NCT06268782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 12, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

digital health interventionehealthexercisemotherphysical activitypostpartumquality of lifeurinary incontinencepelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    The primary outcome, quality of life, was measured with The World Health Organization Quality of Life (WHOQOL-BREF) instrument. The WHOQOL-BREF is a 26-item assessment instrument, which purpose is to assess individuals' perceptions of their position in life relation to their goals, expectations, standards and concerns. The first two items of WHOQOL-BREF measure the overall QoL and general health. The rest of the items of WHOQOL-BREF are divided into four different domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Each item is rated on a 5-point Likert scale (a low score of 1 to a high score of 5). Data were analyzed according to the scoring guideline. During the data processing, the raw item score of each domain was calculated, and then the domain raw scores were converted to a scale from 0 to 100, where a higher score represented a higher QoL.

    From enrollment to the end of follow-up period 6 months after the intervention

Secondary Outcomes (3)

  • Physical activity

    From enrollment to the end of follow-up period 6 months after the intervention

  • Urinary incontinence

    From enrollment to the end of follow-up period 6 months after the intervention

  • Pelvic organ prolapse

    From enrollment to the end of follow-up period 6 months after the intervention

Study Arms (1)

The intervention group

EXPERIMENTAL

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.

Behavioral: Rehabilitate your core

Interventions

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.

The intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Turku, 20014, Finland

Location

MeSH Terms

Conditions

Motor ActivityUrinary IncontinencePelvic Organ Prolapse

Condition Hierarchy (Ancestors)

BehaviorUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProlapsePathological Conditions, Anatomical

Study Officials

  • Anna Axelin, PhD

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral researcher

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

September 21, 2021

Primary Completion

January 24, 2023

Study Completion

September 19, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

The data that we collected were really personal and sensitive and the participants were considered as vulnerable group as study participants, so we decided not to share the data.

Locations