Chapter 3
Design of a randomized-controlled trial on
low-intensity aerobic wheelchair exercise for
inactive persons with chronic spinal cord injury
Jan W. van der Scheer
Sonja de Groot
Klaas Postema
DirkJan (H.E.J.) Veeger
Lucas H.V. van der Woude
Disabil Rehabil 2013; 35: 1119-1126
3
Chapter 3
wheelchair users (aged 28-65y) with chronic paraplegia or tetraplegia (time since
-
40
Design of the RCT
1
2
3
1
As a
9
9
10
12
13
prescribing moderate to vigorous aerobic intensities
15
Table 1.
College of Sports Medicine.16
Measure of intensity
Relative intensity
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17-19
17
41
3
1
Chapter 3
19
16
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22
23
Although
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25
Figure 1.
Wheelchair skill performance and physical activity levels
a
42
Design of the RCT
26
27
-
29
2
Another mechanism leading to improved propulsion technique during low-inten-
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31
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»
»
levels);
» lead to an optimized propulsion technique; and
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3
1
Chapter 3
Participants
-
Table 2.
Inclusion criteria
Aged 28-65 years
Exclusion criteria
Cardiovascular contra-indications for testing according to the ACSM guidelines33
cate performance of wheelchair propulsion
34
44
Design of the RCT
Design
All exercise tests and training sessions will be conducted within the two rehabili-
Measurement
Week
T1
T2
T3
T4
0
8
16
42
Exercise group
Control group
Low-intensity
wheelchair training
No intervention provided
No intervention provided
Figure 2.
Randomization
-
Table 3. Group size and allocation ratio of the two rehabilitation centers.
RC 1
RC 2
3:2
1:2
5 or 10
3 or 6
N
25
15
N
15
5
N
10
10
45
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1
Chapter 3
Table 4.
Exercise
(min)
Exercise + rest
(min)
Exercise blocks
(N)
Rest between
exercise blocks
(min)
18
23
6
1
18
28
6
2
18
28
6
2
24
29
6
1
24
34
6
2
24
38
8
2
30
31-35
2-6
1
30
33-40
4-6
1-1.5
30
39-48
10
1-1.5
30
30
1
0
30
33
4
1
30
39
10
1
Week 1
Week 2
Week 3-7
Week 8-16
A 16-week low-intensity aerobic wheelchair exercise program will be employed; participants conduct two 30-minute sessions per week on a motor-driven treadmill (center
In some persons
37
38
21
-1
46
and can be lower depending
Design of the RCT
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3
1
-
38
Outcomes
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-
47
48
Lesion level
Demographics
and
environmental
Supplementary outcomes
Wheelchair skill performance
Shoulder load
Upper-body discomfort
Upper-body pain
Secondary outcomes
44
ASIA assessment
Mechanical wheelchair odometer48
Wheelchair Circuit
35
46
42
Questionnaire on musculoskeletal upper-body pain8
45
28,47
34
X
X
X
X
Xb
Xb
X
X
X
X
Xb
Xb
X
X
X
X
X
X
X
X
a
X
X
X
X
X
X
X
T3
a
X
X
X
X
Isometric wheelchair push
X
X
Isometric strength
43
15m overground wheelchair sprint
X
X
Anaerobic work capacity
X
X
35
35
X
X
35
35
T2
T1
Instrumentation
Outcome measure
Table 5.
Xb
Xb
X
X
X
X
X
X
X
X
X
X
T4
Chapter 3
satisfaction
c
b
a
and
sitting
53
21
Forced spirometry measurements
49
51
57
54
2
5
50
55
56
Xb
X
c
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Systematic assessment, by researcher and paramedic research assistant, whether there are changes relative to the T1 measurement.
Not performed in order to reduce participant burden.
Independence
Quality of life
Mood
Fatigue
Metabolic health
Wheelchair
comfort
Goniometer-measured angles of shoulder, elbow and wrist joints
X
X
X
X
X
X
X
X
X
Xb
X
X
X
X
X
X
X
X
X
Xb
Design of the RCT
3
1
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Chapter 3
Peak and submaximal wheelchair exercise test
35
-
-1
58
35
15m overground wheelchair sprint
Anaerobic work capacity will be based on PO during a 15m overground wheelchair
35
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Isometric wheelchair push
It can be seen as an isometric wheelchair push with
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50
Design of the RCT
3
1
Figure 3. Set-up of the isometric wheelchair push used to assess isometric strength. See chapter
5 for a schematic presentation of the set-up.
Self-report questionnaires on upper-body pain
8
60
shown
-
Local Perceived Discomfort (LPD) scale
similar to a protocol used to study handcycling in able-bodied
61
61
It
51
Chapter 3
Propulsion technique
28
2
Delft Shoulder and Elbow model
12
12
Wheelchair Circuit
35
Physical Activity Scale for Individuals With Physical Disabilities (PASIPD)
Wheelchair odometer
Statistical analysis
and was based on two intervention studies: low-intensity aerobic
wheelchair exercise in able-bodied persons and handcycle exercise in persons with tet62
52
Design of the RCT
3
1
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Chapter 3
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Design of the RCT
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Chapter 3
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Design of the RCT
3
1
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