Table 3.
Changes in physical measurements and tests from baseline to 3-month follow-up in the NUTRI-HAB trial. Changes from Baseline to 3-month Follow-up.
| Baseline Values | Changes from Baseline to 3-Month Follow-Up | |||||||
|---|---|---|---|---|---|---|---|---|
| Intervention Group | Control Group | Intervention Group | Control Group | Difference between Groups a p-Value |
Effect Size Cohen’s d [95% Confidence Interval] |
Adjusted Model b | ||
| β | p-Value | |||||||
| Primary outcome | ||||||||
| Intention-to-treat analysis | ||||||||
| Body weight (kg) (36/35) c | 78.8 ± 2.3 | 79.3 ± 2.8 | 0.46 ± 0.43 d | 0.38 ± 0.56 d | 0.910 | 0.194 | 0.795 | |
| Per protocol analysis | ||||||||
| Body weight (kg) (29/30) c | 80.4 ± 12.8 | 77.8 ± 16.5 | 0.45 ± 1.66 d | 0.41 ± 3.06 d | 0.958 | 0.01 [−0.50, 0.52] | 0.215 | 0.752 |
| Secondary outcomes | ||||||||
| Physical measurements and tests | ||||||||
| Body mass index (kg/m2) (29/30) c | 26.7 ± 4.4 | 27.0 ± 5.1 | 0.45 ± 1.66 d | 0.41 ± 3.06 d | 0.958 | 0.01 [−0.50, 0.52] | 0.215 | 0.752 |
| Maximal mouth opening (mm) (29/29) c | 47.7 ± 7.1 | 42.8 ± 10.1 | 0.6 ± 1.6 | −0.3 ± 2.1 | 0.088 | 0.46 [−0.07, 0.98] | 0.962 | 0.072 |
| Maximal hand grip strength (kg) (29/30) c | 39.4 ± 9.2 | 39.3 ± 13.0 | 1.3 ± 3.8 | −0.6 ± 3.3 | 0.038 | 0.55 [0.03, 1.07] | 1.950 | 0.042 |
| 30-s chair stand test (number of repetitions) (28/29) c |
15.1 ± 4.2 | 13.8 ± 4.1 | 0.5 ± 2.3 | 2.3 ± 3.1 * | 0.012 | −0.69 [−1.22, −0.15] | −2.074 | 0.008 |
| 6-min walk test (m) (28/28)c | 562.7 ± 72.1 | 572.9 ± 115.7 | 34.6 ± 43.4 *,# | 8.5 ± 57.7 | 0.061 | 0.51 [−0.02, 1.04] | 18.620 | 0.192 |
Baseline values and changes within groups are shown as means ± standard deviations (standard error in intention-to-treat analysis). Significant p-values are highlighted in bold. a Differences between groups are tested with linear regression in intention-to-treat analysis and with a two-sample two-sided t-test in per protocol analyses. b Differences between groups assessed in a multiple linear regression model including gender, time interval (months) posttreatment, and rehabilitation needs assessed by the REHPA scale. c n included in analyses in (intervention/control) groups. d Changes in body weight and body mass index from baseline to 3-month follow-up is shown in percent. * Statistically significant change (p < 0.05) within group from baseline to 3-month follow-up tested with a paired two-sided t-test in per protocol analyses. Results are shown in Appendix B, Table A2. # Clinically relevant change within group from baseline to 3-month follow-up is defined as a difference between mean value at baseline and 3-month follow up of minimum 5% for weight [41], 5 kg for hand grip strength [54], and 14 m for 6-min walk test [55].