Mayo Clinic proceedings · 2015
Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial.
СтатьяPragmatic Clinical TrialРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Grace Sherry L, Midence Liz, Oh Paul, Brister Stephanie, Chessex Caroline, Stewart Donna E, Arthur Heather M
Аннотация
OBJECTIVE: To compare program adherence and functional capacity between women referred to supervised mixed-sex, supervised women-only, or home-based cardiac rehabilitation (CR).
PATIENTS AND METHODS: Cardiac Rehabilitation for Heart Event Recovery (CR4HER) was a single-blind, 3 parallel-arm, pragmatic randomized controlled trial. The study took place between November 1, 2009, and July 31, 2013. Low-risk patients with coronary artery disease were recruited from 6 hospitals in Ontario, Canada. Consenting participants completed a preprogram survey, and clinical data were extracted from charts. Participants were referred to CR at 1 of 3 sites. After intake assessment, including a graded exercise stress test, eligible patients were randomized to supervised mixed-sex, supervised women-only, or home-based CR. Six months later, CR adherence and exit assessment data were ascertained.
RESULTS: Of the 264 consenting patients, 169 (64.0%) were eligible and randomized. Twenty-seven (16.0%) did not attend, and 43 (25.4%) attended a different model. Program adherence was moderate overall (54.46%±35.14%). Analysis of variance revealed no significant differences based on per-protocol analysis (P=.63), but as-treated, home-based participants attended significantly more than did women-only participants (P<.05). Overall, there was a significant increase in functional capacity preprogram to postprogram (P<.001). Although there were no significant differences in functional capacity by model at CR exit based on per-protocol analysis, there was a significant difference on an as-treated basis, which sustained adjustment. Women attending mixed-sex CR attained significantly higher post-CR functional capacity than did women attending home-based programs (P<.05).
CONCLUSION: Offering women alternative program models may not promote greater CR adherence or functional capacity; however, replication is warranted. Other proven strategies such as action planning and self-monitoring should be applied.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01019135.
PATIENTS AND METHODS: Cardiac Rehabilitation for Heart Event Recovery (CR4HER) was a single-blind, 3 parallel-arm, pragmatic randomized controlled trial. The study took place between November 1, 2009, and July 31, 2013. Low-risk patients with coronary artery disease were recruited from 6 hospitals in Ontario, Canada. Consenting participants completed a preprogram survey, and clinical data were extracted from charts. Participants were referred to CR at 1 of 3 sites. After intake assessment, including a graded exercise stress test, eligible patients were randomized to supervised mixed-sex, supervised women-only, or home-based CR. Six months later, CR adherence and exit assessment data were ascertained.
RESULTS: Of the 264 consenting patients, 169 (64.0%) were eligible and randomized. Twenty-seven (16.0%) did not attend, and 43 (25.4%) attended a different model. Program adherence was moderate overall (54.46%±35.14%). Analysis of variance revealed no significant differences based on per-protocol analysis (P=.63), but as-treated, home-based participants attended significantly more than did women-only participants (P<.05). Overall, there was a significant increase in functional capacity preprogram to postprogram (P<.001). Although there were no significant differences in functional capacity by model at CR exit based on per-protocol analysis, there was a significant difference on an as-treated basis, which sustained adjustment. Women attending mixed-sex CR attained significantly higher post-CR functional capacity than did women attending home-based programs (P<.05).
CONCLUSION: Offering women alternative program models may not promote greater CR adherence or functional capacity; however, replication is warranted. Other proven strategies such as action planning and self-monitoring should be applied.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01019135.