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Preliminary effectiveness of mhealth app-based pelvic floor muscle training among pregnant women to improve their exercise adherence: a pilot randomised control trial |
Jaffar A, Mohd Sidik S, Foo CN, Muhammad NA, Abdul Manaf R, Suhaili N |
International Journal of Environmental Research & Public Health 2022 Feb;19(4):2332 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: 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* |
This pilot randomised control trial (RCT) aimed to evaluate the feasibility and preliminary effectiveness of conducting a full-powered trial for a newly developed pelvic floor muscle training (PFMT) app among pregnant women with urinary incontinence (UI) in Malaysia. This was a prospective, single-centre, single-blind, parallel, randomised controlled, pilot feasibility study-the Kegel exercise pregnancy training app (KEPT app) trial. In total, 26 pregnant women with urinary incontinence from an urban healthcare clinic were recruited and randomly assigned to either intervention or waitlist control group. The intervention group received the KEPT app, while the control group received usual antenatal care (waitlist control). Of the 26 pregnant women, 16 (61.5%) completed the two-month follow-up. The recruitment rate was 54.2%, and the retention rate was 62.5% in the intervention group and 60% in the control group. There was a significant difference between intervention and control groups' baseline measurement in the severity of UI (p = 0.031). The app improved their knowledge (p = 0.011) and self-efficacy (p = 0.038) after the first month and attitude (p = 0.034) after two months of intervention, compared with the control group. This study supports the feasibility of our future cluster RCT. The KEPT app demonstrates a promising effect in improving PFMT attitude and self-efficacy and potentially enhancing exercise adherence among pregnant women with UI. TRIAL REGISTRATION: Prospectively registered on ClinicalTrials.gov on 19 February 2021 NCT04762433.
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