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|Improving activities of daily living ability in women with fibromyalgia: an exploratory, quasi-randomized, phase-two study, IMPROvE trial|
|von Bulow C, Amris K, Bandak E, Danneskiold-Samsoe B, Ejlersen Waehrens E|
|Journal of Rehabilitation Medicine 2017 Mar;49(3):241-250|
|4/10 [Eligibility criteria: Yes; Random allocation: No; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*|
OBJECTIVE: To explore and compare the outcomes of adaptation and physical activity programmes regarding activities of daily living (ADL) ability following interdisciplinary rehabilitation in women with fibromyalgia. METHODS: Participants (n = 85) were quasi-randomized to 16-week adaptation (ADAPT) or physical activity (ACTIVE) programmes following 2-week interdisciplinary rehabilitation. Primary outcomes were ADL motor and ADL process ability, measured with the Assessment of Motor and Process Skills (AMPS) at 4-week follow-up. Data were analysed per protocol. RESULTS: Participants (ADAPT, n = 21; ACTIVE, n = 27) did not differ from withdrawers (n = 37). Improvements in ADL ability in the ADAPT (ADL motor mean change 0.43 logits (95% confidence interval (95% CI) 0.31 to 0.56); ADL process mean change 0.34 logits (95% CI 0.17 to 0.52)) and ACTIVE (ADL motor mean change 0.33 logits (95% CI 0.22 to 0.43); ADL process mean change 0.25 logits (95% CI 0.12 to 0.38)) groups were statistically significant, with no differences between groups. Responder analyses revealed that 63% of all participants obtained clinically relevant improvements in ADL motor ability and 48% in ADL process ability. CONCLUSION: Although limited by a large drop-out, this exploratory study showed that both adaptation and physical activity programmes following interdisciplinary rehabilitation improved ADL ability in the majority of participants. ADL ability outcomes were independent of group allocation (ADAPT versus ACTIVE), suggesting efficacy of both programmes.