Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health (ASK)
1 settembre 2026 aggiornato da: LAI KWAN LAM, Chinese University of Hong Kong
Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health: a Pilot Randomized Controlled 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: LAI KWAN LAM, PhD
- Numero di telefono: +85235054267
- Email: laikwanlam@cuhk.edu.hk
Luoghi di studio
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong
- The Department of Obstetrics and Gynaecology, The Chinese University Of Hong Kong
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Contatto:
- YAO WANG, PhD
- Numero di telefono: +85235051289
- Email: yaowang1@cuhk.edu.hk
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Recruitment rate to the ASK Exercise Programme
Lasso di tempo: From recruitment initiation to 12 weeks
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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.
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From recruitment initiation to 12 weeks
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Retention rate in the ASK Exercise Programme
Lasso di tempo: 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.
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From baseline to 12 weeks
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Dropout rate from the ASK Exercise Programme
Lasso di tempo: From baseline to 12 weeks
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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.
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From baseline to 12 weeks
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Assessment completion in the ASK Exercise Programme
Lasso di tempo: From baseline to 12 weeks
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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.
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From baseline to 12 weeks
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Participant satisfaction rate
Lasso di tempo: At 12 weeks
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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.
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At 12 weeks
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ASK session completion rate
Lasso di tempo: Throughout the 12-week intervention period
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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.
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Throughout the 12-week intervention period
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Adverse events related to the ASK Exercise Programme
Lasso di tempo: Throughout the 12-week intervention period
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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.
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Throughout the 12-week intervention period
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Postpartum recovery score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Postnatal depressive symptom score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Pelvic floor symptom distress score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Sleep quality score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Breastfeeding self-efficacy score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Health-related quality of life score
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Body mass index
Lasso di tempo: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
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Waist-hip ratio
Lasso di tempo: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
|
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Resting heart rate
Lasso di tempo: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
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Systolic blood pressure
Lasso di tempo: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
|
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Diastolic blood pressure
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
|
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Fasting glucose concentration
Lasso di tempo: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
|
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HbA1c
Lasso di tempo: Baseline and 12 weeks
|
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.
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Baseline and 12 weeks
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Triglyceride concentration
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Total cholesterol concentration
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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High-density lipoprotein cholesterol concentration
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Low-density lipoprotein cholesterol concentration
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Post-exercise recovery heart rate
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Daily step count
Lasso di tempo: Throughout the 12-week intervention period
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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.
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Throughout the 12-week intervention period
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Daily active minutes
Lasso di tempo: Throughout the 12-week intervention period
|
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.
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Throughout the 12-week intervention period
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Exploratory gut microbiome profile
Lasso di tempo: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Yao Wang, PhD, Chinese University of Hong Kong
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 dicembre 2026
Completamento primario (Stimato)
30 novembre 2029
Completamento dello studio (Stimato)
30 novembre 2029
Date di iscrizione allo studio
Primo inviato
28 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 agosto 2026
Primo Inserito (Effettivo)
27 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CREC Ref. No.:2026.436
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .