Clinical trial NCT06268782: The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
Official title: Online Training Program for Postpartum Women - How to Effectively Enhance the Well-being and Recovery After Pregnancy and Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Physical Activity
Urinary Incontinence
Pelvic Organ Prolapse
Keywords: digital health intervention
ehealth
exercise
mother
physical activity
postpartum
quality of life
urinary incontinence
pelvic organ prolapse
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Finnish Cultural Foundation
First posted: 2024-02-20
Enrollment: 308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023.

Detailed description: The aim of this study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and symptoms of urinary incontinence (UI) and pelvic organ prolapse (POP) of postpartum women immediately and 6 months after the online intervention. The hypothesis was that the online exercise program increases PA, which consequently improves QoL and decreases the symptoms of UI and POP immediately and 6 months after the intervention.

This study was a quasi-experimental study with pre- and posttest design, without a control group. It was carried out in Finland between September 2021 and September 2023. Data were collected with e-questionnaires at the baseline (pretest), immediately after the intervention (posttest), and 6 months after the intervention (6-month follow-up). Ethical approval for this study was obtained from the Ethics Committee for Human Sciences at the University of Turku in June 2021.

The intervention was a Finnish-language online exercise program "Rehabilitate your core" developed for postpartum women by a company called Nordic Fit Mama. The program aims to strengthen the core and pelvic floor muscles for enhancing recovery after pregnancy and birth, but overall well-being is also considered throughout the program. The program is built on a webpage and is planned to be accomplished independently in 6 weeks. Every week has a specific theme, which includes six to seven subthemes. The program is progressive.

The study participants were recruited via the webpage of the online exercise program and every person participating in the online exercise program between September 2021 and January 2023 were invited to participate in this study. The eligibility criteria were: an age ≥18; a maximum of 2 years from the last birth; a complete postnatal examination (usually done 5-12 weeks after birth); fluency in Finnish; and the ability to pay for access to the online exercise program.

The sample size was determined by the WHOQOL-BREF instrument used in previous studies, as QoL was the primary outcome of this study. Based on power analysis, a total of 127 participants were required to detect a difference between baseline, pretest, and posttest measures. Considering the loss to follow-up, the sample size was increased to 303 at the baseline.

Data were collected with REDCap e-questionnaires that consisted of demographic data and validated instruments (The World Health Organization Quality of Life (WHOQOL-BREF), Physical Activity Questionnaire Short Form (IPAQ-SF), Incontinence Impact Questionnaire IIQ-7 and Urogenital distress inventory UDI-6).

Descriptive statistics (means, standard deviations or medians, frequencies, and percentages) were used to summarize the demographic data. The statistical analysis of the changes of mean or median scores of primary and secondary outcomes were tested using the Wilcoxon signed-rank test or paired samples t-test. Correlations between demographic data and the outcomes were tested with Pearsons and Spearmans correlations, the independent samples t-test, the Mann-Whitney U test, the one-way ANOVA, or the Kruskal-Wallis tests. The level of statistical significance was set at p≤.05. The data were analyzed using the IBM SPSS Statistics® program, version 28.

Eligibility criteria: Inclusion Criteria:

* a maximum of 2 years from the last birth
* a complete postnatal examination (usually 5-12 weeks after birth)
* the ability to pay for access to the online exercise program
* fluency in Finnish

Exclusion Criteria:

Primary outcomes:
measure: Quality of Life
timeFrame: From enrollment to the end of follow-up period 6 months after the intervention
Secondary outcomes:
measure: Physical activity
timeFrame: From enrollment to the end of follow-up period 6 months after the intervention
measure: Urinary incontinence
timeFrame: From enrollment to the end of follow-up period 6 months after the intervention
measure: Pelvic organ prolapse
timeFrame: From enrollment to the end of follow-up period 6 months after the intervention
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Nursing Science, Faculty of Medicine, University of Turku
Study officials:
affiliation: University of Turku
name: Anna Axelin, PhD
role: STUDY_DIRECTOR
References: