| Methods |
RCT. Random assignment to exercise (EX) or non‐exercise (NEX) group. A stratification procedure, in relation to disease severity (EDSS‐score: 3.0‐4.5 and 5.0‐ 6.5), was undertaken before randomisation |
| Participants |
N = 50: EX = 27, NEX = 23
Inclusion criteria: Clinically definite or laboratory supported MS (Poser ,1983), Kurtzke's EDDS‐score between 3.0 and 6.5, age between 18‐65 years
Exclusion criteria: one or more exacerbations in the preceding 3 months, cognitive impairment (MMSE < 23.8), history of cardiovascular, respiratory, orthopaedic, psychiatric or other medical conditions, pregnancy, Treatment with immunosuppressants, interferons, 4‐aminopyridine or experimental drugs in the 6 months before enrolment, rehabilitation therapy in the 3 months before admission
Type MS: Relapsing‐remitting, primary‐ progressive or secondary‐ progressive MS
Disease duration (yr) ± SD (range): EX: 44.6 ± 10.2, NEX: 44.9 ± 10.6
Mean age (yr) ± SD (range): EX: 44.6 ± 10.2, NEX: 44.9 ± 10.6
% female: EX: 63, NEX: 48
Mean EDSS‐score ± SD: 5.5 (3.0‐6.5), NEX: 5.5 (3.5‐7.0) |
| Interventions |
Inpatient physical rehabilitation programme with passive and active interventions.15 weeks; 2x45‐min exercise sessions a day for a period of 3 weeks, versus 12 weeks of a self‐executed exercise programme at home |
| Outcomes |
Kurtzke's EDSS, FIM, SF‐36, HAI and HRSD
Assessment at baseline and after 3, 9 and 15 weeks |
| Notes |
Drop outs: 5‐ patients withdrew from the study before the end of the study period (3 rehabilitation: 1 had a exacerbation, 2 deteriorated clinically; 2 controls: 1 failed to present for the last examination, 1deteriorated), but all were included in the analyses
Details of physical rehabilitation program have been described elsewhere (in Italian). The study is ongoing. The range of EDDS‐scores of the control group exceeds the 6.5 of the inclusion criteria |
