Postpartum Physical Fitness and Functional PerformanceNCT07867275
Strong as a Mother
A study testing Supervised Postpartum Functional Strength Training and Aerobic Conditioning in people with Postpartum Physical Fitness and Functional Performance, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Physical Fitness and Functional Performance
- What is being tested?
- Supervised Postpartum Functional Strength Training and Aerobic Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2027to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
Janette Watkins, PhD, 502-321-9683, jjw7102@psu.edu
About this study
Official title: Strong as a Mother: A Pilot Study of Community-Based Strength and Conditioning to Support Postpartum Physical Capacity and Functional Performance
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.
Read the detailed description
The study addresses the transition between postpartum medical clearance and participation in progressive community exercise. It will evaluate an existing program that combines functional resistance training and aerobic conditioning with breathing and bracing instruction. Strength exercises include squat, hinge, push, pull, and carry movements relevant to daily physical demands. A Certified Strength and Conditioning Specialist with specialized pregnancy and postpartum training will individualize exercise selection and progression according to symptoms, training experience, technique, and current capacity.
The RE-AIM framework will guide evaluation of recruitment and participant characteristics, program implementation, and resources needed for future delivery. Session records will document exercise dose, progression, modifications, symptoms, and adverse events. Participant feedback will help identify barriers to attendance, assessment burden, and opportunities to improve the program. Adoption and future sustainment requirements will be described through the established community partnership; long-term maintenance will not be evaluated.
The study will also explore whether changes in physiological capacity correspond with changes in lifting, carrying, chair-rise performance, and perceived maternal functioning. Abdominal-wall ultrasound will provide complementary information about morphology and behavior during a standardized contraction; inter-recti distance alone will not be interpreted as abdominal-wall function.
Analyses will emphasize feasibility estimates, baseline-adjusted between-group differences, confidence intervals, outcome variability, and assessment completion. The pilot is not designed to establish definitive effectiveness or test causal mechanisms. Findings will inform program refinement, selection of a primary outcome, and design of a larger trial.
- Being tested
- Supervised Postpartum Functional Strength Training and Aerobic Conditioning
- Keywords
- Postpartum exercise, Maternal physical function, Community-based exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Postpartum Functional Strength Training and Aerobic ConditioningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: At completion of the 12-week intervention
Secondary outcomes (4)
Change in Peak Oxygen Uptake (VO₂peak)
Peak oxygen uptake measured using the PNOĒ metabolic analyzer during a standardized graded cycle test, expressed in mL/kg/min. Higher values indicate greater cardiorespiratory fitness.
Measured: Baseline and 12 weeks
Change in Grip Strength
Handgrip strength measured using a dynamometer under standardized testing conditions, expressed in kilograms. Higher values indicate greater grip strength.
Measured: Baseline and 12 weeks
Change in Five-Repetition Maximum Deadlift Load
Greatest load, in kilograms, lifted for five repetitions while meeting prespecified technique and symptom-tolerance criteria. Higher loads indicate greater lifting strength.
Measured: Baseline and 12 weeks
Change in Five-Times Sit-to-Stand Completion Time
Time, in seconds, required to complete five chair rises using standardized chair height, arm position, and instructions. Shorter times indicate better performance.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 May 2027 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Physical Fitness and Functional PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janette Watkins, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867275
- Sponsor's protocol ID
- STUDY00030260
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong as a Mother: A Pilot Study of Community-Based Strength and Conditioning to Support Postpartum Physical Capacity and Functional Performance
- ClinicalTrials.gov ID
- NCT07867275
- Acronym / sponsor ID
- STUDY00030260
- Keywords
- Postpartum exercise, Maternal physical function, Community-based exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study addresses the transition between postpartum medical clearance and participation in progressive community exercise. It will evaluate an existing program that combines functional resistance training and aerobic conditioning with breathing and bracing instruction. Strength exercises include squat, hinge, push, pull, and carry movements relevant to daily physical demands. A Certified Strength and Conditioning Specialist with specialized pregnancy and postpartum training will individualize exercise selection and progression according to symptoms, training experience, technique, and current capacity.
The RE-AIM framework will guide evaluation of recruitment and participant characteristics, program implementation, and resources needed for future delivery. Session records will document exercise dose, progression, modifications, symptoms, and adverse events. Participant feedback will help identify barriers to attendance, assessment burden, and opportunities to improve the program. Adoption and future sustainment requirements will be described through the established community partnership; long-term maintenance will not be evaluated.
The study will also explore whether changes in physiological capacity correspond with changes in lifting, carrying, chair-rise performance, and perceived maternal functioning. Abdominal-wall ultrasound will provide complementary information about morphology and behavior during a standardized contraction; inter-recti distance alone will not be interpreted as abdominal-wall function.
Analyses will emphasize feasibility estimates, baseline-adjusted between-group differences, confidence intervals, outcome variability, and assessment completion. The pilot is not designed to establish definitive effectiveness or test causal mechanisms. Findings will inform program refinement, selection of a primary outcome, and design of a larger trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Postpartum Exercise Program | Experimental | Behavioral: Supervised Postpartum Functional Strength Training and Aerobic ConditioningParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Postpartum Functional Strength Training and Aerobic ConditioningA 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. | Behavioural | Immediate Postpartum Exercise Program |
Primary outcome
Intervention Attendance
Time frame: During the 12-week intervention
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%.
Recruitment: Number of Participants Enrolled
Time frame: From recruitment initiation through recruitment closure
Number of eligible, consenting women randomized, with a target of 30 participants. Numbers screened and eligible and reasons for nonparticipation will also be recorded.
Perceived Program Feasibility
Time frame: At completion of the 12-week intervention
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.
4 secondary outcomes
Change in Peak Oxygen Uptake (VO₂peak)
Time frame: Baseline and 12 weeks
Change in Grip Strength
Time frame: Baseline and 12 weeks
Change in Five-Repetition Maximum Deadlift Load
Time frame: Baseline and 12 weeks
Change in Five-Times Sit-to-Stand Completion Time
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Postpartum Functional Strength Training and Aerobic Conditioning in people with Postpartum Physical Fitness and Functional Performance, run by Penn State University at 1 site in United States.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Watkins, PhD (5023219683, jjw7102@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Attendance (time frame: During the 12-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.