National Cheng Kung University
Tainan, Taiwan, 701
Location status: Recruiting
NCT Number: NCT06284278
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.
Interested in participating?
Request Info20 year–65 year
Female
Interventional
Not applicable
Tainan, Taiwan, 701
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 weeks diaphragmatic breathing training
8 weeks pelvic stabilization exercise training
pelvic anatomy education
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
Time frame: Change from baseline to 8 weeks
Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)
Time frame: Change from baseline to 8 weeks
Ultrasonography image for mobility during maximum inspiration and expiration (M mode)
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
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.
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.
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.
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.
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).
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).
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
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
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
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.
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.
YI-JU TSAI
Other
Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05849649
Behavior, Motor Activity
Bowling Green, Kentucky, United States
View Trial DetailsNCT06560190
Behavior, Motor Activity
San Antonio, Texas, United States
View Trial DetailsNCT06298214
Postpartum, Pregnancy Related
Baton Rouge, Louisiana, United States
View Trial DetailsNCT03733405
Behavior, Breast Feeding
Los Angeles, California, United States
View Trial Details