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Pelvic Girdle PainNCT05879575

Effects and Pathophysiology of Weight Training on Pregnancy-related Pelvic Girdle Pain (PPGP)

A study testing weight training in people with Pelvic Girdle Pain, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In recent years, due to the popularity of exercise during pregnancy, the American College of Obstetricians and Gynecologists recommends that pregnant women should engage in 150 minutes of moderate-intensity exercise per week, including aerobic exercise or weight training. Read more about this study

Who is it for?
Ages 20 to 50 years, women only
Conditions the study is for
Pelvic Girdle Pain
What is being tested?
weight training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTaiwan
Study dates
31 May 2023to 1 Oct 2024
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 20 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women who are within 14 weeks of gestation and carrying a single fetus.
  • Pregnant women who can clearly identify the location of their pelvic girdle pain (e.g. sacroiliac joint or pubic symphysis pain).
  • Pregnant women who have at least one positive result in a front pelvic girdle pain test or two positive results in a back pelvic girdle pain test based on the "Self-Administered Pelvic Girdle Pain Test".
  • Pregnant women assigned to the intervention group must be able to comply with the exercise program.
  • Pregnant women assigned to the control group must not engage in weight training.
  • Definition of weight training: The use of resistance to induce muscular contraction, with the goal of increasing strength and endurance of the muscles. This can be achieved systematically using weights, such as one's own body weight, or equipment that provides resistance to muscle contraction, such as dumbbells, barbells, or resistance bands.
  • Participants will receive follow-up care and delivery at National Taiwan University Hospital in Hsinchu.

Who cannot join

  • For pregnant women with twins or multiple pregnancies
  • With any pregnancy exercise contraindications from the American College of Obstetricians and Gynecologists, including:
  • Pre-existing internal medical conditions such as severe unstable heart disease, restrictive lung disease, symptomatic severe anemia, poorly controlled hypertension, poorly controlled diabetes, poorly controlled thyroid disease, and other similar conditions.
  • Pregnancy-related conditions such as early rupture of membranes, signs of preterm labor, incomplete cervix closure, history of cervical cerclage, habitual miscarriage, and previous history of preterm birth.
  • History of spinal or pelvic surgery
  • Known pelvic pain before pregnancy, such as lumbar or pelvic fractures or chronic pain caused by previous surgery
Show all 11Show fewer
  • Clear diagnosis of pre-pregnancy back pain causes, such as herniated discs or nerve root diseases
  • Regular use of pain relief medications before pregnancy, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), morphine, and platelet-rich plasma (PRP) therapy
  • Regular weight training habit before enrollment (at least twice a week)
  • Not planning to give birth at National Taiwan University Hospital
  • Already participating in other interventional clinical trials.

Trial locations and contacts

1 site in 1 country.

KUAN YING HUANG contact

+886972653739

G01356@hch.gov.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu

    KUAN YING HUANG, +886916086623, G01356@hch.gov.tw

    Recruiting

Other trials in Taiwan

About this study

In recent years, due to the popularity of exercise during pregnancy, the American College of Obstetricians and Gynecologists recommends that pregnant women should engage in 150 minutes of moderate-intensity exercise per week, including aerobic exercise or weight training. This can help reduce pregnancy complications (such as preeclampsia, gestational diabetes, pelvic pain, etc.) and does not increase the risk of miscarriage or premature birth. Pelvic pain during pregnancy is the most troublesome problem for pregnant women, often affecting their daily lives and mental health, leading to the need for long-term use of painkillers and even affecting their daily routine and sleep. Currently, research has also found that exercise during pregnancy can improve pelvic pain during pregnancy and reduce the inconvenience caused by pain in daily life. However, weight training can strengthen spinal stability and reduce lower back pain problems in non-pregnant individuals, but there is currently no research discussing whether weight training for pregnant women can improve pelvic pain during pregnancy, possibly because weight training for pregnant women is not widely accepted by society and is often associated with misconceptions and prejudices. Recent literature synthesis analysis tells us that weight training during pregnancy does not increase the risk of premature birth or miscarriage. Pregnant women in supervised moderate-intensity weight training do not endanger the health of the mother or fetus, and the safety is sufficient. Therefore, we hope to understand the effects and mechanisms of weight training during pregnancy on pelvic pain during pregnancy through this study.

Read the detailed description

Pregnancy-related pelvic girdle pain is one of the most troubling issues for pregnant women. Everyday activities, such as walking, standing, sitting, and even lying down, can potentially trigger or exacerbate the pain. The diagnostic criteria for pelvic girdle pain are relatively complex. Since the 2008 European guidelines suggested clinical physiotherapy test conditions, they have gradually been adapted for pregnant women. In 2021, Monika revised the diagnostic criteria, allowing pregnant women to self-check for pelvic girdle pain diagnosis, with the following self-test conditions:

Pregnant women have experienced at least one day in the past four weeks when pelvic girdle pain has affected their daily lives.

They can clearly point out the painful area (e.g., sacroiliac joint or pubic symphysis joint pain).

At least one positive anterior pelvic girdle pain test item, or two positive posterior pelvic girdle pain test items, are confirmed through a "pelvic girdle pain self-check." Research has found that 50-70% of pregnant women experience pelvic girdle pain during pregnancy, with 33%-50% experiencing pain even before 20 weeks of gestation. However, 7% continue to have pelvic girdle pain issues for life after childbirth. Pregnancy-related pelvic girdle pain affects daily life and mental health, often leading to long-term use of painkillers and affecting daily routines and sleep.

Recent research suggests that weight training can strengthen spinal stability and reduce lower back pain in non-pregnant individuals. The American College of Obstetricians and Gynecologists recommends pregnant women engage in 150 minutes of moderate-intensity exercise per week, including aerobic exercise or weight training. Studies also show that exercising during pregnancy can improve pelvic girdle pain, reducing inconvenience in daily life, but it cannot reduce the incidence of pain.

In a 2019 survey about pregnancy-related pain, 47% of pregnant women reported having lower back pain during pregnancy. The study found that the fewer times women exercised per week before pregnancy, the more likely they were to experience lower back pain during pregnancy.

However, most current exercise intervention studies for pregnancy-related pelvic girdle pain focus on aerobic exercise rather than weight training. Weight training for pregnant women has not yet been widely accepted, and there are many misconceptions. However, meta-analysis of literature shows that weight training during pregnancy does not increase the risk of preterm birth or miscarriage. Moderate-intensity weight training under guidance does not harm maternal or fetal health, and its safety is sufficient. Therefore, we want to understand whether weight training, as opposed to traditional aerobic exercises, can improve pregnancy-related pelvic girdle pain. Are there differences in muscle cell proliferation and differentiation during pregnancy compared to non-pregnant adults? Does incomplete muscle cell differentiation affect muscle strength, leading to pain in pregnant women? And what mechanisms do weight training exercises use to improve pain?

Being tested
weight training
Keywords
pregnancy-related pelvic girdle pain, weight training, resistance training
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.

  • weight trainingBehavioural

    Pregnant women assigned to the intervention group will receive online weight training sessions twice a week, for 60 minutes per session, from the 16th to the 36th week of pregnancy. The Pelvic Girdle Questionnaire will be used to assess the condition of pelvic girdle pain during pregnancy, and to analyze whether weight training can improve this problem. Pelvic floor muscle structure will also be analyzed by pelvic ultrasound to determine whether it has been altered by weight training, leading to an improvement in pain.

Study groups in NCT05879575
Study groupRoleWhat they receive
intervention groupExperimentalreceive weight training during 16-36 gestational weeks and observe pain condition
Receives: Behavioral: weight training
control groupNo interventionobserve pain condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PGQ score

    The main evaluation indicators will include the PGQ activity assessment to evaluate the impact of pelvic girdle pain on daily life, and the PGQ symptom assessment to evaluate the severity of symptoms. These indicators will be used to assess whether weight training during pregnancy improves pelvic girdle pain.

    Measured: change of the PGQ score between the first trimester (before GA 14 weeks) and the third trimester before delivery (GA 35 to 36+6 weeks)

Secondary outcomes (3)
  1. Cervical length

    To evaluate whether exercise during pregnancy may shorten the cervical length.

    Measured: difference of the cervical length between the first trimester (before GA 14 weeks) and the third trimester (GA 35 to 36+6 weeks) of the pregnancy

  2. Duration of the first stage of labor

    To evaluate whether exercise during pregnancy may effect the duration of the first stage of labor

    Measured: During labor

  3. Duration of the second stage of labor

    To evaluate whether exercise during pregnancy may effect the duration of the second stage of labor

    Measured: During labor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start31 May 2023 (estimated)
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

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
intervention group: receive weigh training during 16-36 gestational weeks
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879575
Sponsor's protocol ID
111-152-F
Status last verified
Jun 2023
First submitted
1 Mar 2023
Last updated
6 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.

    PubMed 32217980
  • Bentzinger CF, Wang YX, Rudnicki MA. Building muscle: molecular regulation of myogenesis. Cold Spring Harb Perspect Biol. 2012 Feb 1;4(2):a008342. doi: 10.1101/cshperspect.a008342.

    PubMed 22300977
  • Brightwell CR, Latham CM, Thomas NT, Keeble AR, Murach KA, Fry CS. A glitch in the matrix: the pivotal role for extracellular matrix remodeling during muscle hypertrophy. Am J Physiol Cell Physiol. 2022 Sep 1;323(3):C763-C771. doi: 10.1152/ajpcell.00200.2022. Epub 2022 Jul 25.

    PubMed 35876284
  • Crespi EJ, Steckler TL, Mohankumar PS, Padmanabhan V. Prenatal exposure to excess testosterone modifies the developmental trajectory of the insulin-like growth factor system in female sheep. J Physiol. 2006 Apr 1;572(Pt 1):119-30. doi: 10.1113/jphysiol.2005.103929. Epub 2006 Feb 16.

    PubMed 16484301
  • Gharahdaghi N, Phillips BE, Szewczyk NJ, Smith K, Wilkinson DJ, Atherton PJ. Links Between Testosterone, Oestrogen, and the Growth Hormone/Insulin-Like Growth Factor Axis and Resistance Exercise Muscle Adaptations. Front Physiol. 2021 Jan 15;11:621226. doi: 10.3389/fphys.2020.621226. eCollection 2020.

    PubMed 33519525
  • Gonzalez ML, Busse NI, Waits CM, Johnson SE. Satellite cells and their regulation in livestock. J Anim Sci. 2020 May 1;98(5):skaa081. doi: 10.1093/jas/skaa081.

    PubMed 32175577
  • Lesnak JB, Fahrion A, Helton A, Rasmussen L, Andrew M, Cunard S, Huey M, Kreber A, Landon J, Siwiec T, Todd K, Frey-Law LA, Sluka KA. Resistance training protects against muscle pain through activation of androgen receptors in male and female mice. Pain. 2022 Oct 1;163(10):1879-1891. doi: 10.1097/j.pain.0000000000002638. Epub 2022 Mar 24.

    PubMed 35353765
  • Ringeval M, Wagner G, Denford J, Pare G, Kitsiou S. Fitbit-Based Interventions for Healthy Lifestyle Outcomes: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Oct 12;22(10):e23954. doi: 10.2196/23954.

    PubMed 33044175
  • Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.

    PubMed 18259783
  • Cong H, Liu H, Sun Y, Gao J, Liu J, Ma L, Stuge B, Chen L. Cross-cultural adaptation, reliability, and validity of a Chinese version of the pelvic girdle questionnaire. BMC Pregnancy Childbirth. 2021 Jun 30;21(1):470. doi: 10.1186/s12884-021-03962-8.

    PubMed 34193061
  • Davenport MH, Marchand AA, Mottola MF, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Sobierajski F, James M, Meah VL, Skow RJ, Riske L, Nuspl M, Nagpal TS, Courbalay A, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):90-98. doi: 10.1136/bjsports-2018-099400. Epub 2018 Oct 18.

    PubMed 30337344
  • Dietz HP. Ultrasound imaging of maternal birth trauma. Int Urogynecol J. 2021 Jul;32(7):1953-1962. doi: 10.1007/s00192-020-04669-8. Epub 2021 Feb 17.

    PubMed 33595672
  • Dietz HP, Shek KL. Tomographic ultrasound imaging of the pelvic floor: which levels matter most? Ultrasound Obstet Gynecol. 2009 Jun;33(6):698-703. doi: 10.1002/uog.6403.

    PubMed 19434620
  • Fagevik Olsen M, Elden H, Gutke A. Evaluation of self-administered tests for pelvic girdle pain in pregnancy. BMC Musculoskelet Disord. 2014 Apr 27;15:138. doi: 10.1186/1471-2474-15-138.

    PubMed 24767628
  • Fagevik Olsen M, Kornung P, Kallin S, Elden H, Kjellby Wendt G, Gutke A. Validation of self-administered tests for screening for chronic pregnancy-related pelvic girdle pain. BMC Musculoskelet Disord. 2021 Mar 1;22(1):237. doi: 10.1186/s12891-021-04103-0.

    PubMed 33648489

Questions about this trial

What is this clinical trial studying?

A study testing weight training in people with Pelvic Girdle Pain, run by National Taiwan University Hospital Hsin-Chu Branch 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact KUAN YING HUANG (+886972653739, G01356@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PGQ score (time frame: change of the PGQ score between the first trimester (before GA 14 weeks) and the third trimester before delivery (GA 35 to 36+6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879575, which also lists 24 linked publications.

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 Jun 2023.

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