Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate to the ASK Exercise Programme
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
ASK Exercise Programme
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.
干预措施: ASK Exercise Programme (Other)
Standard Postnatal Care
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.
结局指标
主要结局
Recruitment rate to the ASK Exercise Programme
时间窗: From recruitment initiation to 12 weeks
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
时间窗: From baseline to 12 weeks
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
时间窗: From baseline to 12 weeks
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
时间窗: From baseline to 12 weeks
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.
Participant satisfaction rate
时间窗: At 12 weeks
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.
ASK session completion rate
时间窗: Throughout the 12-week intervention period
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.
Adverse events related to the ASK Exercise Programme
时间窗: Throughout the 12-week intervention period
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.
Postpartum recovery score
时间窗: Baseline and 12 weeks
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.
Postnatal depressive symptom score
时间窗: Baseline and 12 weeks
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.
Pelvic floor symptom distress score
时间窗: Baseline and 12 weeks
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.
Sleep quality score
时间窗: Baseline and 12 weeks
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.
Breastfeeding self-efficacy score
时间窗: Baseline and 12 weeks
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.
Health-related quality of life score
时间窗: Baseline and 12 weeks
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.
次要结局
- 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)
- Fasting glucose concentration(Baseline and 12 weeks)
- HbA1c(Baseline and 12 weeks)
- Triglyceride concentration(Baseline and 12 weeks)
- Total cholesterol concentration(Baseline and 12 weeks)
- High-density lipoprotein cholesterol concentration(Baseline and 12 weeks)
- Low-density lipoprotein cholesterol concentration(Baseline and 12 weeks)
- Post-exercise recovery heart rate(Baseline and 12 weeks)
- Daily step count(Throughout the 12-week intervention period)
- Daily active minutes(Throughout the 12-week intervention period)
- Exploratory gut microbiome profile(Baseline and 12 weeks)
研究者
LAI KWAN LAM
Postdoctoral Fellow
Chinese University of Hong Kong