648
H. Ihle-Hansen et al.
in Table II. The results from complete case analyses
showed the same trends (data not shown).
Unadjusted regression analysis applied to the inter-
vention arm showed a significant association between
increasing adherence to the intervention and improve-
ment on TMT A, TMT B and MMSE. However, only
MMSE remained significant in the adjusted analysis
(B = 0.030 (95% CI 0.005–0.055, p = 0.020) (Table III).
Table I. Baseline characteristics (n = 362)
Assessment
Demographics
Female, n (%)
Age, years, mean (SD)
Stroke subtype, n (%)
Cerebral infarction
Cerebral haemorrhage
Risk factors, n (%)
Hypertension
Previous stroke/TIA
Diabetes
Coronary heart disease
Atrial fibrillation
Lung disease
Assessments
NIHSS, mean (SD)
NIHSS < 8, n (%)
NIHSS 8–16, n (%)
NIHSS > 16, n (%)
mRS, mean (SD)
mRS 0–2, n (%)
mRS 3–4, n (%)
Intervention (n = 177) Control (n = 185)
78 (44.1)
71.4 (11.3) 65 (35.1)
72.0 (11.3)
163 (92.1)
14 (7.9) 166 (89.7)
19 (10.3)
85
26
24
18
28
18 104 (56.2)
35 (18.9)/16 (8.6)
27 (14.6)
24 (13.0)
41 (22.2)
23 (12.4)
(48.0)
(14.7)/20 (11.3)
(13.6)
(10.2)
(15.8)
(10.2)
1.47 (2.2)
172 (97.2)
5 (2.8)
0 (0)
1.44 (1.1)
141 (79.7)
36 (20.3)
DISCUSSION
1.70 (2.5)
179 (96.8)
6 (3.2)
0 (0)
1.44 (1.1)
146 (78.9)
39 (21.1)
Coronary heart disease: previous myocardial infarction or present angina
pectoris and heart failure; atrial fibrillation: permanent or paroxysmal atrial
fibrillation; NIHSS: National Institute of Health Stroke Scale; IQR: interquartile
range; mRS: modified Rankin Scale; TIA: transient ischaemic attack; SD:
standard deviation.
186 patient were randomised to intervention and 194
to standard care (9). After exclusion of 18 patients
who died during follow-up (9 from the control group
and 9 from the intervention group), 362 patients were
included in these ITT analyses; 185 were assigned to
control and 177 to intervention. Mean age was 71.7
years (SD 11.3), 39.5% were female and 329 (90.9%)
had had ischaemic stroke. The baseline characteristics
are shown in Table I.
Measures of cognitive function and emotional symp-
toms showed a slight decline in both groups during
follow-up (Table II). The adjusted mean difference
between groups for TMT A was 8.54 (95% CI 0.7 to
16.3), p = 0.032, for TMT B 8.6 (95% CI –16.5 to 33.6),
p = 0.50, for MMSE –0.1 (95% CI –0.8 to 0.6), p = 0.77,
for HADS A –0.2 (95% CI –0.9 to 0.5), p = 0.456 and
for HADS D –0.1 (95% CI –0.7 to 0.5), p = 0.76). The
results based on multiple imputations are presented
This study investigated the effectiveness of an indi-
vidualized physical activity and exercise intervention
programme on cognitive and emotional function post-
stroke compared with usual care. The intervention
involved regular coaching to perform 30 min physical
activity daily every day and 45–60 min of physical ex-
ercise with 2–3 bouts of vigorous intensity levels every
week. No clinically relevant effect of this programme
was found on cognitive or emotional functioning after
18 months compared with usual care. However, regres-
sion analysis applied to the treatment arm only showed
a positive association between increasing adherence to
the intervention and cognitive function.
To our knowledge, this is the first RCT to investigate
the effect of a long-term physical activity programme
on cognitive and emotional function post-stroke in a
rather large cohort with high mean age. The lack of
clinical impact on cognitive measures is in line with
the neutral results shown by the primary and secondary
functional measures (9). There was no effect on emo-
tional function, which is in contrast to a recent study
published by Graven et al. (18), who also included
life-management, barriers and social network. How
ever, our explorative analysis showed an association
between good adherence to the intervention and better
cognitive function, in line with the findings from the
meta-analysis (7).
Since motor recovery after stroke tends to reach a
plateau phase after 10 weeks (19), the initial improve-
Table II. Results of the intervention. Analyses based on multiple imputation of missing values
Intervention group (n=177) Control group (n=185) Between-group differences, change
from baseline to 18 months*
Outcome Baseline
Mean (SE) [n] 18 months
Mean (SE) [n] Baseline
Mean (SE) [n] 18 months
Mean (SE) [n] Estimate
(95% CI)
p-value
TMT A
TMT B
MMSE
HADS A
HADS D 60.5 (2.9) [156]
149.4 (7.4) [132]
27.9 (0.2) [176]
3.6 (0.3) [177]
2.9 (0.2) [177] 70.1 (4.2) [133]
155.8 (9.7) [108]
27.5 (0.3) [143]
3.6 (0.3) [149]
3.7 (0.2) [149] 64.4 (2.6) [169]
169.8 (7.9) [142]
28.0 (0.2) [182]
3.7 (0.3) [180]
3.5 (0.2) [180] 66.0 (3.3) [139]
161.3 (12.0) [101]
27.5 (0.3) [156]
3.8 (0.3) [157]
3.9 (0.3) [157] 8.54 (0.74 to 16.3)
8.6 (–16.5 to 33.6)
–0.1 (–0.8 to 0.6)
–0.2 (–0.9 to 0.5)
–0.1 (–0.7 to 0.5)
0.032
0.50
0.77
0.56
0.76
*Regression coefficient for treatment group in regression analysis, adjusted for age, sex, stroke severity (modified Rankin scale at inclusion), hospital site and
the baseline measure of the relevant variable (TMT A, TMT B, MMS, HADS A or HADS B).
SE: standard error; CI: confidence interval; MMSE: Mini Mental State Examination; TMT A: Trail Making Test A; TMT B: Trail Making Test B; HADS: Hospital Anxiety
and Depression Scale; HADS A: HADS Anxiety; HADS D: HADS Depression.
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