Pregnancy RelatedNCT05946408
Effects of Antenatal Exercises in Primagravida
A study testing Supervised antenatal exercises and Antenatal Education in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this Randomized control trial is to determine the effects of antenatal exercises on low back pain in Primagravida. The main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Supervised antenatal exercises and Antenatal Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jul 2023to 21 Dec 2023
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primagravida
- Single pregnancy
- Diagnosed for risk of Prenatal depression on EDPS >10
- Pregnancy related Low back pain score of 3 to 8 on NPRS for at least 2 weeks.
- Females in 2nd Trimester of pregnancy
Who cannot join
- Any present or previous pelvic floor dysfunctions diagnosed by health professionals.
- Any physical disability causing inability to perform physical exercises.
- Any contraindications to physical activity according to ACOG
- Pelvic girdle pain (Anterior: Pubic symphysis, Posterior: SI joint Pain, Gluteal Pain, Piriformis syndrome).
- Rheumatoid disorders.
- Low back pain with radiation
- Not engaged in regular exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Supervised Antenatal Exercises On Low Back Pain And Depression In Primigravida
The goal of this Randomized control trial is to determine the effects of antenatal exercises on low back pain in Primagravida. The main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida.
Read the detailed description
Females usually tend to avoid physical activity during pregnancy. Concept of antenatal exercises and its effects on low back pain or antenatal depression is yet not common amongst pregnant females in Pakistan. Low back pain and antenatal depression are common in pregnancy. These can have an impact on both their own health and the health of their unborn child. Understanding the benefits of antenatal exercises will encourage pregnant females to engage in regular physical activity. The results of this study will help physical therapists to implement effective exercise interventions for this population.
- Conditions
- Pregnancy Related
- Being tested
- Supervised antenatal exercises, Antenatal Education
- Keywords
- Pregnancy Related, antenatal depression, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised antenatal exercisesOther
Supervised antenatal exercises along with education twice a week. Protocol consists of warm up (10 min), Aerobic training (20 mins, 60-75% of max. HR), Strength training (25 minutes), followed by a cool down of 15 minutes.
The Interventions to be provided for a period of 12 weeks.
Antenatal EducationOther
Antenatal education at 12th week of pregnancy. Which consists of education on Posture in pregnancy, Role of pelvic floor muscles, Labor and breathing and relaxation techniques.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Antenatal Exercises | Experimental | Supervised antenatal exercises twice a week an antenatal education Receives: Other: Supervised antenatal exercises |
| Antenatal Education | Active comparator | Antenatal education only Receives: Other: Antenatal Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Changes from baseline low back pain will be assessed on Numeric pain rating scale. The scale ranges from 0 for no pain to 10 for worse pain.
Measured: 12th Week
The Roland Morris Low Back Pain and Disability Questionnaire
Changes from baseline low back pain related disability will be assessed using Roland Morris low back pain and disability questionnaire. It is a self-report questionnaire consisting of 24 questions that are scored on a dichotomous scale (yes/no). The total score ranges from 0 to 24, with higher scores indicating greater disability.
Measured: 12th Week
Beck depression inventory
Changes from baseline antenatal depression will be assessed using Beck depression inventory. A total score of 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms
Measured: 12th week
Secondary outcomes (2)
Multidimensional Fatigue Inventory
Changes from baseline fatigue will be assessed using Multidimensional Fatigue Inventory. The MFI is a 20-item scale designed to evaluate five dimensions of fatigue:
general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Items are scored on a scale of 1 to 5. For the total score, a higher score represent greater fatigue.
Measured: 12th week
Fear of Childbirth Questionnaire
Changes from baseline The Fear of Childbirth Questionnaire (FCQ) this is 20 item questionnaires for women who are pregnant. Items are scored on a scale of 1 to 5. A higher score indicates greater fear
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start5 Jul 2023
- Primary completion1 Dec 2023
- Study completion21 Dec 2023
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946408
- Sponsor's protocol ID
- REC/01546
- Status last verified
- Dec 2023
- First submitted
- 7 Jul 2023
- Last updated
- 29 Dec 2023
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Supervised Antenatal Exercises On Low Back Pain And Depression In Primigravida
- ClinicalTrials.gov ID
- NCT05946408
- Acronym / sponsor ID
- REC/01546
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy Related, antenatal depression, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 14 Jul 2023 (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.
The goal of this Randomized control trial is to determine the effects of antenatal exercises on low back pain in Primagravida. The main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida.
Detailed description
Females usually tend to avoid physical activity during pregnancy. Concept of antenatal exercises and its effects on low back pain or antenatal depression is yet not common amongst pregnant females in Pakistan. Low back pain and antenatal depression are common in pregnancy. These can have an impact on both their own health and the health of their unborn child. Understanding the benefits of antenatal exercises will encourage pregnant females to engage in regular physical activity. The results of this study will help physical therapists to implement effective exercise interventions for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Antenatal Exercises | Experimental | Other: Supervised antenatal exercisesSupervised antenatal exercises twice a week an antenatal education |
| Antenatal Education | Active comparator | Other: Antenatal EducationAntenatal education only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primagravida
- Single pregnancy
- Diagnosed for risk of Prenatal depression on EDPS >10
- Pregnancy related Low back pain score of 3 to 8 on NPRS for at least 2 weeks.
- Females in 2nd Trimester of pregnancy
Key exclusion criteria (7 listed)
- Any present or previous pelvic floor dysfunctions diagnosed by health professionals.
- Any physical disability causing inability to perform physical exercises.
- Any contraindications to physical activity according to ACOG
- Pelvic girdle pain (Anterior: Pubic symphysis, Posterior: SI joint Pain, Gluteal Pain, Piriformis syndrome).
- Rheumatoid disorders.
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 |
|---|---|---|
| Supervised antenatal exercisesSupervised antenatal exercises along with education twice a week. Protocol consists of warm up (10 min), Aerobic training (20 mins, 60-75% of max. HR), Strength training (25 minutes), followed by a cool down of 15 minutes. The Interventions to be provided for a period of 12 weeks. | Other | Supervised Antenatal Exercises |
| Antenatal EducationAntenatal education at 12th week of pregnancy. Which consists of education on Posture in pregnancy, Role of pelvic floor muscles, Labor and breathing and relaxation techniques. | Other | Antenatal Education |
Primary outcome
Low back pain
Time frame: 12th Week
Changes from baseline low back pain will be assessed on Numeric pain rating scale. The scale ranges from 0 for no pain to 10 for worse pain.
The Roland Morris Low Back Pain and Disability Questionnaire
Time frame: 12th Week
Changes from baseline low back pain related disability will be assessed using Roland Morris low back pain and disability questionnaire. It is a self-report questionnaire consisting of 24 questions that are scored on a dichotomous scale (yes/no). The total score ranges from 0 to 24, with higher scores indicating greater disability.
Beck depression inventory
Time frame: 12th week
Changes from baseline antenatal depression will be assessed using Beck depression inventory. A total score of 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms
2 secondary outcomes
Multidimensional Fatigue Inventory
Time frame: 12th week
Fear of Childbirth Questionnaire
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- 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.
Sarah Ehsan, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised antenatal exercises and Antenatal Education in people with Pregnancy Related, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 29 Dec 2023. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low back pain (time frame: 12th Week). The study lists 3 primary outcomes in all. 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 29 Dec 2023.