Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health

NCT07790289 | Not Yet Recruiting

• 1 other identifier: NTEC-2026-456
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to learn whether a 12-week home-based exercise programme is feasible, acceptable, and safe for postpartum women in Hong Kong who had hypertensive disorders of pregnancy. The exercise programme is called the Aerobic, Strength, and Kegel exercise programme, or ASK programme. The main questions this study aims to answer are:

• Can postpartum women follow the ASK exercise programme at home?
• Is the ASK exercise programme acceptable and safe?
• Does the ASK exercise programme show early benefits for postpartum recovery and health? Researchers will compare women who receive the ASK exercise programme with women who receive standard postnatal care. Participants will be randomly assigned to one of the two groups. They will complete study assessments at the beginning of the study and after 12 weeks. Women in the ASK exercise programme group will complete three 60-minute exercise sessions per week for 12 weeks, supported by a mobile app and wearable device. Women in the standard postnatal care group will continue to receive usual postnatal care.

Conditions

Quality of Life; Body Composition; Sleep; Physical Abilities; Cardiometabolic Health; Postpartum Health

Keywords

Postpartum health; Postpartum exercise; Pelvic floor muscle training; Cardiometabolic health; Pilot randomized controlled trial

Outcome Measures

Primary Outcomes (13)

• Recruitment rate to the ASK Exercise Programme

  Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible participants approached. The outcome will be reported as a percentage of eligible participants approached.

  From recruitment initiation to 12 weeks

• Retention rate in the ASK Exercise Programme

  Retention rate will be calculated as the number of enrolled participants who complete the 12-week follow-up assessment divided by the total number of enrolled participants. The outcome will be reported as a percentage of enrolled participants.

  From baseline to 12 weeks

• Dropout rate from the ASK Exercise Programme

  Dropout rate will be calculated as the number of participants who withdraw or are lost to follow-up before the 12-week assessment divided by the total number of enrolled participants. The outcome will be reported as a percentage of enrolled participants.

  From baseline to 12 weeks

• Assessment completion in the ASK Exercise Programme

  Assessment completion rate will be calculated as the number of completed planned study assessments divided by the total number of planned study assessments. The outcome will be reported as a percentage of planned study assessments.

  From baseline to 12 weeks

• Participant satisfaction rate

  Participant satisfaction will be assessed using a study-specific acceptability questionnaire administered at 12 weeks. Satisfaction will be defined as reporting "satisfied" or "very satisfied" with the ASK Exercise Programme. The outcome will be reported as the percentage of participants who are satisfied or very satisfied.

  At 12 weeks

• ASK session completion rate

  ASK session completion rate will be calculated as the number of prescribed ASK exercise sessions completed divided by the total number of prescribed ASK exercise sessions during the 12-week intervention period. Session completion will be assessed using app-recorded exercise completion data. The outcome will be reported as a percentage of prescribed ASK exercise sessions.

  Throughout the 12-week intervention period

• Adverse events related to the ASK Exercise Programme

  Safety will be assessed as the number of participants who experience one or more adverse events related to the ASK Exercise Programme during the 12-week intervention period. Adverse events and exercise-related symptoms will be collected using participant symptom reports and study adverse event records. The outcome will be reported as the number of participants with adverse events related to the ASK Exercise Programme.

  Throughout the 12-week intervention period

• Postpartum recovery score

  Postpartum recovery will be assessed using the Obstetric Quality of Recovery-10. The change from baseline to 12 weeks in the total Obstetric Quality of Recovery-10 score will be calculated. Total scores range from 0 to 100, with higher scores indicating better postpartum recovery.

  Baseline and 12 weeks

• Postnatal depressive symptom score

  Postnatal depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale. The change from baseline to 12 weeks in the total Edinburgh Postnatal Depression Scale score will be calculated. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.

  Baseline and 12 weeks

• Pelvic floor symptom distress score

  Pelvic floor symptom distress will be assessed using the Pelvic Floor Distress Inventory-20. The change from baseline to 12 weeks in the total Pelvic Floor Distress Inventory-20 score will be calculated. Total scores range from 0 to 300, with higher scores indicating greater pelvic floor symptom distress.

  Baseline and 12 weeks

• Sleep quality score

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The change from baseline to 12 weeks in the global Pittsburgh Sleep Quality Index score will be calculated. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.

  Baseline and 12 weeks

• Breastfeeding self-efficacy score

  Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form. The change from baseline to 12 weeks in the total Breastfeeding Self-Efficacy Scale-Short Form score will be calculated. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.

  Baseline and 12 weeks

• Health-related quality of life score

  Health-related quality of life will be assessed using the Short Form-12 Health Survey. The change from baseline to 12 weeks in the health-related quality of life score will be calculated. The outcome will be reported as a score on a scale, with higher scores indicating better health-related quality of life.

  Baseline and 12 weeks

Secondary Outcomes (15)

• Body mass index

  Baseline and 12 weeks

• Waist-hip ratio

  Baseline and 12 weeks

• Resting heart rate

  Baseline and 12 weeks

• Systolic blood pressure

  Baseline and 12 weeks

• Diastolic blood pressure

  Baseline and 12 weeks

Study Arms (2)

ASK Exercise Programme

EXPERIMENTAL

Participants assigned to this arm will receive the Aerobic, Strength, and Kegel exercise programme (ASK programme) in addition to standard postnatal care. The ASK programme is a 12-week home-based, app-guided exercise intervention supported by a wearable device. Participants will be asked to complete three exercise sessions per week, with each session lasting approximately 60 minutes. The programme includes aerobic exercise, strength training, and Kegel-based pelvic floor muscle training.

Other: ASK Exercise Programme

Standard Postnatal Care

NO INTERVENTION

Participants allocated to the control group will receive standard postnatal care, including routine postpartum follow-up and general health advice. They will not receive the ASK programme during the 12-week study period. They will complete the same baseline and post-intervention assessments as participants in the intervention group.

Interventions

ASK Exercise Programme OTHER

The ASK Exercise Programme is a 12-week home-based, app-guided exercise intervention supported by a wearable device. Participants will be asked to complete three sessions per week, with each session lasting approximately 60 minutes. The programme includes aerobic exercise, strength training, and Kegel-based pelvic floor muscle training. The mobile app and wearable device will be used to support exercise delivery, self-monitoring, and adherence tracking.

ASK Exercise Programme

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility is limited to postpartum women because the study focuses on postpartum recovery after childbirth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female Asian postpartum women aged 18 to 45 years
• Singleton pregnancy
• to 8 weeks postpartum at the time of enrolment
• Medically stable after childbirth
• Physically able to participate in low-to-moderate intensity exercise training
• Able and willing to participate in the 12-week study programme
• Able to use the study app and wearable device, or willing to receive instruction on their use
• Able to provide written informed consent

You may not qualify if:

• Multiple pregnancy
• Severe postpartum medical complications or conditions contraindicating exercise participation
• Severe cardiovascular, respiratory, neurological, or major musculoskeletal conditions that may limit safe participation in exercise
• Current use of medication likely to substantially affect cardiac function, including heart failure therapy
• Antibiotic treatment within the preceding month
• Severe mental illness or other condition affecting the ability to provide informed consent or comply with study procedures
• Any medical, obstetric, or psychological condition judged by the research team or attending clinician to make participation unsafe or inappropriate
• Inability or unwillingness to adhere to the 12-week ASK programme or study assessments

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Department of Obstetrics and Gynaecology, The Chinese University Of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

Study Officials

• Yao Wang, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAI KWAN LAM, PhD

CONTACT

+85291844948; laikwanlam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)