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

1. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • The Department of Obstetrics and Gynaecology, The Chinese University Of Hong Kong
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: ASK Exercise Programme
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment rate to the ASK Exercise Programme
Tidsramme: 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.
From recruitment initiation to 12 weeks
Retention rate in the ASK Exercise Programme
Tidsramme: 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.
From baseline to 12 weeks
Dropout rate from the ASK Exercise Programme
Tidsramme: 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.
From baseline to 12 weeks
Assessment completion in the ASK Exercise Programme
Tidsramme: 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.
From baseline to 12 weeks
Participant satisfaction rate
Tidsramme: 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.
At 12 weeks
ASK session completion rate
Tidsramme: 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.
Throughout the 12-week intervention period
Adverse events related to the ASK Exercise Programme
Tidsramme: 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.
Throughout the 12-week intervention period
Postpartum recovery score
Tidsramme: 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.
Baseline and 12 weeks
Postnatal depressive symptom score
Tidsramme: 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.
Baseline and 12 weeks
Pelvic floor symptom distress score
Tidsramme: 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.
Baseline and 12 weeks
Sleep quality score
Tidsramme: 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.
Baseline and 12 weeks
Breastfeeding self-efficacy score
Tidsramme: 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.
Baseline and 12 weeks
Health-related quality of life score
Tidsramme: 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.
Baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body mass index
Tidsramme: 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
Waist-hip ratio
Tidsramme: 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.
Baseline and 12 weeks
Resting heart rate
Tidsramme: 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.
Baseline and 12 weeks
Systolic blood pressure
Tidsramme: 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.
Baseline and 12 weeks
Diastolic blood pressure
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
Fasting glucose concentration
Tidsramme: 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.
Baseline and 12 weeks
HbA1c
Tidsramme: 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.
Baseline and 12 weeks
Triglyceride concentration
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
Total cholesterol concentration
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
High-density lipoprotein cholesterol concentration
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
Low-density lipoprotein cholesterol concentration
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
Post-exercise recovery heart rate
Tidsramme: Baseline and 12 weeks
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.
Baseline and 12 weeks
Daily step count
Tidsramme: Throughout the 12-week intervention period
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.
Throughout the 12-week intervention period
Daily active minutes
Tidsramme: 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.
Throughout the 12-week intervention period
Exploratory gut microbiome profile
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chinese University of Hong Kong

Etterforskere

  • Hovedetterforsker: Yao Wang, PhD, Chinese University of Hong Kong

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

30. november 2029

Studiet fullført (Antatt)

30. november 2029

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CREC Ref. No.:2026.436

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