NCT05879575

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

March 1, 2023

Last Update Submit

June 4, 2023

Conditions

Keywords

pregnancy-related pelvic girdle painweight trainingresistance training

Outcome Measures

Primary Outcomes (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.

    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)

  • Cervical length

    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

  • Duration of the first stage of labor

    During labor

  • Duration of the second stage of labor

    During labor

Study Arms (2)

intervention group

EXPERIMENTAL

receive weight training during 16-36 gestational weeks and observe pain condition

Behavioral: weight training

control group

NO INTERVENTION

observe pain condition

Interventions

weight trainingBEHAVIORAL

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.

intervention group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (24)

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    PMID: 32217980BACKGROUND
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  • 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.

    PMID: 35876284BACKGROUND
  • 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.

    PMID: 16484301BACKGROUND
  • 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.

    PMID: 33519525BACKGROUND
  • 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.

    PMID: 32175577BACKGROUND
  • 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.

    PMID: 35353765BACKGROUND
  • 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.

    PMID: 33044175BACKGROUND
  • 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.

    PMID: 18259783BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Ferreira CW, Alburquerque-Sendi N F. Effectiveness of physical therapy for pregnancy-related low back and/or pelvic pain after delivery: a systematic review. Physiother Theory Pract. 2013 Aug;29(6):419-31. doi: 10.3109/09593985.2012.748114. Epub 2012 Dec 17.

  • Marin-Jimenez N, Acosta-Manzano P, Borges-Cosic M, Baena-Garcia L, Coll-Risco I, Romero-Gallardo L, Aparicio VA. Association of self-reported physical fitness with pain during pregnancy: The GESTAFIT Project. Scand J Med Sci Sports. 2019 Jul;29(7):1022-1030. doi: 10.1111/sms.13426. Epub 2019 Apr 29.

  • O'Connor PJ, Poudevigne MS, Cress ME, Motl RW, Clapp JF 3rd. Safety and efficacy of supervised strength training adopted in pregnancy. J Phys Act Health. 2011 Mar;8(3):309-20. doi: 10.1123/jpah.8.3.309.

  • Perales M, Santos-Lozano A, Ruiz JR, Lucia A, Barakat R. Benefits of aerobic or resistance training during pregnancy on maternal health and perinatal outcomes: A systematic review. Early Hum Dev. 2016 Mar;94:43-8. doi: 10.1016/j.earlhumdev.2016.01.004. Epub 2016 Feb 3.

  • Petrov Fieril K, Glantz A, Fagevik Olsen M. The efficacy of moderate-to-vigorous resistance exercise during pregnancy: a randomized controlled trial. Acta Obstet Gynecol Scand. 2015 Jan;94(1):35-42. doi: 10.1111/aogs.12525. Epub 2014 Nov 13.

  • Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196.

  • Stuge B, Jenssen HK, Grotle M. The Pelvic Girdle Questionnaire: Responsiveness and Minimal Important Change in Women With Pregnancy-Related Pelvic Girdle Pain, Low Back Pain, or Both. Phys Ther. 2017 Nov 1;97(11):1103-1113. doi: 10.1093/ptj/pzx078.

  • Welch N, Moran K, Antony J, Richter C, Marshall B, Coyle J, Falvey E, Franklyn-Miller A. The effects of a free-weight-based resistance training intervention on pain, squat biomechanics and MRI-defined lumbar fat infiltration and functional cross-sectional area in those with chronic low back. BMJ Open Sport Exerc Med. 2015 Nov 9;1(1):e000050. doi: 10.1136/bmjsem-2015-000050. eCollection 2015.

  • Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27.

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hung-Yuan Li

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

KUAN YING HUANG

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention group: receive weigh training during 16-36 gestational weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

May 30, 2023

Study Start

May 31, 2023

Primary Completion

March 31, 2024

Study Completion

October 1, 2024

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations