Motor complete group | Motor incomplete group | |||||||||
Sham RMT | Active RMT | Sham RMT | Active RMT | |||||||
Baseline (n=20) | 6 weeks (n=19) | Baseline (n=21) | 6 weeks (n=20) | P value | Baseline (n=12) | 6 weeks (n=12) | Baseline (n=9) | 6 weeks (n=9) | P value | |
Primary outcome | ||||||||||
PImax (cmH2O) | 49.9±18.9 | 52.8±19.8 | 42.6±16.5 | 58.3±22.3 | 0.002 | 54.1±21.7 | 58.3±24.0 | 62.1±29.4 | 75.8±24.2 | 0.051 |
Secondary outcomes | ||||||||||
PEmax (cmH2O) | 26.9±10.3 | 28.2±11.4 | 25.0±9.5 | 28.0±10.5 | 0.723 | 43.7±13.4 | 52.1±16.4 | 50.9±21.2 | 61.4±22.9 | 0.509 |
Lung function | ||||||||||
FEV1 (L) | 1.6±0.5 | 1.6±0.6 | 1.5±0.6 | 1.6±0.7 | 0.447 | 2.4±0.7 | 2.4±0.8 | 2.3±0.9 | 2.4±0.9 | 0.648 |
FVC (L) | 2.2±0.8 | 2.1±0.8 | 2.0±0.8 | 2.1±0.9 | 0.412 | 3.2±0.8 | 3.3±0.9 | 3.0±1.0 | 3.2±1.1 | 0.635 |
Inspiratory capacity (L) | 2.0±0.7 | 1.8±0.7 | 1.8±0.7 | 1.9±0.7 | 0.192 | 2.3±0.7 | 2.6±0.8 | 2.3±0.8 | 2.3±0.9 | 0.372 |
PEFc (L/s) | 4.2±1.3 | 4.2±1.4 | 3.9±1.0 | 4.1±1.1 | 0.832 | 5.5±1.8 | 5.6±2.0 | 6.0±1.2 | 6.1±1.6 | 0.915 |
Vital capacity (L) | 2.2±0.8 | 2.3±0.8 | 2.1±0.6 | 2.2±0.9 | 0.157 | 3.4±0.7 | 3.3±0.7 | 3.1±1.0 | 3.3±1.1 | 0.562 |
Total lung capacity (L) | 4.5±1.1 | 4.4±1.3 | 4.9±1.1 | 4.9±1.3 | 0.317 | 5.4±1.4 | 5.6±0.7 | 5.1±1.1 | 5.5±1.1 | 0.994 |
Respiratory complications (n) | 0 | 3 | 0 | 2 | 0.663 | 0 | 3 | 0 | 0 | 0.229 |
Quality of Life: Short Form-36 (SF-36ww)* | ||||||||||
Physical functioning | 43.1±34.8 | 48.5±38.9 | 42.7±32.0 | 59.3±31.1 | 0.204 | N/A | N/A | N/A | N/A | N/A |
Role limitations (physical) | 37.5±43.6 | 63.5±44.0 | 51.9±41.4 | 77.3±39.5 | 0.490 | N/A | N/A | N/A | N/A | N/A |
Role limitations (emotional) | 61.9±46.9 | 71.8±44.8 | 71.8±38.1 | 87.9±22.5 | 0.936 | N/A | N/A | N/A | N/A | N/A |
Energy/fatigue | 50.7±21.3 | 51.9±22.5 | 56.5±18.3 | 63.2±24.0 | 0.736 | N/A | N/A | N/A | N/A | N/A |
Emotional well-being | 74.0±18.5 | 72.9±26.0 | 75.4±18.0 | 73.4±18.9 | 0.694 | N/A | N/A | N/A | N/A | N/A |
Social functioning | 48.3±36.3 | 68.4±30.5 | 70.4±22.5 | 82.0±27.5 | 0.628 | N/A | N/A | N/A | N/A | N/A |
Pain | 59.6±27.4 | 75.5±22.1 | 56.6±23.2 | 62.5±29.5 | 0.659 | N/A | N/A | N/A | N/A | N/A |
General health | 53.9±25.7 | 62.3±28.5 | 54.2±23.5 | 66.4±26.2 | 0.878 | N/A | N/A | N/A | N/A | N/A |
Quality of life: EQ-5D VAS | 59.0±23.7 | 64.2±22.3 | 56.2±17.8 | 69.2±22.6 | 0.099 | 47.9±20.8 | 62.5±20.2 | 64.4±28.4 | 68.3±22.9 | 0.308 |
Perceived breathlessness (Borg score) | ||||||||||
At rest | 0.6±0.8 | 0.5±0.8 | 0.8±1.2 | 1.0±1.6 | 0.190 | 1.0±1.2 | 0.3±0.5 | 0.8±0.9 | 1.1±1.5 | 0.072 |
Loaded inspiratory breaths | 3.7±2.2 | 3.8±2.2 | 2.9±2.4 | 1.8±1.5 | 0.109 | 3.0±1.6 | 2.5±2.0 | 2.9±1.1 | 1.6±1.5 | 0.179 |
Loaded expiratory breaths | 4.6±2.6 | 4.2±1.9 | 3.5±1.9 | 3.0±2.1 | 0.978 | 3.7±2.0 | 3.3±2.1 | 3.0±1.3 | 1.4±1.0 | 0.143 |
St George Respiratory Questionnaire | ||||||||||
Symptom severity score | 20.0±16.8 | 22.9±24.0 | 18.3±24.8 | 20.8±20.8 | 0.190 | 23.7±19.2 | 31.5±23.4 | 21.1±26.3 | 14.7±19.9 | 0.163 |
Activity score | 8.2±10.2 | 5.6±8.2 | 16.8±13.2 | 4.5±1.6 | 0.521 | N/A | N/A | N/A | N/A | N/A |
Impacts score | 19.2±20.0 | 14.4±16.4 | 20.0±16.2 | 7.4±6.4 | 0.730 | N/A | N/A | N/A | N/A | N/A |
Total score | 15.2±13.9 | 13.2±14.4 | 16.6±15.7 | 7.2±6.6 | 0.589 | N/A | N/A | N/A | N/A | N/A |
Data shown as mean±SD.
One-year follow-up data not shown due to small participant numbers in each group.
N/A as data for this outcome was only collected for people with chronic tetraplegia in this group due to the majority of the questions being relevant to people only living at home, resulting in only four participants having complete datasets, insufficient for statistical analysis.
*No data available for the SF-36 in the incomplete group due to only n=5 participants having sustained their injury greater than 1 year prior to enrolment, the complete group has n=14 sham and n=13 active participants.
EQ-5D VAS, EuroQol-Five Dimensional Visual Analogue Scale questionnaire; PEFc, peak expiratory cough flow; PEmax, maximal expiratory pressure; PImax, maximal inspiratory pressure; SF36-ww, Short Form Health Survey: walk/wheel.