NCT07867275

Brief Summary

This study will evaluate Strong as a Mother, an existing community exercise program for women returning to exercise after childbirth. The goal is to determine whether the program can be delivered consistently, whether participants find it acceptable, and how it may affect fitness and physical function. Approximately 30 medically cleared women who are 3-12 months postpartum will be randomly assigned to begin the program immediately or continue their usual activities for 12 weeks before being offered the program. The program includes three supervised sessions per week combining strength training, aerobic exercise, and breathing and bracing instruction. Exercises will be adjusted to participants' abilities and symptoms. Assessments will occur before and after the 12-week period, with a brief check-in at six weeks. Researchers will measure participation, program delivery, and adverse events, along with aerobic fitness, grip strength, and lifting, carrying, and chair-rise performance. Additional assessments will examine abdominal-wall characteristics, maternal functioning, postpartum quality of life, and pelvic-floor symptoms. This pilot study will provide preliminary findings to refine the program and plan a larger trial.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started May 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

9 days

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Postpartum exerciseMaternal physical functionCommunity-based exercise

Outcome Measures

Primary Outcomes (3)

  • Intervention Attendance

    Mean percentage of 36 scheduled sessions attended across all participants assigned to immediate intervention, including those who discontinue. The progression target is at least 75%.

    During the 12-week intervention

  • Recruitment: Number of Participants Enrolled

    Number of eligible, consenting women randomized, with a target of 30 participants. Numbers screened and eligible and reasons for nonparticipation will also be recorded.

    From recruitment initiation through recruitment closure

  • Perceived Program Feasibility

    Feasibility of Intervention Measure: four items rated from 1 to 5. The mean score ranges from 1 to 5; higher scores indicate greater perceived feasibility.

    At completion of the 12-week intervention

Secondary Outcomes (4)

  • Change in Peak Oxygen Uptake (VO₂peak)

    Baseline and 12 weeks

  • Change in Grip Strength

    Baseline and 12 weeks

  • Change in Five-Repetition Maximum Deadlift Load

    Baseline and 12 weeks

  • Change in Five-Times Sit-to-Stand Completion Time

    Baseline and 12 weeks

Study Arms (2)

Immediate Postpartum Exercise Program

EXPERIMENTAL

Participants will begin Strong as a Mother, a 12-week community-based exercise program comprising three supervised sessions per week. Sessions combine progressive functional strength training, aerobic conditioning, and breathing and bracing instruction. A Certified Strength and Conditioning Specialist with specialized pregnancy and postpartum training will individualize exercises and progression according to symptoms, training experience, technique, and physical capacity.

Behavioral: Supervised Postpartum Functional Strength Training and Aerobic Conditioning

Usual-Activity Waitlist Control

NO INTERVENTION

Participants will continue their usual activities for the initial 12-week comparison period without receiving the study exercise program. Outside exercise and relevant clinical care will be documented. After completing the 12-week assessments, participants will be offered the same Strong as a Mother program.

Interventions

A 12-week community-based exercise program consisting of three supervised sessions per week, for 36 scheduled sessions. Training combines progressive functional resistance exercises-including squat, hinge, push, pull, and carry movements-with aerobic conditioning and pelvic-floor-informed breathing and bracing instruction. A Certified Strength and Conditioning Specialist with specialized pregnancy and postpartum training individualizes exercise selection, resistance loads, conditioning intensity, and progression according to each participant's symptoms, training experience, technique, and physical capacity. Attendance, exercise dose, progression, and modifications are documented throughout the program.

Immediate Postpartum Exercise Program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 years or older.
  • Between 3 and 12 months postpartum at enrollment.
  • Medically cleared to participate in exercise.
  • Able to participate in the exercise program and study assessments.
  • Willing to accept random assignment to immediate intervention or usual-activity waitlist.
  • Able to provide informed consent.

You may not qualify if:

  • Currently pregnant.
  • Medical contraindication to the prescribed exercise or fitness assessments.
  • Unresolved postpartum complications or symptoms requiring clinical evaluation before participation.
  • A condition requiring a level of clinical supervision beyond what the community program can provide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Central Study Contacts

Watkins, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data from this pilot study. Aggregate findings will be disseminated through publications and presentations. Any future data-sharing proposal would require review of participant consent, privacy protections, and institutional requirements.

Locations