The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women

NCT03705741 | Terminated

• 1 other identifier: 2018/246
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Maintaining a physically active lifestyle is associated with many health benefits, including lower risk of cardiovascular disease, diabetes, hypertension, some type of cancer, and depression . Pregnant, healthy women are recommended to do 30 minutes or more of light to moderate exercise a day, although most women in the Western world do not follow current recommendations and decrease their exercise level. Benefits of exercise during pregnancy are several, including a protective effect against the development of gestational diabetes mellitus, reduced pregnancy related low back pain, and risk of caesarean delivery. On the contrary, a recent review concludes that sedentary behaviors are associated with higher levels of C Reactive Protein and LDL Cholesterol, a larger newborn abdominal circumference, and macrosomia. Previous studies show that exercise during pregnancy is associated with improvements in psychological well-being among previously sedentary women. Only a few RCT's have studied resistance exercise during pregnancy. These studies have found reduced fatigue and reduced need of insulin among women with gestational diabetes mellitus who did resistance exercise, with no adverse effects on fetus or the pregnant woman. The aim of this study is to evaluate the efficacy of regular light -to-moderate resistance exercise among sedentary pregnant woman, with regard to fatigue, health related quality of life, pain location and intensity, body weight gain, blood pressure, and childbirth outcomes.

Conditions

Pregnancy Related; Sedentary Lifestyle

Keywords

pregnancy; exercise; public health; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

  Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure self-reported fatigue from 0, "no fatigue" to 100, "very great fatigue". The scale is a streight horizontal line.

  Register at gestational week 22 and 34

Secondary Outcomes (12)

• Change in anxiety / depression

  Register at gestational week 22 and 34

• Change in pain

  Register at gestational week 22 and 34

• Change in Health Related Quality of Life

  Register at gestational week 22 and 34

• Change in blood pressure

  From perinatal records. Registered at gestational week 22 and 34

• Change in weight gain

  from perinatal records. Registered at gestational week 22 and 34

Study Arms (2)

Exercise group

EXPERIMENTAL

Resistance exercise twice a week

Behavioral: Resistance exercise

Control group

NO INTERVENTION

Interventions

Resistance exercise BEHAVIORAL

Resistance exercise twice a week during pregnancy week 23-34.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single pregnancy and ≥18 of age
• Ability to understand verbal and written Swedish

You may not qualify if:

• Follows the recommendation regarding contraindications according to the American Collage of Obstetricians and Gynecologists 2002
• Severe pain from the pelvic or the back
• Regular exercise \>150 minutes per week the last six months

Sponsors & Collaborators

• Värmland County Council, Sweden: lead

Study Sites (1)

Fysioterapimottagningen Gripen

Karlstad, 65224, Sweden

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes, which are randomly picked out before the meeting with each participant
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Fysiotherapist, PhD

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 15, 2018
• Study Start: November 5, 2018
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 17, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)