Quality of LifeNCT06268782
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
A study testing Rehabilitate your core in people with Quality of Life and Physical Activity, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Physical Activity, Urinary Incontinence
- What is being tested?
- Rehabilitate your core
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteFinland
- Study dates
- 21 Sep 2021to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Nursing Science, Faculty of Medicine, University of Turku
Turku, 20014
About this study
Official title: Online Training Program for Postpartum Women - How to Effectively Enhance the Well-being and Recovery After Pregnancy and Delivery
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.
Read the 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.
- Being tested
- Rehabilitate your core
- Keywords
- digital health intervention, ehealth, exercise, mother, physical activity, postpartum, quality of life, urinary incontinence, pelvic organ prolapse
- Medical subject headings
- Motor Activity, Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitate your coreBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Rehabilitate your core |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-up period 6 months after the intervention
Secondary outcomes (3)
Physical activity
PA was measured with the International Physical Activity Questionnaire Short Form (IPAQ-SF) instrument. The IPAQ-SF is a 7-item assessment instrument whose purpose is to assess the types of the intensity of PA and sitting time that people perform as a part of their daily lives. Participants were asked to address the number of days and the time that they spent on PA in moderate and vigorous intensity and walking during the last 7 days. The scores are expressed in PA metabolic equivalent of task (MET) minutes per week. Time spent sitting is calculated as time per day and week. Data from IPAQ-SF were analyzed according to the scoring guideline so, that in the end of the data processing the data related to PA were described as followed: walking MET minutes per week, moderate MET minutes per week, vigorous MET minutes per week and total MET minutes per week.
Measured: From enrollment to the end of follow-up period 6 months after the intervention
Urinary incontinence
The urinary incontinence was measured with two instruments that are recommended to use together: Incontinence Impact Questionnaire IIQ-7 (short version of the original instrument) and Urogenital distress inventory UDI-6 (short version of the original instrument). These two instruments include altogether 13 items with Likert scales (with item responses 0 for "not at all" to 3 "greatly") and the instruments are used to research the impact on the quality of life of incontinence symptoms in women.
Measured: From enrollment to the end of follow-up period 6 months after the intervention
Pelvic organ prolapse
Symptoms of pelvic organ prolapse were measured with five questions. There were three questions regarding the prevalence of prolapse symptoms with options yes/no, which were retrieved from the Urogenital distress inventory -instrument's full version, and two questions evaluated with VAS, which goal were to assess the severity of the symptoms.
Measured: From enrollment to the end of follow-up period 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start21 Sep 2021
- Primary completion24 Jan 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Cultural Foundation
- Responsible party
- Principal investigator, Iina Ryhta, University of Turku
- Investigators
- Anna Axelin, PhD, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268782
- Sponsor's protocol ID
- 1204202118
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Training Program for Postpartum Women - How to Effectively Enhance the Well-being and Recovery After Pregnancy and Delivery
- ClinicalTrials.gov ID
- NCT06268782
- Acronym / sponsor ID
- 1204202118
- Keywords
- digital health intervention, ehealth, exercise, mother, physical activity, postpartum, quality of life, urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Finnish Cultural Foundation
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Rehabilitate your coreAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitate your coreThe 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. | Behavioural | The intervention group |
Primary outcome
Quality of Life
Time frame: From enrollment to the end of follow-up period 6 months after the intervention
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.
3 secondary outcomes
Physical activity
Time frame: From enrollment to the end of follow-up period 6 months after the intervention
Urinary incontinence
Time frame: From enrollment to the end of follow-up period 6 months after the intervention
Pelvic organ prolapse
Time frame: From enrollment to the end of follow-up period 6 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Axelin, PhD study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitate your core in people with Quality of Life and Physical Activity, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: From enrollment to the end of follow-up period 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.