Postpartum WomenNCT05144269
Telerehabilitation in Postpartum Women
A study testing Multimodal exercises in people with Postpartum Women and Telerehabilitation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Postpartum is a transitional period in which physical, social and emotional changes take place in the women. Especially the difficulty of psychological and physiological changes can be associated with deterioration in the women's health. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postpartum Women, Telerehabilitation
- What is being tested?
- Multimodal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 22 Jun 2022
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postpartum between 6-12 weeks
- giving birth to a healthy baby
- Having technological devices that can be connected online via video conferencing,
- women who can use technological devices to connect
Who cannot join
- Multiple pregnancy,
- Having other diseases that will affect their functions,
- Having a problem related to the musculoskeletal system (such as abdominal hernia) that will prevent exercise,
- having neurological, rheumatic disease
- having chronic pain
- Diastasis recti distance greater than 2 cm,
- Women whose babies were hospitalized during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Clinical Research Ethics Commitee
Antalya
About this study
Official title: Investigation of the Effects of Multimodal Exercise-Based Telerehabilitation on Psychosocial Factors in Postpartum Women
Postpartum is a transitional period in which physical, social and emotional changes take place in the women. Especially the difficulty of psychological and physiological changes can be associated with deterioration in the women's health. Exercise support programs given to postpartum women have been shown to contribute to physical, mental and social well-being. Statistically significant improvements were found in depression and anxiety symptoms, energy and fatigue parameters, and general health regarding the effects of exercise on mental health in pregnant and postpartum women. The recommendation of the American Association of Obstetricians and Gynecologists (ACOG) is that women start physical activity as soon as they are medically or obstetrically safe. It is stated that they can be included in the exercise programs as soon as possible if it is a normal delivery, and after the 6th week, except for certain exercises if it is a cesarean section. Literature mentioned that exercise studies with postpartum women are insufficient. These mostly focused on the postpartum period and women who had a cesarean section were excluded. In their studies comparing the clinical and virtual environment; Although there is no statistical difference, there are studies showing that it is superior. To the best knowledge, there were no studies on postpartum telerehabilitation. Literature with a multidimensional approach in line with the recommendations of the guidelines were also limited.
Read the detailed description
This study is a randomized controlled trial aiming to examine the improvement in psychosocial status and physical activity in postpartum women after 8 weeks of multimodal exercise-based telerehabilitation. Two groups will be formed, namely the intervention group and the training group.
Multimodal exercise-based telerehabilitation will be applied to the intervention group by an experienced physiotherapist in 45-minute sessions, 2 days a week, for 8 weeks; Postpartum and exercise related training will be given and they will be asked to walk gradually increasing aerobic exercises. All interventions are common except for the control group telerehabilitation. Women will be evaluated before and after the study. 'Edinburgh Postpartum Depression Scale (EPDS)', 'Fatigue Severity Scale (FSS)', 'Pittsburgh Sleep Quality Index (PUKI), 'World Health Organization Lifestyle' for depression, fatigue, sleep, quality of life, physical activity and mental health in evaluations. World Health Organization Quality of Life Scale (WHOQOL-BREF)', 'Kaiser Physical Activity Questionnaire (KFAA)', 'Short Symptom Inventory' will be used.
- Conditions
- Postpartum Women, Telerehabilitation
- Being tested
- Multimodal exercises
- Keywords
- Postpartum, Depression, Physical activity, Pilates, Telerehabilitasyon
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercisesOther
Telehabilitation including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Multimodal exercises group | Experimental | Multimodal exercise-based telerehabilitation will be implemented with video conference method. For telerehabilitation, a program including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises was created. Sessions consist of 45 minutes. Telerehabilitation will take place 2 days a week for 8 weeks. Receives: Other: Multimodal exercises |
| Education group | No intervention | 30 minutes of training will be given about postpartum and exercises. As exercise, only aerobic walking exercise, which can be started for 15 minutes a day and 3 days a week according to the guide, gradually increasing, up to 30 minutes and up to 4 days a week will be applied. There will also be a warm-up and a cool-down period before the walking exercise. *Exercise intensity is determined in the 12-14 score range according to the Borg Scale, and how to apply it will be explained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postpartum Depression Scale
The Edinburgh Postpartum Depression Scale, developed by Cox and Holden, is used to determine the risk of depression in the postpartum period and to measure the change in level and severity. The scale is a self-assessment scale consisting of 10 questions in 4-point Likert type. The scores obtained from the scale vary between 0-30. The cut-off point is 13 and those who score 13 and above are considered to have depression risk/suspicion.
Measured: 2 months
Kaiser Physical Activity Questionnaire
It was adapted from the Baecke Physical Activity Questionnaire to measure physical activity in women. In the scale, both how often the activities are done and how much time is spent on that activity are questioned. The survey consists of 38 questions in total. The questions in the survey are grouped under four main headings: "housework/care", "occupational", "active life", "sports and exercise". There are 11, 8, 4 and 15 questions in these categories, respectively. The questions are scored from 1 to 5. The scores of each category are averaged. It is then multiplied by the frequency, duration and MET value and summed up on all activities. The MET values of 3.5, 5 and 7, respectively, were used to represent the average MET values of activity in each intensity category. Categorical, total activity and weighted total activity scores are calculated.
Measured: 2 months
Short Symptom Inventory
It is a 53-item multidimensional symptom screening scale developed by Derogatis (1992). It consists of 9 subscales and 3 global indexes. These; It includes somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid thought, and psychoticism dimensions. The scoring of the items is in the liker type between 0 and 4. The total score range varies between "0-212". It is evaluated that the higher the score, the higher the frequency of mental symptoms. Subscale scores are obtained by dividing the sum of the scores given to the items forming each subscale by the number of items.
Measured: 2 months
Secondary outcomes (3)
World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF)
The scale evaluates physical, mental, social and environmental well-being and consists of 26 questions. Field scores range from 4 to 20, and the higher the score, the higher the quality of life.
Measured: 2 months
Fatigue Severity Scale
The Scale is shown as the best example among one-dimensional scales. Each item of the scale, which consists of 9 items that patients can apply to themselves, is scored between 1-7 and the total score is calculated by taking the average of 9 items. The cut-off value for pathological fatigue was determined as 4 and above. The lower total scores mean less fatigue.
Measured: 2 months
Pittsburgh Sleep Quality Index
The scale is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. It consists of 24 questions, 19 questions self-report questions, 5 questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start30 Nov 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin, PT, Akdeniz University
- Investigators
- Sebahat Yaprak Cetin, Asst Prof, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144269
- Sponsor's protocol ID
- 2021-400
- Status last verified
- Oct 2022
- First submitted
- 22 Nov 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Multimodal Exercise-Based Telerehabilitation on Psychosocial Factors in Postpartum Women
- ClinicalTrials.gov ID
- NCT05144269
- Acronym / sponsor ID
- 2021-400
- Conditions
- Postpartum Women, Telerehabilitation
- Keywords
- Postpartum, Depression, Physical activity, Pilates, Telerehabilitasyon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 3 Dec 2021 (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.
Postpartum is a transitional period in which physical, social and emotional changes take place in the women. Especially the difficulty of psychological and physiological changes can be associated with deterioration in the women's health. Exercise support programs given to postpartum women have been shown to contribute to physical, mental and social well-being. Statistically significant improvements were found in depression and anxiety symptoms, energy and fatigue parameters, and general health regarding the effects of exercise on mental health in pregnant and postpartum women. The recommendation of the American Association of Obstetricians and Gynecologists (ACOG) is that women start physical activity as soon as they are medically or obstetrically safe. It is stated that they can be included in the exercise programs as soon as possible if it is a normal delivery, and after the 6th week, except for certain exercises if it is a cesarean section. Literature mentioned that exercise studies with postpartum women are insufficient. These mostly focused on the postpartum period and women who had a cesarean section were excluded. In their studies comparing the clinical and virtual environment; Although there is no statistical difference, there are studies showing that it is superior. To the best knowledge, there were no studies on postpartum telerehabilitation. Literature with a multidimensional approach in line with the recommendations of the guidelines were also limited.
Detailed description
This study is a randomized controlled trial aiming to examine the improvement in psychosocial status and physical activity in postpartum women after 8 weeks of multimodal exercise-based telerehabilitation. Two groups will be formed, namely the intervention group and the training group.
Multimodal exercise-based telerehabilitation will be applied to the intervention group by an experienced physiotherapist in 45-minute sessions, 2 days a week, for 8 weeks; Postpartum and exercise related training will be given and they will be asked to walk gradually increasing aerobic exercises. All interventions are common except for the control group telerehabilitation. Women will be evaluated before and after the study. 'Edinburgh Postpartum Depression Scale (EPDS)', 'Fatigue Severity Scale (FSS)', 'Pittsburgh Sleep Quality Index (PUKI), 'World Health Organization Lifestyle' for depression, fatigue, sleep, quality of life, physical activity and mental health in evaluations. World Health Organization Quality of Life Scale (WHOQOL-BREF)', 'Kaiser Physical Activity Questionnaire (KFAA)', 'Short Symptom Inventory' will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multimodal exercises group | Experimental | Other: Multimodal exercisesMultimodal exercise-based telerehabilitation will be implemented with video conference method. For telerehabilitation, a program including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises was created. Sessions consist of 45 minutes. Telerehabilitation will take place 2 days a week for 8 weeks. |
| Education group | No intervention | –30 minutes of training will be given about postpartum and exercises. As exercise, only aerobic walking exercise, which can be started for 15 minutes a day and 3 days a week according to the guide, gradually increasing, up to 30 minutes and up to 4 days a week will be applied. There will also be a warm-up and a cool-down period before the walking exercise. *Exercise intensity is determined in the 12-14 score range according to the Borg Scale, and how to apply it will be explained. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum between 6-12 weeks
- giving birth to a healthy baby
- Having technological devices that can be connected online via video conferencing,
- women who can use technological devices to connect
Key exclusion criteria (7 listed)
- Multiple pregnancy,
- Having other diseases that will affect their functions,
- Having a problem related to the musculoskeletal system (such as abdominal hernia) that will prevent exercise,
- having neurological, rheumatic disease
- having chronic pain
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 |
|---|---|---|
| Multimodal exercisesTelehabilitation including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises | Other | Multimodal exercises group |
Primary outcome
Edinburgh Postpartum Depression Scale
Time frame: 2 months
The Edinburgh Postpartum Depression Scale, developed by Cox and Holden, is used to determine the risk of depression in the postpartum period and to measure the change in level and severity. The scale is a self-assessment scale consisting of 10 questions in 4-point Likert type. The scores obtained from the scale vary between 0-30. The cut-off point is 13 and those who score 13 and above are considered to have depression risk/suspicion.
Kaiser Physical Activity Questionnaire
Time frame: 2 months
It was adapted from the Baecke Physical Activity Questionnaire to measure physical activity in women. In the scale, both how often the activities are done and how much time is spent on that activity are questioned. The survey consists of 38 questions in total. The questions in the survey are grouped under four main headings: "housework/care", "occupational", "active life", "sports and exercise". There are 11, 8, 4 and 15 questions in these categories, respectively. The questions are scored from 1 to 5. The scores of each category are averaged. It is then multiplied by the frequency, duration and MET value and summed up on all activities. The MET values of 3.5, 5 and 7, respectively, were used to represent the average MET values of activity in each intensity category. Categorical, total activity and weighted total activity scores are calculated.
Short Symptom Inventory
Time frame: 2 months
It is a 53-item multidimensional symptom screening scale developed by Derogatis (1992). It consists of 9 subscales and 3 global indexes. These; It includes somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid thought, and psychoticism dimensions. The scoring of the items is in the liker type between 0 and 4. The total score range varies between "0-212". It is evaluated that the higher the score, the higher the frequency of mental symptoms. Subscale scores are obtained by dividing the sum of the scores given to the items forming each subscale by the number of items.
3 secondary outcomes
World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF)
Time frame: 2 months
Fatigue Severity Scale
Time frame: 2 months
Pittsburgh Sleep Quality Index
Time frame: 2 months
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 12 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Postpartum Women
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
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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.
Sebahat Yaprak Cetin, Asst Prof principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal exercises in people with Postpartum Women and Telerehabilitation, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 7 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 12 Oct 2022. 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 Turkey (Türkiye). 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?
Edinburgh Postpartum Depression Scale (time frame: 2 months). The study lists 3 primary outcomes in all. 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 12 Oct 2022.