by the method of sealed envelopes. The

intervention group (IG) of patients (n = 100) was given nutritional sip supplements from the

1st day of hospitalization together with initiation of physiotherapy. Rehabilitation and

nutritional support continued during the whole hospital stay.

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The control group (CG, n = 100) was treated according to the standard protocol in our

department. The patients received normal hospital diet, and the rehabilitation was initiated

after improvement of the underlying disease. Nutritional support was indicated when patients

were not able to eat an adequate amount of food for more than three days19,20.

Nutritional and rehabilitation intervention

Nutritional supplementation (sipping) was administered to all patients of the

intervention group together with their normal diet from the first day after admission to the

hospital. To prevent interference with normal food intake, the supplement was given to the

patients regularly at 2 PM and 7 PM. throughout the time of their hospitalization. The daily

dosage of energy and protein in supplements was 600 kcal and 20 g respectively.

The rehabilitation intervention was guided by an experienced physiotherapist (from the

Rehabilitation Department of the University Hospital) and commenced on the 2nd day of

hospitalization, 4 times a day, 6 days a week as follows:

a) Training of lower limbs on the bicycle ergometer KineTec Cycle twice a day for 5

minutes. The intensity of the exercise was limited by a maximum increase of heart rate by 15

beats compared with the resting state. During the exercise the patient was sitting on a chair

leaning on the back rest or lying on his back in bed. Training was conducted actively

according to the patient´s condition, with support from his/her movement, or passively. The

heart rate was continuously monitored.

b) Therapeutic physical training and other physiotherapy techniques were performed

twice a day for 15 minutes. The interventions were focused on increase of proprioception,

maintaining joint flexibility, training neuromuscular coordination, support of respiration,

training capability to maintain balance, and gait training. The intervention had a low intensity

(increase of heart rate by a maximum of 15 beats) and was individually tailored to the health

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status of each patient, recorded in the report and then scored according to the exercise

intensity, or according to positions achieved during the intervention (supine – sitting –

standing).

In the control group the rehabilitation took place only for 10 – 15 minutes 5 days a week, as

indicated in the course of patient´s recovery, and the patients did not perform aerobic

exercise.

Time schedule of controls

The patients were assessed at the following intervals:

- 1streview – second day after admission (= Day 1 of study)

- 2ndreview – day of discharge from the hospital

- 3rd - 6threviews 3, 6, 9 and 12 months after discharge

The investigators (P.H. and Z.D.) were responsible for all assessments. The 1st and 2ndreview

was performed during the patients stay in the hospital. Reviews number 3, 4 and 6 were

performed personally in the outpatient clinic of the hospital. During these examinations

morbidity, anthropometry, bioimpedance, and self-sufficiency (Barthel Index, Lawton Index

questionnaires) were assessed. The data from review 5 were received using telephone

interviews (morbidity + self-sufficiency).

Detected values

Age, gender, diagnosis, number of hospitalization days, anthropometry – weight, height

were recorded.

Body composition - lean tissue (LTM) and adipose tissue (FAT) were evaluated by

bioimpedance (by means of BCM Fresenius Medical Care SBJA0607).

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Self-sufficiency was assessed by means of Barthel Index and Lawton Index questionnaires.

Nutritional risk screening was estimated using NRS 200221.

During the entire hospital stay the spontaneous food intake was monitored by nursing staff by

means of daily reports whether none, 1/4, 1/2, 3/4, or all of the serving was wasted - quarter

waste method22. The amount of the sip feed consumed (supplement) was carefully recorded.

Statistical analysis

The number of subjects included in the study was consulted with Department of biophysics and

biostatistics in Faculty of Medicine in Hradec Kralove. It was recommended to include 50 patients in

each group as minimum. We decided to double the number of patients.

Results are expressed as mean ± SD or percentage. Baseline characteristics,

spontaneous food intake and daily intake of energy and protein of both the groups

(intervention and control) were compared using a Student´s unpaired t-test or a Mann-

Whitney test (NCSS 2004). The effect of intervention (changes in body composition and self-

sufficiency) was tested by Mixed Test (NCSS 2007). Statistical tests were considered

significant at the two-sided p < 0.05 level.

Results

During the two year period of the study a total number of 1770 patients was admitted to

the hospital. From these subjects 200 patients were included in the study because they

fulfilled the inclusion criteria and because they were accepted during the time when we could

offer the full research program. The recruitment of the patients finished when all 200 planned

patients were included; 100 patients were randomized to the control group (CG) and 100

patients to the intervention group (IG).

The mean age of participants was 83.2 ± 3.8 years in the CG, 83.6 ± 3.8 in the IG. At the

baseline there were no statistically significant differences between CG and IG except for a

significantly higher BMI in the CG (27.8 ±5.0 vs. 26.4 ± 4.3, P = 0.04). The length of stay

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in hospital for all patients was 11 ± 7 days and there was no difference between CG and IG

(Table 1,2).

Nutrition intake

Nutritional supplementation (sipping) was well tolerated during the whole hospital stay;

the mean amount of actually consumed nutritional supplements was 83.3% of the prescribed

amount (500 kcal and 16.7 g of protein). Moreover, sipping had no effect on spontaneous

intake of hospital food (Table 3); the percentage of hospital food truly consumed by the

patients during the whole stay was 72.8% in the IG and 71.3% in the CG (p=0.528).

The total daily energy and protein intakes were significantly higher in the IG than in the

CG (energy 1954.4± 428.9 and 1401 ± 363.7, respectively, p<0.001 and protein 76.3± 16.1

and 55.5± 13.7 respectively p<0.001).

The total energy deficit during the hospital stay was significantly lower in supplemented

group (-428.3 ± 2720.7 kcal in the IG vs. -6409.0 ± 10227.4 kcal in the CG). A comparable

result was apparent in the cumulative protein deficit (-111.0 ± 221.7 g in IG vs. -352.6 ±

544.8 g in CG) during whole hospital stay.

The body weight and BMI decreased in both groups during their hospital stay.

However, the body weight loss persisted in the CG for another three months after discharge

from hospital and reached its original value only 12 months after discharge from the hospital.

In contrast the IG patients started to regain both their body weight and BMI immediately after

the discharge from the hospital and had achieved their original weight already after 6 months.

The amount of lean body mass (LBM) in the CG decreased during their hospital stay,

and 3 months after discharge from the hospital it was is 3.5kg lower in comparison with that

at the time of admission to the hospital (Table 4, Fig.1). There was an additional decrease

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until the 6th month after the end of the hospital stay, after which it began to increase slightly

again. On the contrary in the IG, the LBM did not change during the hospital stay, and its

value was only 0.4kg lower 3 months after discharge in comparison with value at time of

admission; then it was almost stable till the 6th month, when it began to increase up to month

12 when it reached slightly higher values than at the beginning of the hospital stay. However,

the LBM did not reache the original value even 12 months after discharge from the hospital.

Self-sufficiency (BI) diminished during the course of annual monitoring in both groups

of patients (Table 5). However this decline was sharper in the CG; the compared values of BI

on admission and after 3 months in the CG show a statistically significant decline in self-

sufficiency (p < 0.01) in contrast to a non-significant decline in the IG. A statistically

significant drop (minus 8.5 ± 16.21 points) was also apparent in the CG, whereas it was

milder and statistically insignificant in the IG (5.2 ± 12.46 points sixth month after the end of

hospitalization). A similar trend was detected even after 12 months after discharge from

hospital (10.3 ± 21.6 versus 9.7 ± 19.2 points), however, the difference between groups was

not statistically significant (Fig.2).

Discussion

The loss of skeletal muscle mass is a serious problem in the older population especially

when their life expectancy is growing. This is, inter alia, also because it prolongs the period of

dependence. The economic impact of sarcopeniaand its therapy represent approximately 1.5%

of total health care expenditure in the USA23. These data are especially important in

relationship with the increasing age of the population and the growing number of seniors in

developed countries. Genton et al. showed in a 9-year longitudinal study that loss of body

weight and lean tissues occurs exponentially from the age of about 70 years in healthy

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subjects24. However, the increase in the daily physical activity can limit this loss. The

analysis of 9 studies dealing with the effect of physical activity intervention in acutely

admitted inpatients over 65 years of age showed that elderly patients could benefit from a

multidisciplinary program that included physical intervention25. This included also a reduction

of hospitalization costs by approximately $300 per hospital stay, reduction of hospital stay by

approximately one day, and a 6% increase in numbers of patients discharged to their home

environment. Interestingly however, programs consisting of only practicing exercises did not

show sufficiently good results25.

The results of our prospective randomized study show thatan active approach based on

both early rehabilitation and nutritional supplementation can reduce the negative effects of

acute illness in older patients, perhaps due to prevention of critical loss of muscle mass.

Despite the fact that nutritional support and rehabilitation therapy were applied for a relatively

short time, and to a group of patients in whom (according to actual recommendations) it was

not indicated, the significant difference in the rate of muscle mass decrease between the

intervention and control groups was observed even after 3 – 6 months.

Early nutritional support is important to prevent deterioration of nutritional status. A

meta-analysis including 31 randomized studies of 2464 elderly patients showed a significant

fall in mortality in patients receiving oral nutritional supplementation of complete

composition. Hospitalized patients´ stay in hospital was 3.4 days shorter on average even

though the incidence of complications was not significantly different. Individual studies had a

favorable influence on functional indicators26,27.

Optimal nutrition in conjunction with physical activity can evidently prevent

acceleration of sarcopenia but their combination is not yet well described in the therapy of

elderly patients and therefore is not part of routine care for hospitalized seniors. In our study

we confirmed our hypothesis that properly and timely conducted nutritional and rehabilitation

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intervention in elderly patients with an acute illness moderate the muscle loss, prevent

significant loss of self-sufficiency, and thus help to maintain patients´ higher quality of life.

At the same time it reduces the adverse social and economic impact associated with the lower

self-sufficiency of seniors.

Conclusion

This prospective randomized controlled intervention study shows the positive effect of early

nutritional support and rehabilitation therapy on slowing the loss of self-sufficiency, muscle

mass and strength in acutely hospitalized seniors, thus helping maintain higher quality of life,

and saving costs of subsequent medical and social care.

Acknowledgements

We thank all the physiotherapists from the Rehabilitation Department of the

UniversityHospital in Hradec Králové. The project was supported by research grant

PRVOUK P 37-12

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Figure 1

Lean body mass progress in control and study groups during 3 month periods.

M: months (time period between the discharge and observation)

Figure 2

Barthel index progress in control and study groups during 3 month periods.

M: months (time period between the discharge and observation)

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Table 1

Characteristics of the patients included in the study (no significant differences between groups).

Number of patient

NRS (nutrition risk screening)

Age (years) Weight (kg)

Control group 100 2.22 ± 0.75 83.2 ± 3,8 74.4 ± 14.1

Intervention group

100 2.3 ± 0.61 83.6 ± 3,8 72.3 ± 13.3

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Table 2

Disease characteristics of the patients in the study.

Cardiac disease Infection

Kidney disease + Metabolic

disease

Gastrointestinal disease

Control group

(n = 100) 42 33 11 14

Intervention group

(n = 100)

43 35 14 8

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Table 3

Food intake measured by wasted- quarter-waste method (percentage of served portions)

Food intake Breakfast Lunch Dinner Day

Control group (n = 100)

70.4 ± 21.4 69.2 ± 19.6 71.2 ± 18.8 71.3 ± 18.1

Intervention group

(n = 100) 74.9 ± 17.4 70.0 ± 19.9 73.3 ± 19.5 72.8 ± 17.2

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Table 4

Lean body mass progress of control and study groups during 3 month periods.

M: months (time period between the discharge and observation)

Lean Body Mass

[kg] Admission 3 M 6 M 9 M 12 M

Control group

(n = 100) 30.9 ± 10.9 27.0 ± 6.4 27.4 ± 7.6 26.0 ± 8.1 28.3 ± 7.5

Intervention

group

(n = 100)

30.6 ± 9.1 31.9 ± 8.5 30.2 ± 8.8 29.6 ± 8.5 31.9 ± 9.9

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Table 5

Barthel index progress of control and study groups during 3 month periods.

M: months (time period between the discharge and observation)

* - statistical significant from value on admission

Barthel Index Admission 3 M 6 M 9 M 12 M

Control group

(n = 100) 91.3 ± 10.0 83.2 ± 20.0* 80.6 ± 23.3* 81.0 ± 22.4* 80.0* ± 24.4

Intervention group

(n = 100) 93.2 ± 7.7 88.1 ± 14.3 86.6 ± 15.5 85.5 ± 17.9 83.9* ± 20.3

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Bar

thel

inde

x

80,0

83,9

91,3

83,2

81,080,6

88,186,6

85,5

93,2

70,0

75,0

80,0

85,0

90,0

95,0

Admission 3 M 6 M 9 M 12 MControl Group Intervened Group

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Lean

Bod

y M

ass

[kg]

28,3

31,930,9

27,0 27,4 26,0

30,631,9

29,630,2

0,0

5,0

10,0

15,0

20,0

25,0

30,0

35,0

Admission 3 M 6 M 9 M 12 M

Control group Intervened group

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ACCEPTED

ACCEPTED MANUSCRIPT

Seniors hospitalized due to acute

disease

Control group –standard treatment

Intervention group –nutrition supplement &

exercise

0 3 6 9 1279

84

89

94

Supplement & exercise

Standard treatment

Deg

ree

of in

depe

nden

ce -B

I

Months after discharge from hospital

MANUSCRIP

T

ACCEPTED

ACCEPTED MANUSCRIPT

Highlights:

• 200 old patients (over 78 years) accepted to hospital due to acute illness. • 100 randomly selected patients received nutritional supplements and early

physiotherapy. • Nutritional supplements and early physiotherapy prevented body mass loss and loss of

independence. • The benefit of nutritional support and physiotherapy was obvious even 6 months after

discharge from the hospital.