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

High-Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239341
• Other study ID #: 105699
• Status: Completed
• Phase: N/A
• Start date: October 30, 2014
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High-Risk Pregnancy

Intervention

Other:
• Music Intervention
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
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Functional Mobility Assessment Tool	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).	2 weeks post delivery
Secondary	Quality of life	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 .	Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery
Secondary	Follow up to Primary outcome Score for Functional Mobility Assessment Tool	Changes over time within groups and between groups in the post partum period	2, 6 and 12 months