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Exercise and Wellbeing: The Effect of Group Exercise on Mental Wellbeing Among Pregnant Women (EWE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833519
First Posted: July 14, 2016
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanne Kristine Hegaard, Rigshospitalet, Denmark
  Purpose

The purpose of this study is to examine the effect of supervised group exercise on mental wellbeing and signs of depression among pregnant women at risk of perinatal depression in a randomized controlled clinical trial.

The investigators hypothesis is that 70 minutes of supervised group exercise twice a week for 12 weeks by pregnant women at risk of perinatal depression, will improve the participants mental wellbeing and reduce their symptoms of depression.


Condition Intervention
Depression Behavioral: group exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Group Exercise on Mental Wellbeing Among Pregnant Women at Risk of Perinatal Depression: A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hanne Kristine Hegaard, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • World Health Organisation Five Well-being Index (WHO-5). [ Time Frame: 29th-34th week of gestation ]
    Psychological well-being will be measured by the World Health Organisation Five Well-being Index (WHO-5) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.


Secondary Outcome Measures:
  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 29th-34th week of gestation and 2 months after delivery ]
    Symptoms of depression measured by Edinburgh Postnatal Depression Scale (EPDS) will be defined as a cutoff score ≥13 and a cutoff score ≥10. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • The 12-item General Health Questionnaire (GHQ-12) [ Time Frame: 29th-34th week of gestation and 2 months after delivery ]
    Functional ability will be measured by the 12-item General Health Questionnaire (GHQ-12) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Spielbergers State Anxiety Inventory (STAI) [ Time Frame: 29th-34th week of gestation and 2 months after delivery ]
    Clinical symptoms of anxiety will be measured by Spielbergers State Anxiety Inventory (STAI) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 29th-34th week of gestation and 2 months after delivery ]
    Sleep quality and sleep disturbances will be measured by the Pittsburgh Sleep Quality Index (PSQI) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Percentage of participants with sick leave [ Time Frame: 29th-34th week of gestation ]
    Percentage of participants with sick leave, no matter cause. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Episodes of hospitalization, measured in number of hospitals admissions [ Time Frame: 2 weeks post partum ]
    Episodes of hospitalization, measured in number of hospitals admissions. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Hospitalization, length of stay [ Time Frame: 2 weeks post partum ]
    The duration of hospitalization will be measured in days (mean and SD). Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Percentage of participants with respectively spontaneous onset of labor or inducted labor [ Time Frame: 2 weeks post partum ]
    Will be measured as spontaneous onset of labor or induced labor. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Use of epidural anaesthesia [ Time Frame: 2 weeks post partum ]
    Use of epidural anaesthesia during delivery, yes or no. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Duration of labor [ Time Frame: 2 weeks post partum ]
    Duration of labor will be measured in hours. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Mode of delivery. Percentage of participants with respectively spontaneous delivery, vacuum extraction or cesarean section [ Time Frame: 2 weeks post partum ]
    Respectively spontaneous delivery, vacuum extraction or cesarean section. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Birth weight in kilograms [ Time Frame: 2 weeks post partum ]
    Birth weight in kilograms, mean and SD. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • Birth length in centimeters [ Time Frame: 2 weeks post partum ]
    Birth length in centimeters, mean and SD. Please see the published study protocol Broberg et al. Trials (2017) 18:210.

  • World Health Organisation Five Well-being Index (WHO-5). [ Time Frame: 2 months after delivery ]
    Five Well-being Index (WHO-5) (mean and SD) or (median and range). Please see the published study protocol Broberg et al. Trials (2017) 18:210.


Estimated Enrollment: 300
Study Start Date: August 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Standard care, mentally vulnerable women
Active Comparator: group exercise
Supervised Group training
Behavioral: group exercise
  1. Group training supervised by Physiotherapists from Copenhagen University Hospital, Rigshospitalet. 70 minutes sessions twice a week for 12 weeks.

    The training consists of 10 minutes of warm up (Borg scale 7-10), 20 minutes of fitness training on exercise bike, tread mill or cross-trainer (Borg scale 11-15), 25 minutes of muscle training and 15 minutes stretching/relaxation, (Borg scale 6).

    The intensity of the training follows national recommendations on physical activity for pregnant women, which recommends moderate physical activity or more depending on the pregnant woman's fitness level prior to pregnancy.

  2. The pregnant women´s general practitioners are informed about the intervention and who is participating in the project.
  3. A weekly supportive email.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with depression and/or anxiety requiring treatment within the last ten years, and/or intake of antidepressants in the last three months before conception and/or during pregnancy.
  • Age ≥18 years
  • Singelton pregnancy
  • 17th - 22th week of gestation by intervention start
  • Appropriate Danish language skills
  • Written informed consent

Exclusion Criteria:

  • Age <18 years
  • Multiple pregnancies
  • Abuse problems
  • Eating disorders
  • Women who have been diagnosed with malformations or chromosomal disorder in the fetus
  • Pelvic instability problems in earlier pregnancy (diagnosed by physiotherapist or doctor)
  • Severe obstetric complications.

Withdrawal criteria. Participants will be withdrawal from the study after randomization, if one or more of the following criteria are met:

  • Occurred pelvic instability
  • Preeclampsia
  • Vaginal bleeding
  • Other factors indicating an increased risk of preterm birth.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833519


Locations
Denmark
Hanne Kristine Hegaard, Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Hanne K Hegaard, PhD Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet
  More Information

Responsible Party: Hanne Kristine Hegaard, Midwife, PhD, Associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02833519     History of Changes
Other Study ID Numbers: Rigshospitalet, Denmark
First Submitted: May 19, 2016
First Posted: July 14, 2016
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hanne Kristine Hegaard, Rigshospitalet, Denmark:
pregnant women
exercise
depression
anxiety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders