PostpartumNCT06284278
Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain
A study testing Diaphragmatic breathing retraining, Pelvic stabilization exercise and pelvic anatomy education in people with Postpartum and Pregnancy Related, run by YI-JU TSAI at 1 site in Taiwan.
Trial summary
The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Postpartum, Pregnancy Related, Pelvic Girdle Pain
- What is being tested?
- Diaphragmatic breathing retraining, Pelvic stabilization exercise and pelvic anatomy education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-65 years
- Postpartum ≥ 3 months
- Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)
- Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)
- At least 2 positive findings of 6 pain provocation tests for pelvic pain
- Score of Active Straight Leg Rise (ASLR) test > 0
Who cannot join
- being pregnant or actively trying to get pregnant
- having known causes of pelvic girdle pain, such as fractures and rheumatism
- having undergone lumbar, pelvic, gynecologic or obstetric surgery
- having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
- having cancer
- having cardiovascular disease
Show all 9Show fewer
- being diagnosed as having a psychiatric disease
- active infection or infectious disease in the pelvis or abdomen
- having experience with structured and supervised core or trunk exercise training programs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, Taiwan, 701
Tsai Yi-Ju, 06-2353535 ext. 5930, lulilutsai@gmail.com
About this study
Official title: Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention
The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.
- Conditions
- Postpartum, Pregnancy Related, Pelvic Girdle Pain
- Being tested
- Diaphragmatic breathing retraining, Pelvic stabilization exercise, pelvic anatomy education
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing retrainingOther
8 weeks diaphragmatic breathing training
Pelvic stabilization exerciseOther
8 weeks pelvic stabilization exercise training
pelvic anatomy educationOther
pelvic anatomy education
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing exercise group | Experimental | Diaphragmatic breathing exercise through telehealth Receives: Other: Diaphragmatic breathing retraining; Other: pelvic anatomy education |
| Pelvic stabilization exercise group | Active comparator | Pelvic stabilization exercise through telehealth Receives: Other: Pelvic stabilization exercise; Other: pelvic anatomy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function measures of lumbopelvic muscles
Ultrasonography image for muscle thickness of trunk and back muscles during rest and during active straight leg raise.
Ultrasonography image for bladder displacement for pelvic floor muscles during rest,maximum contraction and during active straight leg raise
Measured: Change from baseline to 8 weeks
Diaphragm thickness
Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)
Measured: Change from baseline to 8 weeks
Diaphragm mobility
Ultrasonography image for mobility during maximum inspiration and expiration (M mode)
Measured: Change from baseline to 8 weeks
Diaphragm strength
Ultrasonography image for diaphragm strength during maximal sniff and expiration (M mode). The slope achieved (mm/sec) during the diaphragmatic excursion is used to calculate the velocity of the diaphragmatic contraction
Measured: Change from baseline to 8 weeks
Mechanical Property of Thoracolumbar Fascia
The biomechanical and viscoelastic properties of the muscles will be measured using a non-invasive myometer. It automatically calculate and provide the biomechanical and viscoelastic properties of stiffness, frequency, decrement, and stress relaxation time that offer the information of tone, elasticity, stiffness and stress relaxation time of the tested tissue.
Measured: Change from baseline to 8 weeks
Functional performance of ASLR fatigue task
Participants lifted the heel of the test leg to 20 cm for as long as possible. Participants were required to maintain pressure in the cuff beneath their back as close to 40 mm Hg as possible. Visual feedback of cuff pressure was provided throughout the task, but no instruction was given on how to affect cuff pressure. Task failure was defi ned as an inability to maintain heel height 10 cm or more off the plinth and/or a change in cuff pressure of 20 mm Hg or more.
Measured: Change from baseline to 8 weeks
Functional performance of timed up and go test
Test instructions were given in Norwegian. Translated into English, the instructions were as follows: 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.
'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.
Measured: Change from baseline to 8 weeks
Functional performance of 6m timed walk test
Subjects commenced the test in standing with their toes up against the tape marker. Test instructions translated into English were as follows: 'After "ready, set, go", walk as fast as you can up to the last white line without stopping or speaking along the way'. Performances were timed (to the nearest 100th of a second) between the 2m and 8m markers and later converted into speed in metres per second.
Measured: Change from baseline to 8 weeks
pain intensity measure of Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).
Measured: Change from baseline to 8 weeks
Disability Level: measure of pelvic girdle questionnaire(PGQ)
pelvic girdle questionnaire(PGQ) is a self-reported instrument assessing pelvic girdle pain intensity in currently. Questionnaire consisting of 20 activity items and 5 symptom items on a 4-point response scale. Possible score range from 0 (no pain) to 100 (worst possible pain).
Measured: Change from baseline to 8 weeks
Health-related Quality of Life: Short Form-36 (SF36)
SF-36 include 36 questions constructing into 8 domains (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). The scores of physical and mental components and total are ranged from 0 to 100, with higher scores representing better quality of life
Measured: Change from baseline to 8 weeks
Fear Avoidance Belief: Tampa Scale of Kinesiophobia
Fear of movement, fear of physical activity, and fear avoidance will be assessed using the Tampa scale of kinesiophobia (TSK). The TSK is 17-items questionnaire, where patients rate their agreement using 4-points scale. It consists of two subscales including activity avoidance to reflect the activity that may result in an increase in pain or cause injury, and somatic focus to reflect the beliefs and underlying serious conditions
Measured: Change from baseline to 8 weeks
Self-Efficacy: Pain Self-efficacy Questionnaire
The pain self-efficacy questionnaire (PSEQ) is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores of the PSEQ is 60 points and a higher score indicates more self-efficacy
Measured: Change from baseline to 8 weeks
Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)
The PSI-SF is a self-reported questionnaire that consists of 36 items to assess stress related to three aspects including parent-child relationship, parental distress, and difficulties in the parent-child interaction. The subscales for parental distress, parent-child dysfunctional interaction and difficult child, as well as the total stress scale are rated from 1 (strongly disagree) to 5 (strongly agree). The higher the score indicates the greater the stress.
Measured: Change from baseline to 8 weeks
Self-perceived Change: Global Rating of Change Scale (GROC)
The GROC rates perceived "overall change" on a 15-point Likert scale, with 7 (labeled "worse") on the left, +7 (labeled "better") on the right, and 0 in the middle (labeled "no change") compared to the baseline.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YI-JU TSAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284278
- Sponsor's protocol ID
- NCKU_PPGP_diaphragm
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention
- ClinicalTrials.gov ID
- NCT06284278
- Acronym / sponsor ID
- NCKU_PPGP_diaphragm
- Conditions
- Postpartum, Pregnancy Related, Pelvic Girdle Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- YI-JU TSAIUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 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 goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing exercise group | Experimental | Other: Diaphragmatic breathing retraining, Other: pelvic anatomy educationDiaphragmatic breathing exercise through telehealth |
| Pelvic stabilization exercise group | Active comparator | Other: Pelvic stabilization exercise, Other: pelvic anatomy educationPelvic stabilization exercise through telehealth |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 20-65 years
- Postpartum ≥ 3 months
- Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)
- Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)
- At least 2 positive findings of 6 pain provocation tests for pelvic pain
Key exclusion criteria (9 listed)
- being pregnant or actively trying to get pregnant
- having known causes of pelvic girdle pain, such as fractures and rheumatism
- having undergone lumbar, pelvic, gynecologic or obstetric surgery
- having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
- having cancer
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 |
|---|---|---|
| Diaphragmatic breathing retraining8 weeks diaphragmatic breathing training | Other | Diaphragmatic breathing exercise group |
| Pelvic stabilization exercise8 weeks pelvic stabilization exercise training | Other | Pelvic stabilization exercise group |
| pelvic anatomy educationpelvic anatomy education | Other | Diaphragmatic breathing exercise group, Pelvic stabilization exercise group |
Primary outcome
Muscle function measures of lumbopelvic muscles
Time frame: Change from baseline to 8 weeks
Ultrasonography image for muscle thickness of trunk and back muscles during rest and during active straight leg raise. Ultrasonography image for bladder displacement for pelvic floor muscles during rest,maximum contraction and during active straight leg raise
Diaphragm thickness
Time frame: Change from baseline to 8 weeks
Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)
Diaphragm mobility
Time frame: Change from baseline to 8 weeks
Ultrasonography image for mobility during maximum inspiration and expiration (M mode)
Diaphragm strength
Time frame: Change from baseline to 8 weeks
Ultrasonography image for diaphragm strength during maximal sniff and expiration (M mode). The slope achieved (mm/sec) during the diaphragmatic excursion is used to calculate the velocity of the diaphragmatic contraction
Mechanical Property of Thoracolumbar Fascia
Time frame: Change from baseline to 8 weeks
The biomechanical and viscoelastic properties of the muscles will be measured using a non-invasive myometer. It automatically calculate and provide the biomechanical and viscoelastic properties of stiffness, frequency, decrement, and stress relaxation time that offer the information of tone, elasticity, stiffness and stress relaxation time of the tested tissue.
Functional performance of ASLR fatigue task
Time frame: Change from baseline to 8 weeks
Participants lifted the heel of the test leg to 20 cm for as long as possible. Participants were required to maintain pressure in the cuff beneath their back as close to 40 mm Hg as possible. Visual feedback of cuff pressure was provided throughout the task, but no instruction was given on how to affect cuff pressure. Task failure was defi ned as an inability to maintain heel height 10 cm or more off the plinth and/or a change in cuff pressure of 20 mm Hg or more.
Functional performance of timed up and go test
Time frame: Change from baseline to 8 weeks
Test instructions were given in Norwegian. Translated into English, the instructions were as follows: 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position. 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.
Functional performance of 6m timed walk test
Time frame: Change from baseline to 8 weeks
Subjects commenced the test in standing with their toes up against the tape marker. Test instructions translated into English were as follows: 'After "ready, set, go", walk as fast as you can up to the last white line without stopping or speaking along the way'. Performances were timed (to the nearest 100th of a second) between the 2m and 8m markers and later converted into speed in metres per second.
pain intensity measure of Numeric Rating Scale (NRS)
Time frame: Change from baseline to 8 weeks
Numeric Rating Scale (NRS) is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).
Disability Level: measure of pelvic girdle questionnaire(PGQ)
Time frame: Change from baseline to 8 weeks
pelvic girdle questionnaire(PGQ) is a self-reported instrument assessing pelvic girdle pain intensity in currently. Questionnaire consisting of 20 activity items and 5 symptom items on a 4-point response scale. Possible score range from 0 (no pain) to 100 (worst possible pain).
Health-related Quality of Life: Short Form-36 (SF36)
Time frame: Change from baseline to 8 weeks
SF-36 include 36 questions constructing into 8 domains (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). The scores of physical and mental components and total are ranged from 0 to 100, with higher scores representing better quality of life
Fear Avoidance Belief: Tampa Scale of Kinesiophobia
Time frame: Change from baseline to 8 weeks
Fear of movement, fear of physical activity, and fear avoidance will be assessed using the Tampa scale of kinesiophobia (TSK). The TSK is 17-items questionnaire, where patients rate their agreement using 4-points scale. It consists of two subscales including activity avoidance to reflect the activity that may result in an increase in pain or cause injury, and somatic focus to reflect the beliefs and underlying serious conditions
Self-Efficacy: Pain Self-efficacy Questionnaire
Time frame: Change from baseline to 8 weeks
The pain self-efficacy questionnaire (PSEQ) is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores of the PSEQ is 60 points and a higher score indicates more self-efficacy
Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)
Time frame: Change from baseline to 8 weeks
The PSI-SF is a self-reported questionnaire that consists of 36 items to assess stress related to three aspects including parent-child relationship, parental distress, and difficulties in the parent-child interaction. The subscales for parental distress, parent-child dysfunctional interaction and difficult child, as well as the total stress scale are rated from 1 (strongly disagree) to 5 (strongly agree). The higher the score indicates the greater the stress.
Self-perceived Change: Global Rating of Change Scale (GROC)
Time frame: Change from baseline to 8 weeks
The GROC rates perceived "overall change" on a 15-point Likert scale, with 7 (labeled "worse") on the left, +7 (labeled "better") on the right, and 0 in the middle (labeled "no change") compared to the baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing retraining, Pelvic stabilization exercise and pelvic anatomy education in people with Postpartum and Pregnancy Related, run by YI-JU TSAI at 1 site in Taiwan.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle function measures of lumbopelvic muscles (time frame: Change from baseline to 8 weeks). The study lists 15 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 6 Jul 2026.