NCT06560190

Brief Summary

Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their career advancement. While there is epidemiological data across multiple branches of service, there is a gap in the literature in terms of how to appropriately address these decreased fitness levels and better understand the root causes. American College of Gynecology (ACOG) recommends that the postpartum visit include actionable information on return to physical activity. However, a large majority of women report receiving no guidance on how to engage in physical activity during pregnancy and in the postpartum period. Physical therapy is commonly used to help individuals return to physical activity following orthopaedic surgeries, but it is not frequently utilized to assist the postpartum population in progressing back to physical activity. Orthopaedic Manual Physical Therapists (OMPTs) are uniquely trained to address musculoskeletal symptoms and progress physical activity. An OMPT evaluation and treatment could facilitate increased physical activity and improve health-related quality of life, supporting the ACOG recommendation to make postpartum care an ongoing multidisciplinary process.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 8, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2025

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 15, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

PostpartumPhysical ActivityPregnancyService MemberPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • 36-Item Short Form Survey Instrument (SF36)

    The 36-Item Short Form Survey Instrument (SF 36) is the most widely used quality of life tool in the postpartum population. The lowest score on each subscale is zero and the highest score on each subscale is 100. A higher score is better.

    Baseline, 4 weeks and 8 weeks

Secondary Outcomes (4)

  • International Physical Activity Questionnaire- Short Form (IPAQ)

    Baseline, 4 weeks and 8 weeks

  • Numeric Pain Rating Scale (NPRS)

    Baseline, 4 weeks and 8 weeks

  • Cozean Pelvic Dysfunction Screening Protocol

    Baseline, 4 weeks and 8 weeks

  • Edinburgh Postnatal Depression Scale (EPDS)

    Baseline

Study Arms (1)

Postpartum Study Participant

EXPERIMENTAL

Pragmatic Orthopaedic Physical Therapy

Other: Orthopaedic Manual Physical Therapy

Interventions

Individualized Treatment

Postpartum Study Participant

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female Active-Duty Service Member
  • Postpartum \>6 weeks and \<6 months
  • Cleared by OBGYN at postpartum follow-up to initiate physical activity

You may not qualify if:

  • Current or ongoing treatment by an orthopaedic physical therapist
  • Separating from military service in the next 6 months
  • Current permanent profile for a musculoskeletal condition
  • Peripartum Hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Related Publications (9)

  • Iobst SE, Smith DC, Best NI, Allard RJ, Trego LL. A Scoping Review of Pregnancy, Childbirth, and the Postpartum Period in Active Duty U.S. Military Women. Womens Health Issues. 2021 Aug 25;31 Suppl 1:S81-S92. doi: 10.1016/j.whi.2020.05.005.

    PMID: 34454706BACKGROUND
  • Miller MJ, Kutcher J, Adams KL. Effect of Pregnancy on Performance of a Standardized Physical Fitness Test. Mil Med. 2017 Nov;182(11):e1859-e1863. doi: 10.7205/MILMED-D-17-00093.

    PMID: 29087853BACKGROUND
  • Weina SU. Effects of pregnancy on the Army Physical Fitness Test. Mil Med. 2006 Jun;171(6):534-7. doi: 10.7205/milmed.171.6.534.

    PMID: 16808137BACKGROUND
  • DeGroot DW, Sitler CA, Lustik MB, Langan KL, Hauret KG, Gotschall MH, Gehrich AP. The effect of pregnancy and the duration of postpartum convalescence on the physical fitness of healthy women: A cohort study of active duty servicewomen receiving 6 weeks versus 12 weeks convalescence. PLoS One. 2021 Jul 28;16(7):e0255248. doi: 10.1371/journal.pone.0255248. eCollection 2021.

    PMID: 34320030BACKGROUND
  • Armitage NH, Smart DA. Changes in Air Force fitness measurements pre- and post-childbirth. Mil Med. 2012 Dec;177(12):1519-23. doi: 10.7205/milmed-d-12-00248.

    PMID: 23397699BACKGROUND
  • ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

    PMID: 29683911BACKGROUND
  • Doran F, Davis K. Factors that influence physical activity for pregnant and postpartum women and implications for primary care. Aust J Prim Health. 2011;17(1):79-85. doi: 10.1071/PY10036.

    PMID: 21616029BACKGROUND
  • Selman R, Early K, Battles B, Seidenburg M, Wendel E, Westerlund S. Maximizing Recovery in the Postpartum Period: A Timeline for Rehabilitation from Pregnancy through Return to Sport. Int J Sports Phys Ther. 2022 Oct 1;17(6):1170-1183. doi: 10.26603/001c.37863. eCollection 2022.

    PMID: 36237644BACKGROUND
  • Christopher, S.M., et al., Rehabilitation of the Postpartum Runner: A 4-Phase Approach. Journal of Women's Health Physical Therapy, 2022. 46(2): p. 73-86.

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Casey Shutt-Hoblet, DPT

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MAJ Casey Shutt-Hoblet, PT, DPT

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

April 8, 2024

Primary Completion

July 5, 2025

Study Completion

July 5, 2025

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations