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.
This is a parallel-group pilot randomized controlled trial designed to evaluate the feasibility, acceptability, safety, and preliminary effectiveness of the ASK Programme, a 12-week home-based postpartum exercise intervention for Asian women in Hong Kong. The ASK Programme combines aerobic training, strength training, and Kegel-based pelvic floor muscle training, and is delivered through a study app with wearable-supported monitoring. Eligible participants will be enrolled at 6 to 8 weeks postpartum and randomized in a 1:1 ratio to either the ASK Programme intervention group or the standard postnatal care control group. Participants in the intervention group will complete three home-based ASK exercise sessions per week for 12 weeks. Each session will include warm-up, aerobic training, strength training, pelvic floor muscle training, and cool-down. The control group will receive standard postnatal care. Assessments will be conducted at baseline and within 1 week after completion of the 12-week intervention. The study will collect feasibility, adherence, safety, acceptability, clinical, behavioral, psychosocial, physiological, cardiometabolic, and exploratory biological data to inform the design of a future full-scale randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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.
The Department of Obstetrics and Gynaecology, The Chinese University Of Hong Kong
Hong Kong, Hong Kong, Hong Kong
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
Diastolic blood pressure
Diastolic 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 diastolic blood pressure will be calculated. The outcome will be reported in mmHg.
Time frame: Baseline and 12 weeks
Fasting glucose concentration
Fasting glucose concentration will be measured using fasting blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in fasting glucose concentration will be calculated. The outcome will be reported in mmol/L.
Time frame: Baseline and 12 weeks
HbA1c
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HbA1c will be measured using blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in HbA1c will be calculated. The outcome will be reported as a percentage.
Time frame: Baseline and 12 weeks
Triglyceride concentration
Triglyceride concentration will be measured using fasting blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in triglyceride concentration will be calculated. The outcome will be reported in mmol/L.
Time frame: Baseline and 12 weeks
Total cholesterol concentration
Total cholesterol concentration will be measured using fasting blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in total cholesterol concentration will be calculated. The outcome will be reported in mmol/L.
Time frame: Baseline and 12 weeks
High-density lipoprotein cholesterol concentration
High-density lipoprotein cholesterol concentration will be measured using fasting blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in high-density lipoprotein cholesterol concentration will be calculated. The outcome will be reported in mmol/L.
Time frame: Baseline and 12 weeks
Low-density lipoprotein cholesterol concentration
Low-density lipoprotein cholesterol concentration will be measured using fasting blood samples at baseline and 12 weeks. The change from baseline to 12 weeks in low-density lipoprotein cholesterol concentration will be calculated. The outcome will be reported in mmol/L.
Time frame: Baseline and 12 weeks
Post-exercise recovery heart rate
Cardiorespiratory fitness will be assessed using a 3-minute step test. Post-exercise recovery heart rate will be recorded after completion of the test. The change from baseline to 12 weeks in post-exercise recovery heart rate will be calculated. The outcome will be reported in beats per minute.
Time frame: Baseline and 12 weeks
Daily step count
Daily step count will be recorded using wearable-derived activity data. Mean daily step count during the 12-week intervention period will be calculated. The outcome will be reported as steps per day.
Time frame: Throughout the 12-week intervention period
Daily active minutes
Daily active minutes will be recorded using wearable-derived activity data. Mean daily active minutes during the 12-week intervention period will be calculated. The outcome will be reported as minutes per day.
Time frame: Throughout the 12-week intervention period
Exploratory gut microbiome profile
Gut microbiome profiles will be assessed using stool samples collected at baseline and 12 weeks. Changes from baseline to 12 weeks in gut microbiome profiles will be explored, including microbial diversity and taxonomic composition, depending on sample availability and sequencing quality.
Time frame: Baseline and 12 weeks