Table 2.
Crude change in outcomes from baseline at the different assessment points and estimated adjusted treatment effects with 95% CIs (on intention-to-treat basis)
| Number of participants | Crude change from baseline* or % endorsing favourable outcome† | Estimated treatment effect (group difference in mean change‡ or risk ratio§) with 95% CI | P value¶ | |||
| Control | TERECO | Control | TERECO | |||
| Primary outcome | ||||||
| 6MWD (m) | ||||||
| Post-treatment (6 weeks) | 60 | 52 | 17.09±63.94 | 80.20±74.66 | 65.45 (43.80 to 87.10) | <0.001 |
| Follow-up (~28 weeks) | 55 | 50 | 15.17±70.02 | 84.81±80.38 | 68.62 (46.39 to 90.85) | <0.001 |
| Secondary outcomes | ||||||
| Squat time (s) | ||||||
| Post-treatment (6 weeks) | 60 | 52 | 7.98±19.53 | 29.35±27.22 | 20.12 (12.34 to 27.90) | <0.001 |
| Follow-up (~28 weeks) | 55 | 50 | 4.16±19.62 | 28.12±27.17 | 22.23 (14.24 to 30.21) | <0.001 |
| Pulmonary function | ||||||
| FEV1 (L) | ||||||
| Post-treatment (6 weeks) | 56 | 51 | 0.18±0.53 | 0.28±0.51 | 0.08 (−0.08 to 0.25) | 0.327 |
| Follow-up (~28 weeks) | 53 | 47 | 0.29±0.43 | 0.29±0.48 | 0.00 (−0.18 to 0.17) | 0.969 |
| FVC (L) | ||||||
| Post-treatment (6 weeks) | 56 | 51 | 0.19±0.40 | 0.21±0.47 | 0.02 (−0.14 to 0.18) | 0.818 |
| Follow-up (~28 weeks) | 53 | 47 | 0.27±0.43 | 0.30±0.38 | 0.01 (−0.16 to 0.17) | 0.95 |
| FEV1/FVC | ||||||
| Post-treatment (6 weeks) | 56 | 51 | 0.01±0.16 | 0.04±0.17 | 0.03 (−0.02 to 0.07) | 0.224 |
| Follow-up (~28 weeks) | 53 | 47 | 0.02±0.15 | 0.02±0.18 | −0.01 (−0.05 to 0.03) | 0.732 |
| MVV (L/min) | ||||||
| Post-treatment (6 weeks) | 56 | 51 | 5.61±17.31 | 14.49±21.60 | 10.57 (3.26 to 17.88) | 0.005 |
| Follow-up (~28 weeks) | 53 | 47 | 13.81±20.78 | 18.47±22.31 | 5.20 (−2.33 to 12.73) | 0.176 |
| PEF (L/s) | ||||||
| Post-treatment (6 weeks) | 56 | 51 | 0.66±1.95 | 0.98±1.90 | 0.38 (−0.24 to 1.00) | 0.229 |
| Follow-up (~28 weeks) | 53 | 47 | 0.97±1.84 | 0.76±1.92 | −0.02 (−0.66 to 0.62) | 0.954 |
| Quality of life | ||||||
| SF-12 PCS | ||||||
| Post-treatment (6 weeks) | 60 | 52 | 3.84±7.60 | 7.81±7.02 | 3.79 (1.24 to 6.35) | 0.004 |
| Follow-up (~28 weeks) | 55 | 50 | 5.20±9.13 | 8.2±10.05 | 2.69 (0.06 to 5.32) | 0.045 |
| SF-12 MCS | ||||||
| Post-treatment (6 weeks) | 60 | 52 | 4.17±8.79 | 6.15±10.78 | 2.18 (−0.54 to 4.90) | 0.116 |
| Follow-up (~28 weeks) | 55 | 50 | 5.51±7.79 | 6.92±10.28 | 1.99 (−0.81 to 4.79) | 0.164 |
| mMRC perceived dyspnoea, to favourable outcome | ||||||
| Interim 2 weeks | 60 | 54 | 45.0 | 57.4 | 1.27 (0.88 to 1.82) | 0.197 |
| Interim 4 weeks | 60 | 54 | 61.7 | 66.7 | 1.08 (0.82 to 1.42) | 0.605 |
| Post-treatment (6 weeks) | 60 | 52 | 61.7 | 90.4 | 1.46 (1.17 to 1.82) | 0.001 |
| Follow-up (~28 weeks) | 55 | 50 | 60.0 | 72.0 | 1.22 (0.92 to 1.61) | 0.162 |
*Crude change from baseline is given as mean change±SD of this change for all outcomes apart from for mMRC (favourable outcome).
†For mMRC, per cent being dyspnoea-free is provided.
‡Estimated treatment effects for all outcomes apart from mMRC-dyspnoea (favourable outcome) are between-group mean differences in change from baseline derived from mixed effects regression with random intercept for study participant; models are constrained to a common baseline mean across groups and adjusted for centre. Estimation includes all available observations from participants randomised (number of participants with valid observations at baseline is 115 for pulmonary function parameters and 119 for all other outcomes).
§Estimated treatment effects for mMRC-dyspnoea (favourable outcome) are risk ratios derived from generalised linear model from Poisson family with log link adjusted for centre and ln(number valid observations up to data point) as offset; 95% CIs are based on cluster robust SEs (cluster variable: participant ID).
¶Probability of treatment effect being zero.
CI, confidence interval; MCS, mental component score; mMRC, modified Medical Research Council; MVV, maximum voluntary ventilation; 6MWD, six min walking distance; PCS, physical component score; PEF, peak expiratory flow; SF-12, Short Form Health Survey-12; TERECO, telerehabilitation intervention for COVID-19 survivors.