Electronic Supplementary Material
The IDES investigators
Diabetes Centers
1. Diabetes Division, S. Andrea Hospital, Rome: Francesco Fallucca MD; Giuseppe Pugliese MD, PhD; Maria
Cristina Ribaudo MD; Elena Alessi, MD; Paola Simonelli, MD; Laura Salvi, MD, Alessandra Bazuro, MD; Luca
Pugliese, BA; Carla Maccora, BS.
2. Division of Endocrinology and Metabolism, National Geriatric Institute (I.N.R.C.A.), Rome, Felice Strollo MD;
Massimo Morè MD
3. Diabetes Unit, Villa S Pietro Hospital: Pietro Alimonti MD; Nicolina Di Biase MD; Filomena Lasaracina MD
4. Diabetes Unit, City Hospital of Civitavecchia: Graziano Santantonio MD
5. Diabetes Prevention Center (ACISMOM) Latina: Laura Cruciani MD
6. Diabetes Unit, “Triolo Zancla” Clinic, Palermo: Mario Manunta MD
7. Research Center for Physical Activity in Diabetes, University of Catania: Maurizio Di Mauro MD
8. Department of Experimental and Clinical Medicine. University of Catanzaro: Giorgio Sesti MD, Concetta
Irace MD; and Diabetes Unit, City Hospital of Catanzaro: Luigi Puccio MD
9. Division of Endocrinology and Metabolism, University of Foggia: Mauro Cignarelli MD; Vincenzo Nicastro
MD; Sabrina Piemontese MD
10. Diabetes Unit (AID), Provincial Health Authority for Naples1: Gerardo Corigliano MD; Ernesto Rossi MD;
Marco Corigliano MD
11. Department of Internal Medicine,University of Perugia: Pierpaolo De Feo MD;Cristina Fatone MD
12. Diabetes Unit, New Hospital of San Giovanni di Dio, Florence: Cristiana Baggiore MD; Roberto Russo MD
13. Division of Diabetes and Metabolism, National Geriatric Institute (I.N.R.C.A), Ancona: Massimo Boemi MD;
Luigi Lanari MD
14. Diabetes Unit, City Hospital of Brescia: Umberto Valentini MD; Angela Girelli MD
15. Diabetes Unit, City Hospital of Ravenna: Paolo Di Bartolo MD; Francesca Pellicano MD
16. Diabetes Unit, City Hospital of Rimini: Paolo Mazzuca MD
17. Diabetes Unit, City Hospital of Reggio Emilia: Enrica Manicardi MD
18. Diabetes Unit, San G. Battista Hospital, Turin: Alberto Bruno MD
19. Diabetes Unit, “Cà Foncello” Hospital, Treviso: Maria Sambataro MD
20. Diabetes Clinic, Monterotondo, Rome: Stefano Balducci MD
21. Department of Internal Medicine, San Paolo Hospital, University of Milan: Antonio Pontiroli MD; Marco
Laneri MD; Anna Boggio MD
22. Diabetes Unit, Belcolle Hospital, Viterbo: Nunzio Zagari MD
Metabolic Fitness Centers
1. Center for Functional Assessment in Sport, Sant’Andrea Hospital, Rome: Carla Iacobini, Stefano Menini
2. Health Care Team, Monterotondo: Gianluca Balducci, Lorella Senigagliesi, Enza Spinelli
3. Athlos Club, Civitavecchia: Alessandro Di Giovanni
4. Metabolic Fitness, Latina: Mariano Pineda
5. DO-IN, Palermo: Umberto Pandolfo
6. The Wellness Center, Naples: Cristina De Fazio
7. Elisir Club, Perugia: Antonella Settequattrini
8. Metagym, Florence: Marco Gambacciani
9. Fisioclub, Ancona: Matteo Fabrizi
10. Lifeplanet, Ravenna: Adriano Ceccherini, Enrico Balducci
11. Steven Sporting Club, Rimini: Mirko Quattrini
12. Cemter for Physiatrics and Sports Medicine VITALIA, Torino: Massimo Massarini
13. Pianeta sport, Treviso: Giuseppe Baggio
14. Winner Clubs, Reggio Emilia: Marco Fornari
15. Millennium, Brescia: Davide Violi
16. GCube Fitness & Wellness, Viterbo: Giancarlo Cherubini
17. Zenith Center for Medicine, Foggia: Fabio Mastelloni
18. S.S. Free Studios UISP, Catanzaro: Valeria Micali
19. Research Center for Physical Activity in Diabetes, Catania: Carmelo D’Urso
20. Centro “La fonte del benessere”, Milan: Davide Canevari
Management of patients with musculoskeletal problems
A. Exclusion criteria
Patients having any condition severely limiting or contraindicating physical activity (PA) were excluded.
Participants underwent two sequential assessments: general assessment and assessment of physical fitness.
General assessment
At general assessment, identification of the following conditions caused exclusion from the study due to
inability to perform PA/exercise:
1. history of central nervous dysfunction such as hemiparesis, myelopathies, or cerebral ataxia;
2. significant musculoskeletal deformity, such as amputation, scoliosis, dysmetria, or abnormality of range
of motion that would prevent participation (<90° of humeral abduction, inability to grip, <10° of
combined ankle inversion/eversion);
3. presence of arthritis with pain limiting mobility;
4. history or evidence on physical examination of vestibular dysfunction;
5. symptomatic postural hypotension defined as a fall in blood pressure of >20 mm Hg for systolic and/or
>10 mm Hg for diastolic in response to postural change, from supine to standing.
Assessment of physical fitness
Patients not meeting the above criteria underwent the assessment of physical fitness, which included the
following tests:
1. Sub-maximal treadmill test;
2. Strength test of different body segments by means of three exercises:
a.
Push movement on the transverse plane (chest press);
b.
Lateral pull down on the frontal plane;
c.
Leg press.
Patients unable to perform one or more of these tests were excluded from the study.
B. Baseline evaluation of musculoskeletal symptoms
All participants were administered a self-reported questionnaire for musculoskeletal symptoms over the
year preceding the enrollment (Supplemental Table 1), which served as a guide for tailored exercise
prescription in order to improve compliance and minimize the risk of injury and worsening of symptoms.
C. Modification of exercise program
Patients with history of musculoskeletal symptoms during the year preceding the enrollment followed the
standard protocol, though the body segments suffering from these symptoms were exercised with particular
caution.
Conversely, participants suffering from musculoskeletal symptoms at the time supervised training was
started or throughout the 12-month study period followed individualized training programs, which were
designed by the exercise specialist based on the presence, site and extent of symptoms. These programs
excluded temporarily the affected segments at equal exercise volume and intensity until the patient felt able to
move and stretch muscles and had no perception of pain whilst exercising. To this end, exercises involving this
segment were changed with one or more other exercises involving other body segment(s) whilst maintaining
the same volume and intensity of the original program. For example:
1. if a patient suffering from shoulder pain was not able to perform an upper body exercise (movement on
the transverse or frontal plane), he/she was invited to perform an alternative exercise (e.g. squat
movements or trunk flexion) with a number and sets of repetitions as programmed on that week;
2. if a patient suffered from lumbar back, knee or foot pain and, hence, could not perform the
programmed aerobic exercise (e.g. treadmill), he/she was engaged in an upper body ergometer
exercise; similarly, other strength exercises such as squat and trunk flexion were substituted with chest
press or vertical traction respectively, involving the upper body.
Once the patient no longer had pain and/or limited joint mobility in the affected segment, exercise in the
previously painful segment was gradually increased, with concomitant decrease of exercise in previously overutilized segments.
Supplemental Table 1. Self-reported questionnaire for musculoskeletal symptoms over the year preceding the
enrollment
SHOULDER
1
Do you have pain during rotation of the arm ?
2
Are you awakened by pain during the night ?
3
Do you have pain on reaching objects above the head ?
4
Do you have pain on lifting objects ?
5
Do you have pain or soreness upon awakening that passes later on during the day ?
6
Have you taken anti-inflammation drugs or pain-killers ?
ARM
7
Do you feel that you have less strength ?
8
Dou you feel that one arm is weaker than the other ?
9
Do you have pain at the maximum extension of the forearm ?.
ELBOW
10 Do you have pain on lifting an object ?
11 Do you have pain on hitting against a rigid object ?
12 Have you taken anti-inflammation drugs or pain-killers ?
WRIST
13 Do you have pain on lifting an object ?
14 Do you have pain on hitting against a rigid object ?
15 Have you taken anti-inflammation drugs or pain-killers ?
HAND: Do you feel "pins and needles" ? If so, in which finger ?
16 I
17 II
18 III
19 IV
20 V
COLUMN: THORACO-CERVICAL
21 Do you have pain/tenderness/ pins & needles on turning your head from side to side ?
22 Do you often have pain or headache or heaviness of the head or neck ?
23 Do you have pain between the shoulder blades ?
24 Do you feel it necessary to move your head from side to side to get moving and feel ?
25 Do you have episodes of painful sudden acute stiffness of the neck ?
26 Have you taken anti-inflammation drugs or pain-killers ?
COLUMN: LUMBO-SACRAL
27 Do you have pain on bending to tie your shoe laces ?
28 Do you have any back-pain on turning left or right ?
29 Do you have a feeling of heaviness in your back on standing for long hours ?
30 Do you have bothersome feeling when sitting still ? Do you have to get up ?
31 Did you have one episode of sudden intense back pain that leaves you unable to move ?
32 Have you taken anti-inflammation drugs or pain-killers ?
HIP
33 Do you have pain on crossing your legs ?
34 Do you have any pain when opening your legs to the maximum ?
35 Do you often have pain from your buttocks along the length of the leg down to your ankles ?
36 Have you taken a single dose of anti-inflammatory drugs or pain-killers ?
KNEE
37 Do you have pain in the knee in the act of sitting down or getting up ?
38 Do you have pain in your knee after having walked a lot ?
39 Is your knee often swollen at the end of the day ?
40 Do you have pain in the "good" knee ?
41 Do you have pain or a bothersome feeling as you a kneel down ?
42 When lying in bed, do you feel the need to move your legs, ones or more than once ?
43 Have you taken a single dose of anti-inflammatory drugs or pain-killers ?
FOOT
44 Do you often feel a sensation of pins and needles that runs down to one or more toes ?
45 Do you have any difficulty in standing on your toes ?
46 Do you have any pain in your foot after walking for a long time ?
47 Do you have pain on taking the first step in the morning ?
48 Do you have any difficulty or pain when putting on stiff orthopedic shoes ?
49 Do you have pain under the heel when walking a lot ?
50 Have you taken a single dose of anti-inflammatory drugs or pain-killers ?
Supplemental Table 2. Volume of PA, physical fitness, HbA1c and other modifiable CVD risk factors at baseline and end-of-study period in the EXE and
CON subjects.
CON
CON
P value
EXE
EXE
P value
Mean difference
P value
Baseline
12 months
0-12 months
Baseline
12 months
0-12 months
(95% CI)
EXE vs. CON
LTPA, METs . h-1 . wk-1
0.5812
9.478.1
<0.0001
0.812.0
19.897.9
<0.0001
10.2 (7.5; 12.9)
<0.0001
VO2max, ml/Kg/min
24.66.6
26.16.4
<0.0001
24.55.0
29.95.6
<0.0001
4.1 (3.0; 5.2)
<0.0001
Upper body strength, Kg
36.518.8
37.118.9
0.91
42.820.1
55.423.4
<0.0001
11.9 (9.0; 14.9)
<0.0001
Lower body strength, Kg
63.946.4
64.846.5
0.32
72.751.3
97.059.1
<0.0001
23..3 (16.5; 29.8)
<0.0001
Bending, cm
12.610.2
12.010.8
0.48
15.111.0
8.19.2
<0.0001
-6.4 (-4.1; -8.8)
<0.0001
HbA1c, % (mmol/mol)
7.011.4
6.681.2
0.006
7.091.4
6.451.0
<0.0001
-0.31 (-0.7; -0.04)
0.03
(5315.3)
(4913.1)
(5415.3)
(4710.9)
Fasting glucose, mg/dl
8.553.00
7.832.61
0.08
8.553.27
7.551.89
<0.008
-0.26 (-1.30; 0.78)
0.50
Serum insulin, µU/ml
82.747.9
97.948.6
0.03
73.644.5
87.554.9
0.02
-0.42(-15.3; 14.6)
0.05
4.43.2
4.82.6
0.26
4.33.8
4.22.8
0.88
-0.46 (-1.5; 0.6)
0.39
104.112.0
103.411.0
0.20
104.012.6
99.911.9
<0.0001
-3.3 (-5.2; -1.4)
<0.0001
BMI, Kg/m2
31.64.9
31.24.6
0.10
31.34.9
30.54.9
<0.0001
-0.44 (-1.0; 0.14)
0.14
Systolic BP, mmHg
14416.9
142.516.3
0.49
140.517.0
132.411.5
<0.001
-6.53 (-12.9; -0.12)
0.05
Diastolic BP, mmHg
86.58.1
85.37.8
0.29
83.48.8
79.88.0
<0.009
-2.5 (-5.8; 0.9)
0.21
Triglycerides, mg/dl
1.591.13
1.701.02
0.30
1.491.32
1.450.67
0.74
-0.15 (-0.49; 0.19)
0.39
Total cholesterol, mg/dl
5.150.85
5.230.88
0.43
5.130.98
4.790.88
0.005
-0.45 (-0.78;-0.11)
0.01
HOMA-IR, index
Waist circumference, cm
(-3.4 [-7.7; -0.4])
HDL cholesterol, mg/dl
1.200.29
1.210.26
0.55
1.160.25
1.300.27
<0.0001
0.13 (0.07; 0.19)
<0.0001
LDL cholesterol, mg/dl
3.260.83
3.260.80
0.99
3.340.98
2.820.73
<0.0001
-0.52 (-0.84;-0.19)
0.002
2.90.2
2.60.2
0.35
3.20.2
2.10.2
0.0001
-0.8 (-1.5; -0.1)
0.03
hs-CRP, mg/l
Values are mean±SD; PA = physical activity; CVD = cardiovascular disease; CON = control group; EXE = exercise group; LTPA = leisure-time PA; METs =
metabolic equivalents; VO2max = maximal oxygen consumption; HOMA-IR = Homeostasis Model Assessment-Insulin Resistance; BP = blood pressure; hsCRP = high sensitivity-C-reactive protein.