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OpenTrials
Completed

NCT Number: NCT02239341

Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.

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Key information

Conditions

High-Risk Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized high-risk pregnant women in hospital for at least 7 days
  • Diagnosed with gestational hypertension
  • Diagnosed with preeclampsia (mild to moderate)
  • Diagnosed with intrauterine growth restriction
  • Single baby
  • Expecting twins
  • Expecting triplets
  • Diagnosed with shortened cervix
  • Diagnosed with threatened pre-term labour (not actively contracting)

Exclusion criteria

  • Diagnosed with symptomatic placenta previa (bleeding)
  • Diagnosed with severe pre-eclampsia (immediate delivery)
  • Diagnosed with conditions indicating a short term hospital stays of less than 7 days
  • Diagnosed with infections
  • Diagnosed with heart and renal disease
  • Diagnosed with diabetes
  • Diagnosed with metabolic bone disease
  • Diagnosed with hyper-or-hypo-thyroidism
  • Diagnosed with Cushing disease and anemia
  • Women carrying more than 3 babies

Treatment and study plan

Music intervention

Other

Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.

Muscle Conditioning Intervention

Other

Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones and also participate in the muscle conditioning program while in bed.

Primary outcomes

  1. Score on the Functional Mobility Assessment Tool

    Time frame: 2 weeks post delivery

    The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test).

Secondary outcomes

  1. Quality of life

    Time frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery

    The secondary outcome of the study is to examine quality of life in the postpartum period. Quality of life will be measured by completing four surveys the EQ-5D, and the Postpartum Psychological Profile Questionnaire which includes the Depression Scale (1 page), the State Anxiety Index (1 page) and the Postpartum Physical and Psychological Symptoms Report .

  2. Follow up to Primary outcome Score for Functional Mobility Assessment Tool

    Time frame: 2, 6 and 12 months

    Changes over time within groups and between groups in the post partum period

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2014
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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