Pregnancy RelatedNCT03705741
The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women
A study testing Resistance exercise in people with Pregnancy Related and Sedentary Lifestyle, run by Värmland County Council, Sweden at 1 site in Sweden.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sedentary Lifestyle
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 5 Nov 2018to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single pregnancy and ≥18 of age
- Ability to understand verbal and written Swedish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women: a Randomized Controlled Study
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.
Read more
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
- Being tested
- Resistance exercise
- Keywords
- pregnancy, exercise, public health, randomized controlled trial
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
Resistance exercise twice a week during pregnancy week 23-34.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Resistance exercise twice a week Receives: Behavioral: Resistance exercise |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Register at gestational week 22 and 34
Secondary outcomes (12)
Change in anxiety / depression
Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure self-reported anxiety/depression from 0, "no anxiety/depression" to 100, "very great anxiety/depression". The scale is a streight horizontal line.
Measured: Register at gestational week 22 and 34
Change in pain
Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure the intensity of pain from 0, "none pain" to 100, "extreme amount of pain". The scale is a streight horizontal line.
Measured: Register at gestational week 22 and 34
Change in Health Related Quality of Life
Visual Analogue Scale (EQ-VAS). Mark health status on the day on a 20 centimeters vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: Register at gestational week 22 and 34
Change in blood pressure
Systolic and Diastolic
Measured: From perinatal records. Registered at gestational week 22 and 34
Change in weight gain
kilogram
Measured: from perinatal records. Registered at gestational week 22 and 34
Gestational Diabetes Mellitus (GDM)
Development of GDM
Measured: from perinatal records. Registered at gestational week 34
Change in exercise
Minutes a day. (Walks, light, moderate, vigorous intensity).
Measured: Registered at gestational week 22 and 34
Birth weight
kilogram
Measured: from perinatal records at birth (gestational week 40)
Birth length
centimeters
Measured: from perinatal records at birth (gestational week 40)
Gestational age
days
Measured: From perinatal records at birth (gestational week 40)
Acute cesarean section
rate
Measured: from perinatal records at birth (gestational week 40)
Macrosomia
rate of birth with macrosomia
Measured: from perinatal records at birth (gestational week 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start5 Nov 2018
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Why it stopped: Covid-19 In summary, 48 persons were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ylva Karolina Petrov Fieril, Värmland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705741
- Sponsor's protocol ID
- 2018/246
- Status last verified
- Sep 2023
- First submitted
- 3 Oct 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03705741
- Acronym / sponsor ID
- 2018/246
- Conditions
- Pregnancy Related, Sedentary Lifestyle
- Keywords
- pregnancy, exercise, public health, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 In summary, 48 persons were included.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Resistance exerciseResistance exercise twice a week |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single pregnancy and ≥18 of age
- Ability to understand verbal and written Swedish
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseResistance exercise twice a week during pregnancy week 23-34. | Behavioural | Exercise group |
Primary outcome
Change in fatigue
Time frame: Register at gestational week 22 and 34
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.
12 secondary outcomes
Change in anxiety / depression
Time frame: Register at gestational week 22 and 34
Change in pain
Time frame: Register at gestational week 22 and 34
Change in Health Related Quality of Life
Time frame: Register at gestational week 22 and 34
Change in blood pressure
Time frame: From perinatal records. Registered at gestational week 22 and 34
Change in weight gain
Time frame: from perinatal records. Registered at gestational week 22 and 34
Gestational Diabetes Mellitus (GDM)
Time frame: from perinatal records. Registered at gestational week 34
Change in exercise
Time frame: Registered at gestational week 22 and 34
Birth weight
Time frame: from perinatal records at birth (gestational week 40)
Birth length
Time frame: from perinatal records at birth (gestational week 40)
Gestational age
Time frame: From perinatal records at birth (gestational week 40)
Acute cesarean section
Time frame: from perinatal records at birth (gestational week 40)
Macrosomia
Time frame: from perinatal records at birth (gestational week 40)
Results and safety
The study was stopped early (reason given: Covid-19 In summary, 48 persons were included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Pregnancy Related and Sedentary Lifestyle, run by Värmland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 In summary, 48 persons were included.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: Register at gestational week 22 and 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.