The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women

NCT ID: NCT06268782

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2023-09-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Physical Activity Urinary Incontinence Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The intervention group

All participants belonged to the intervention group. The participants were asked to answer for the pretest questionnaire before the intervention, then accomplish the six-week intervention, answer to the posttest questionnaire after the intervention and answer to the follow-up questionnaire six months after the intervention.

Group Type EXPERIMENTAL

Rehabilitate your core

Intervention Type BEHAVIORAL

The intervention was an online exercise program \"Rehabilitate your core,\" designed for postpartum women by a company called Nordic Fit Mama. Its primary goal is to fortify the core and pelvic floor muscles to enhance the recovery process after childbirth, while also emphasizing overall well-being. The program is accessible through a website and is intended to be completed independently over a span of 6 weeks. Each week focuses on a specific theme, encompassing six to seven subtopics. The regimen follows a progressive structure, starting with the identification of pelvic floor and core muscles and gradually advancing to exercises aimed at strengthening them. The exercises, which last around 10 minutes each, are tailored to integrate seamlessly into daily life. Comprising 25 instructional exercise videos and 13 guidance videos, the program only necessitates access to a device for logging into the platform.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rehabilitate your core

The intervention was an online exercise program \"Rehabilitate your core,\" designed for postpartum women by a company called Nordic Fit Mama. Its primary goal is to fortify the core and pelvic floor muscles to enhance the recovery process after childbirth, while also emphasizing overall well-being. The program is accessible through a website and is intended to be completed independently over a span of 6 weeks. Each week focuses on a specific theme, encompassing six to seven subtopics. The regimen follows a progressive structure, starting with the identification of pelvic floor and core muscles and gradually advancing to exercises aimed at strengthening them. The exercises, which last around 10 minutes each, are tailored to integrate seamlessly into daily life. Comprising 25 instructional exercise videos and 13 guidance videos, the program only necessitates access to a device for logging into the platform.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Finnish Cultural Foundation

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Iina Ryhta

Doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Axelin, PhD

Role: STUDY_DIRECTOR

University of Turku

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nursing Science, Faculty of Medicine, University of Turku

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1204202118

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promoting Aging in Place Through A Wellness Program
NCT06569576 ACTIVE_NOT_RECRUITING NA