Background
Methods
Interventions
Randomised trial intervention protocol | BreathingSpace community rehabilitation programme | |
---|---|---|
Duration of programme | Twice weekly 2 hour classes for 6 weeks (total 12 hours) | Twice weekly 90 minute classes for 8 weeks (total 12 hours) |
Delivery of programme | Delivered by physiotherapist and support worker, assessments performed by research team | Delivered by trained support workers supervised by physiotherapist or occupational therapist |
Content of programme | 1 hour of review, warm-up, exercise and cool-down; 1 hour for education; participants being encouraged to exercise between formal classes. Exercise diary kept between sessions and individualised exercise booklet provided at the end of the course. | 1 hour of warm-up, exercise and cool-down; 30 minutes for education; participants being encouraged to exercise and keep an exercise diary between formal classes. |
Inclusion/exclusion criteria | Diagnosis of COPD by respiratory physician, using GOLD guidelines | Diagnosed respiratory condition confirmed with spirometry; |
Medical Research Council (MRC) grade 3 or worse dyspnoea despite optimal medical care | Experiencing breathlessness in day to day life despite optimal respiratory medication | |
Clinically stable at least 4 weeks before commencing rehabilitation. | No cardiac event in the past 3 months and any known cardiac condition well controlled and stable. |
Data collection and analysis
Results
Recruitment and retention
Randomised trial – community setting intervention group | BreathingSpace – all participants | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
n | Mean | SD | Min | Max | n | Mean | SD | Min | Max | P-value for difference between groups | |
Age (years) | 111 | 68.7 | 8.3 | 49 | 86 | 451 | 69.7 | 8.9 | 45 | 92 | 0.3 |
Body mass index (kg/m2) | 111 | 25.4 | 5.6 | 14.0 | 44.0 | 421 | 27.5 | 6.5 | 12.5 | 66.2 | 0.001* |
FEV1 (litres) | 111 | 1.1 | 0.4 | 0.3 | 2.6 | 416 | 1.2 | 0.5 | 0.3 | 3.0 | 0.03* |
Actual FEV1 as a proportion of predicted FEV1 (%) | 111 | 45.1 | 16.3 | 16.8 | 89.8 | 417 | 48.3 | 16.6 | 15.0 | 117.0 | 0.07 |
FVC (litres) | 111 | 2.7 | 0.9 | 1.2 | 5.3 | 415 | 2.4 | 0.8 | 0.9 | 6.5 | 0.002* |
Actual FVC as a proportion of predicted FVC (%) | 111 | 86.7 | 19.3 | 50.8 | 137.5 | 412 | 79.4 | 18.1 | 28.0 | 136.0 | <0.001* |
Relaxed vital capacity (litres) | 111 | 2.7 | 0.9 | 1.4 | 5.1 | 398 | 2.5 | 0.8 | 0.7 | 6.1 | 0.04* |
FEV1/FVC | 111 | 0.4 | 0.1 | 0.2 | 1.0 | 412 | 0.5 | 0.1 | 0.2 | 0.9 | <0.001* |
n
|
%
|
n
|
%
| ||||||||
Gender
| |||||||||||
Female | 49 | 44 | 219 | 49 | 0.5 | ||||||
Male | 62 | 56 | 231 | 51 | |||||||
Total
|
111
|
100
|
450
|
100
| |||||||
MRC breathlessness grade
| |||||||||||
1 | - | - | 8 | 2 | <0.001* | ||||||
2 | - | - | 68 | 16 | |||||||
3 | 38 | 34 | 169 | 40 | |||||||
4 | 37 | 33 | 132 | 32 | |||||||
5 | 36 | 32 | 41 | 10 | |||||||
Total
|
111
|
100
|
418
|
100
|
Randomised trial – community setting intervention group | BreathingSpace – participants MRC ≥3 | ||||||
---|---|---|---|---|---|---|---|
n | Mean | SD | n | Mean | SD | P-value for difference in means | |
CRQ symptoms
| |||||||
Dyspnoea | 75 | 3.2 | 0.9 | 329 | 2.9 | 1.0 | 0.002* |
Fatigue | 75 | 3.3 | 1.2 | 329 | 3.4 | 1.3 | 0.73 |
Emotion | 75 | 4.4 | 1.3 | 329 | 4.4 | 1.4 | 0.92 |
Mastery | 75 | 4.3 | 1.4 | 329 | 4.5 | 1.4 | 0.40 |
SF-36v2 domains
| |||||||
Physical functioning | 75 | 32.0 | 20.3 | 335 | 31.8 | 23.4 | 0.95 |
Role-physical | 76 | 36.6 | 22.0 | 333 | 36.7 | 27.4 | 0.98 |
Bodily pain | 74 | 58.2 | 27.9 | 313 | 54.4 | 29.7 | 0.30 |
General health | 74 | 35.6 | 18.7 | 304 | 33.1 | 19.5 | 0.30 |
Vitality | 75 | 38.7 | 18.6 | 306 | 37.7 | 21.2 | 0.68 |
Social functioning | 76 | 49.7 | 30.8 | 313 | 52.6 | 33.0 | 0.47 |
Role-emotional | 76 | 58.1 | 29.8 | 304 | 56.3 | 34.0 | 0.65 |
Mental health | 76 | 65.1 | 21.5 | 310 | 66.4 | 20.5 | 0.63 |
PCS (Physical component summary) | 71 | 32.2 | 7.4 | 291 | 31.2 | 9.7 | 0.32 |
MCS (Mental component summary) | 71 | 42.3 | 12.2 | 291 | 43.7 | 13.1 | 0.38 |
SF-6D
| 71 | 0.61 | 0.11 | 291 | 0.59 | 0.12 | 0.10 |
EQ-5D-3 L
| 76 | 0.56 | 0.27 | 291 | 0.50 | 0.21 | 0.09 |
Randomised trial – community setting intervention group | BreathingSpace – all participants | ||||||
---|---|---|---|---|---|---|---|
n | Mean | SD | n | Mean | SD | P-value for difference in means | |
CRQ symptoms
| |||||||
Dyspnoea | 75 | 3.2 | 0.9 | 481 | 2.9 | 1.1 | 0.02* |
Fatigue | 75 | 3.3 | 1.2 | 481 | 3.5 | 1.3 | 0.2 |
Emotion | 75 | 4.4 | 1.3 | 481 | 4.5 | 1.3 | 0.6 |
Mastery | 75 | 4.3 | 1.4 | 481 | 4.5 | 1.4 | 0.2 |
SF-36v2 domains
| |||||||
Physical functioning | 75 | 32.0 | 20.3 | 443 | 32.0 | 23.2 | 1.0 |
Role-physical | 76 | 36.6 | 22.0 | 442 | 36.7 | 26.7 | 1.0 |
Bodily pain | 74 | 58.2 | 27.9 | 413 | 53.6 | 29.2 | 0.2 |
General health | 74 | 35.6 | 18.7 | 401 | 33.4 | 20.0 | 0.4 |
Vitality | 75 | 38.7 | 18.6 | 404 | 37.9 | 20.8 | 0.7 |
Social functioning | 76 | 49.7 | 30.8 | 413 | 53.1 | 32.7 | 0.4 |
Role-emotional | 76 | 58.1 | 29.8 | 404 | 55.6 | 34.1 | 0.5 |
Mental health | 76 | 65.1 | 21.5 | 408 | 66.4 | 20.5 | 0.6 |
PCS (Physical component summary) | 71 | 32.2 | 7.4 | 385 | 31.0 | 9.7 | 0.3 |
MCS (Mental component summary) | 71 | 42.3 | 12.2 | 385 | 43.7 | 13.1 | 0.4 |
SF-6D
| 71 | 0.61 | 0.11 | 381 | 0.60 | 0.12 | 0.6 |
EQ-5D-3 L
| 76 | 0.56 | 0.27 | 385 | 0.53 | 0.23 | 0.4 |
Randomised trial – community setting intervention group | BreathingSpace – participants MRC > =3Mean after-before difference | |||||||
---|---|---|---|---|---|---|---|---|
n | Mean before-after difference | SD | n | Mean before-after difference | SD | Difference in mean before-after differences (95% CI) | P-value for difference in mean before-after differences | |
CRQ symptoms
| ||||||||
Dyspnoea
|
74
|
0.29
|
1.18
|
329
|
0.55
|
1.20
|
0.26 (−0.04, 0.56)
|
0.09
|
Fatigue
|
75
|
0.58
|
1.12
|
329
|
0.51
|
1.21
|
−0.07 (−0.36, 0.21)
|
0.61
|
Emotion
|
74
|
0.39
|
0.98
|
329
|
0.34
|
1.15
|
−0.05 (−0.31, 0.21)
|
0.70
|
Mastery
|
75
|
0.36
|
1.08
|
329
|
0.27
|
1.24
|
−0.09 (−0.37, 0.19)
|
0.53
|
SF-36v2 domains
| ||||||||
Physical functioning
|
79
|
0.87
|
17.6
|
333
|
5.81
|
20.4
|
4.94 (0.36, 9.53)
|
0.03*
|
Role-physical
|
79
|
8.25
|
24.6
|
331
|
7.30
|
27.0
|
−0.95 (−7.27, 5.36)
|
0.77
|
Bodily pain
|
78
|
1.29
|
25.8
|
277
|
2.93
|
26.3
|
1.64 (−5.07, 8.35)
|
0.63
|
General health
|
77
|
3.93
|
15.7
|
263
|
3.17
|
17.0
|
−0.76 (−4.94, 3.42)
|
0.72
|
Vitality
|
79
|
8.15
|
16.8
|
269
|
7.59
|
21.4
|
−0.55 (−5.18, 4.08)
|
0.81
|
Social functioning
|
80
|
12.7
|
29.5
|
277
|
8.35
|
32.7
|
−4.31 (−12.04, 3.42)
|
0.27
|
Role-emotional
|
79
|
5.17
|
31.0
|
268
|
7.91
|
34.8
|
2.74 (−5.44, 10.93)
|
0.51
|
Mental health
|
80
|
5.81
|
15.7
|
274
|
4.76
|
19.5
|
−1.05 (−5.31, 3.20)
|
0.62
|
PCS (Physical component summary)
|
73
|
0.98
|
6.49
|
249
|
1.31
|
7.76
|
0.33 (−1.48, 2.13)
|
0.72
|
MCS (Mental component summary)
|
73
|
5.38
|
10.4
|
249
|
3.95
|
12.8
|
−1.43 (−4.35, 1.49)
|
0.34
|
SF-6D
|
72
|
0.014
|
0.10
|
245
|
0.030
|
0.11
|
0.016 (−0.010, 0.043)
|
0.23
|
EQ-5D-3 L
|
80
|
0.066
|
0.28
|
249
|
0.044
|
0.15
|
−0.022 (−0.086, 0.042)
|
0.51
|
Randomised trial – community setting intervention group | BreathingSpace – all participants | |||||||
---|---|---|---|---|---|---|---|---|
n | Mean before-after difference | SD | n | Mean before-after difference | SD | Difference in mean before-after differences (95% CI) | P-value for difference in mean before-after differences | |
CRQ symptoms
| ||||||||
Dyspnoea
|
74
|
0.29
|
1.18
|
481
|
0.61
|
1.25
|
0.32 (0.03, 0.62)
|
0.03*
|
Fatigue
|
75
|
0.58
|
1.12
|
481
|
0.48
|
1.22
|
−0.10 (−0.38, 0.18)
|
0.31
|
Emotion
|
74
|
0.39
|
0.98
|
481
|
0.36
|
1.15
|
−0.03 (−0.27, 0.22)
|
0.79
|
Mastery
|
75
|
0.36
|
1.08
|
481
|
0.32
|
1.20
|
−0.04 (−0.31, 0.23)
|
0.86
|
SF-36v2 domains
| ||||||||
Physical functioning
|
79
|
0.87
|
17.6
|
438
|
5.47
|
20.1
|
4.61 (0.16, 9.06)
|
0.08
|
Role-physical
|
79
|
8.25
|
24.6
|
437
|
7.36
|
26.6
|
−0.9 (−7.04, 5.24)
|
0.57
|
Bodily pain
|
78
|
1.29
|
25.8
|
356
|
2.55
|
26.3
|
1.25 (−5.30, 7.80)
|
0.71
|
General health
|
77
|
3.93
|
15.7
|
337
|
3.29
|
16.5
|
−0.64 (−4.68, 3.40)
|
0.78
|
Vitality
|
79
|
8.15
|
16.8
|
345
|
6.75
|
20.5
|
−1.4 (−5.82, 3.03)
|
0.42
|
Social functioning
|
80
|
12.7
|
29.5
|
356
|
7.97
|
31.7
|
−4.69 (−12.16, 2.79)
|
0.11
|
Role-emotional
|
79
|
5.17
|
31.0
|
346
|
7.77
|
32.9
|
2.6 (−5.26, 10.46)
|
0.38
|
Mental health
|
80
|
5.81
|
15.7
|
351
|
4.65
|
18.7
|
−1.16 (−5.23, 2.92)
|
0.48
|
PCS (Physical component summary)
|
73
|
0.98
|
6.49
|
317
|
1.11
|
7.5
|
0.13 (−1.61, 1.87)
|
0.84
|
MCS (Mental component summary)
|
73
|
5.38
|
10.4
|
317
|
3.78
|
12.1
|
−1.59 (−4.39, 1.20)
|
0.24
|
SF-6D
|
72
|
0.014
|
0.10
|
308
|
0.029
|
0.11
|
0.015 (−0.011, 0.040)
|
0.30
|
EQ-5D-3 L
|
80
|
0.066
|
0.28
|
317
|
0.039
|
0.14
|
−0.027 (−0.090, 0.036)
|
0.42
|