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A randomized controlled trial of an exercise maintenance intervention in men and women post-cardiac rehabilitation (ECO-PCR)
Reid RD, Wooding EA, Blanchard CM, Moghei M, Harris J, Proulx GA, Prince SA, Mullen KA, Ghisi GM, Krahn M, Chessex C, Pipe AL, Mark AE, Grace SL
The Canadian Journal of Cardiology 2021 May;37(5):794-802
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Exercise maintenance interventions are needed for cardiac rehabilitation (CR) graduates to maintain moderate and vigorous-intensity physical activity (MVPA). We tested an exercise facilitator intervention (EFI) to promote exercise maintenance compared to usual care (UC) separately in men and women. METHODS: This was a 3-site, randomized (1:1), parallel-group, superiority trial (ECO-PCR). CR graduates were stratified by site and sex, and randomly allocated (concealed). EFI participants received a face-to-face introductory session, 5 small-group counseling teleconferences, and 3 personal calls from a trained facilitator over 50 weeks. In-person assessments were undertaken at baseline, 26 and 52 weeks after randomization. The primary outcome was weekly minutes of MVPA, measured by accelerometer. Secondary outcomes were exercise capacity, risk factors, quality of life and enrolment in community-based exercise programs. Effects were tested using linear mixed models. RESULTS: 449 graduates (135 women, 314 men) were randomized (n = 226 EFI, n = 223 UC). In the intent-to-treat analysis for men and for women, there were no significant effects for treatment or time on MVPA. In a planned secondary analysis that considered only those adherent to EFI (completed >= 66% of sessions; per-protocol), bouted MVPA was higher in women in the EFI group (mean 132.6 +/- 135.2 minutes/week at 52 weeks) compared to UC (111.8 +/- 113.1; p = 0.013). With regard to secondary outcomes, in women, a treatment group main-effect was observed for blood pressure (p = 0.011) and exercise capacity (p = 0.019; both per-protocol) favoring EFI; no other differences were observed. CONCLUSIONS: In this trial of CR completers, an EFI showed promise for women, but was ineffective in men.

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