About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female Asian postpartum women aged 18 to 45 years
Singleton pregnancy
6 to 8 weeks postpartum at the time of enrolment
Medically stable after childbirth
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
ASK Exercise Programme
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Body mass index
Body mass index will be calculated as body weight in kilograms divided by height in meters squared. The change from baseline to 12 weeks in body mass index will be calculated. The outcome will be reported in kg/m².
Waist-hip ratio
Waist-hip ratio will be calculated as waist circumference divided by hip circumference. The change from baseline to 12 weeks in waist-hip ratio will be calculated. The outcome will be reported as a ratio.
Resting heart rate
Resting heart rate will be measured at baseline and 12 weeks. The change from baseline to 12 weeks in resting heart rate will be calculated. The outcome will be reported in beats per minute.
Systolic blood pressure
Systolic blood pressure will be measured at baseline and 12 weeks where available through home or routine clinical measurement. The change from baseline to 12 weeks in systolic blood pressure will be calculated. The outcome will be reported in mmHg.
Sponsors and contacts
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