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Effects of the original gymnastics for pregnant women program on glycaemic control and delivery outcomes in women with gestational diabetes mellitus: a randomized controlled trial [with consumer summary] |
Jin Y, Chen Z, Li J, Zhang W, Feng S |
International Journal of Nursing Studies 2022 Aug;132:104271 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; 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: Gestational diabetes mellitus affects millions of pregnant women. Lifestyle intervention is recommended as the first-line treatment, in which exercise plays an important role. Effective and safe exercise is required to facilitate glycaemic control and improve delivery outcomes. OBJECTIVE: To investigate the efficacy and safety of the original Gymnastics for Pregnant Women program for glycaemic control and delivery outcomes improvement in gestational diabetes mellitus women. DESIGN: The study was a two-arm parallel randomized controlled clinical trial. SETTING: The study was conducted in a tertiary specialized maternity hospital in Hangzhou, China. PARTICIPANTS: Totally 131 eligible pregnant women were enrolled from June to December 2020. METHODS: Participants were randomly allocated to the control group (conventional intervention) or experimental group that engaged in the original Gymnastics for Pregnant Women program. The primary outcomes included glycaemic control during pregnancy and postpartum. Secondary outcomes included adverse events, maternal and neonatal outcomes. RESULTS: Participants showed a significant improvement in glycaemic control after engaging in the intervention for 2weeks; the improvement was most significant in terms of the 2-h postprandial plasma glucose (p < 0.05). The fasting blood glucose and 2-h postprandial plasma glucose data indicated a higher glycaemic control rate in the experimental than control group (86.16% versus 66.67%, p = 0.008; and 84.62% versus 36.36% (6.09 +/- 0.79 versus 6.96 +/- 1.06mmol/L), p < 0.001, respectively). After delivery, the 2-h oral glucose tolerance test results indicated better glycaemic control in the experimental than control group (75.44% versus 57.41% (6.93 +/- 1.44 versus 7.79 +/- 2.03mmol/L), p = 0.047). Additionally, the 2-h oral glucose tolerance test in the experimental group with reasonable exercise frequency (>= 10 times per week) had the best glucose level (6.81 +/- 1.30mmol/L), followed by the experimental group with a lower exercise frequency (< 10 times per week) (7.35 +/- 1.83mmol/L) and the control group (7.79 +/- 2.03mmol/L). No statistical differences in maternal or neonatal outcomes were observed between the control and experimental groups (p > 0.05). In addition, there were no adverse events in the experimental group; however, in the control group, two cases experienced at least one hypoglycaemic episode and two cases received insulin during the study period. CONCLUSIONS: The original Gymnastics for Pregnant Women was associated with greater improvements in blood glucose levels during pregnancy and postpartum compared with a conventional intervention for women with gestational diabetes mellitus. REGISTRATION: ChiCTR2000033963 (2020-06-22). TWEETABLE ABSTRACT: The original Gymnastics for Pregnant Women program improves glycaemic control in GDM women but does not affect delivery outcomes.
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