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

NCT02833519 | Completed DMC

• 1 other identifier: Rigshospitalet, Denmark
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

pregnant women; exercise; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• World Health Organisation Five Well-being Index (WHO-5).

  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.

  29th-34th week of gestation

Secondary Outcomes (15)

• Edinburgh Postnatal Depression Scale (EPDS)

  29th-34th week of gestation and 2 months after delivery

• The 12-item General Health Questionnaire (GHQ-12)

  29th-34th week of gestation and 2 months after delivery

• Spielbergers State Anxiety Inventory (STAI)

  29th-34th week of gestation and 2 months after delivery

• Pittsburgh Sleep Quality Index (PSQI)

  29th-34th week of gestation and 2 months after delivery

• Percentage of participants with sick leave

  29th-34th week of gestation

Study Arms (2)

control group

NO INTERVENTION

Standard care, mentally vulnerable women

group exercise

ACTIVE COMPARATOR

Supervised Group training

Behavioral: group exercise

Interventions

group exercise BEHAVIORAL

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.

group exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• th - 22th week of gestation by intervention start
• Appropriate Danish language skills
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Hanne Kristine Hegaard, Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Broberg L, Tabor A, Rosthoj S, Backhausen M, Frokjaer VG, Damm P, Hegaard HK. Effect of supervised group exercise on psychological well-being among pregnant women with or at high risk of depression (the EWE Study): A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Jan;100(1):129-138. doi: 10.1111/aogs.13982. Epub 2020 Sep 15.

  PMID: 32862425 DERIVED

• Broberg L, Backhausen M, Damm P, Bech P, Tabor A, Hegaard HK. Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):210. doi: 10.1186/s13063-017-1938-z.

  PMID: 28476136 DERIVED

MeSH Terms

Conditions

Depression; Motor Activity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Hanne K Hegaard, PhD

  Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife, PhD, Associate professor

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 14, 2016
• Study Start: August 1, 2016
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

DK (1)