This trial is active, not recruiting.

Condition high-risk pregnancy
Treatments music intervention, muscle conditioning intervention
Sponsor University of Western Ontario, Canada
Start date October 2014
End date November 2016
Trial size 30 participants
Trial identifier NCT02239341, 105699


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
The M intervention will be 30 minutes (same amount of time as E group), but the participants will simply be listening to the same music in bed with no exercise component. They will be wearing the heart rate monitor as in the E group. The M group will act as a control group for the E group.
music intervention
Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.
E (exercise) is 30 minutes in length and will consist of 5 minutes of warm-up, 20 minutes of light strengthening exercises using a theraband, and 5 minutes of cool-down. All exercises will be completed in bed. Each participant will be listening to the same music (as the M group) during exercise. A heart rate monitor will be worn throughout each session. The first session for each participant will be used to complete baseline measurements and to assess initial muscle strength. Difficulty level will be adjusted by using different strength therabands.
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.

Primary Outcomes

Score on the Functional Mobility Assessment Tool
time frame: 2 weeks post delivery

Secondary Outcomes

Quality of life
time frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery
Follow up to Primary outcome Score for Functional Mobility Assessment Tool
time frame: 2, 6 and 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
Principal investigator Michelle F Mottola, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Western Ontario, Canada.