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RecruitingNCT06284278Updated Jul 6, 2026

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

An interventional study of Diaphragmatic breathing retraining and Pelvic stabilization exercise in Postpartum, Pregnancy Related and Pelvic Girdle Pain, sponsored by YI-JU TSAI. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by YI-JU TSAI · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
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Study 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.

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Conditions studied

  • Postpartum
  • Pregnancy Related
  • Pelvic Girdle Pain

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03

In context

Pelvic Girdle Pain

63 studies on the registry are indexed under Pelvic Girdle Pain; 14 are open to participants now.

This study's planned enrollment of 60 is above the median of 53 across 45 interventional studies indexed under Pelvic Girdle Pain.

Browse Pelvic Girdle Pain studies →

Lead sponsor

YI-JU TSAI is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Diaphragmatic breathing exercise group

    Diaphragmatic breathing exercise through telehealth

    Other: Diaphragmatic breathing retraining · Other: pelvic anatomy education

  • Active comparator
    Pelvic stabilization exercise group

    Pelvic stabilization exercise through telehealth

    Other: Pelvic stabilization exercise · Other: pelvic anatomy education

Interventions

  • OtherDiaphragmatic breathing retraining

    8 weeks diaphragmatic breathing training

  • OtherPelvic stabilization exercise

    8 weeks pelvic stabilization exercise training

  • Otherpelvic anatomy education

    pelvic anatomy education

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from baseline to 8 weeks

  2. Diaphragm thickness

    Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)

    Time frame: Change from baseline to 8 weeks

  3. Diaphragm mobility

    Ultrasonography image for mobility during maximum inspiration and expiration (M mode)

    Time frame: Change from baseline to 8 weeks

  4. 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

    Time frame: Change from baseline to 8 weeks

  5. 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.

    Time frame: Change from baseline to 8 weeks

  6. 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.

    Time frame: Change from baseline to 8 weeks

  7. 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.

    Time frame: Change from baseline to 8 weeks

  8. 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.

    Time frame: Change from baseline to 8 weeks

  9. 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).

    Time frame: Change from baseline to 8 weeks

  10. 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).

    Time frame: Change from baseline to 8 weeks

  11. 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

    Time frame: Change from baseline to 8 weeks

  12. 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

    Time frame: Change from baseline to 8 weeks

  13. 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

    Time frame: Change from baseline to 8 weeks

  14. 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.

    Time frame: Change from baseline to 8 weeks

  15. 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.

    Time frame: Change from baseline to 8 weeks

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06284278
Lead sponsor
YI-JU TSAI
Responsible party
YI-JU TSAI (professor, National Cheng Kung University) — Sponsor-investigator
First posted
Feb 28, 2024
Start date
Mar 1, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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