Gestational Diabetes MellitusNCT04146740
Effects of Structured Exercise Regime in Gestational Diabetes Mellitus
A study testing Structured Exercise for Experimental (Structured Exercise) Group in people with Gestational Diabetes Mellitus, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Rehabilitation in the field of Obstetrics is an emerging field worldwide although it is still very much neglected in a country like Pakistan. Increasing prevalence of GDM has highlighted the importance of rehabilitation in this specific area. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Structured Exercise for Experimental (Structured Exercise) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Mar 2019to 27 Aug 2020
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with age of 20 to 40 years and gestational age more than 20 weeks.
- Diagnosed Gestational diabetes mellitus patients
- Must be able to do 6 min walk test and lie under severity level 6 on the 0-10 Borg scale of breathlessness -
Who cannot join
- 1. Diagnosed neurological and cardiopulmonary problems.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Structured Exercise Regime for the Management of Gestational Diabetes Mellitus (GDM) - Bio Psychosocial Perspectives.
Rehabilitation in the field of Obstetrics is an emerging field worldwide although it is still very much neglected in a country like Pakistan. Increasing prevalence of GDM has highlighted the importance of rehabilitation in this specific area. In USA upto14% of pregnancies get GDM problem, 6.8 to 10.4 % in China while in India 27.5% which is exceptionally high. Similarly in Pakistan it has become a common issue.
Many observational studies have been done to find the risk factors and causes of GDM. However to the best of investigator's knowledge no experimental study have been done so far on the effects of exercise on physical, physiological and psychological aspects of GDM. Hence a randomized control trial is planned on diagnosed GDM patients in Fauji Foundation Hospital Rawalpindi who will recieve supervised structured exercise regeme for 5 weeks and their data will be recorded using reliable tools at the baseline and after 5 weeks to assess the effects of exercise.
Read the detailed description
GDM is a medical condition of high maternal glucose level which is diagnosed only when women are pregnant and overcome after pregnancy. It results in various maternal and neonatal complications like caeserean delivery in mothers and obesity in children. Women having GDM have greater risk of diabetes and cardiovascular problems later in life which is threatening for us. Obese women are at increased risk of developing GDM and it is also a risk factor for developing high blood pressure and protein in the urine after 20 weeks of pregnancy that condition is known as preeclampsia.
Many studies have shown that physically active women are less prone to develop GDM as compare to those women who have sedentary life style which draws attention towards the role of antenatal exercises for prevention and management of GDM and has become the first line treatment in developed countries. In addition to obesity and sedentary life style other known risk factors are family history, age of mother and number of children but there is no definite single cause of GDM yet discovered.
Exercises programs during pregnancy are not usually practiced in our population and routine domestic activities are considered as enough for fitness. We have a common myth that pregnant women should not do treadmill or stationary cycle or any other aerobic activity which is really wrong and resulting in problems like GDM. Women following moderate exercise programs during their pregnancy have reported reduction in daily insulin administration dosage in comparison with women not doing any prescribed exercise. As Gestational weight gain is a major risk factor for GDM, exercises have given evidence to facilitate weight reduction.
Exercise programs prescribed by physical therapists during pregnancy for preventing and managing GDM are considered useful and recommended by researchers and practitioners around the world but in developing countries like Pakistan, women are not receiving this method of treatment due to lack of awareness in general public, lack of referral system from gynaecologists and obstetricians and unavailability of women health Physical therapists in hospital set ups.
This study will provide data showing the effects of exercise in biomarkers level and give the option of treatment to obstetricians.
This will fill the research gap in the area of rehabilitation in GDM. This will also highlight the importance of women health physical therapists in obstetric conditions as there is less awareness of this speciality in Pakistan.
This will provide the data regarding which type, intensity and duration of exercise should be recommendable while treating GDM.
This study will open new doors for researchers to do long term studies on different biomarkers with different exercise types.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Structured Exercise for Experimental (Structured Exercise) Group, Control treatment for both groups
- Keywords
- exercise, pregnancy
- Medical subject headings
- Diabetes, Gestational, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise for Experimental (Structured Exercise) GroupOther
Structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min.
The combination of Stabilization exercise (10 repeatitions) and PFM training ( 20 repeatitions set).
Relaxation therapy including Mitchells physiological relaxation technique (10 repetitions) along with deep breathing exercises.
Control treatment for both groupsBehavioural
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
| Study group | Role | What they receive |
|---|---|---|
| Structured Exercise Group | Experimental | Structured Exercise Group will receive medical and dietary interventions like insulin plus structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min The combination of Stabilization exercise (10 repetitions) and PFM training ( 20 repetitions set).
Relaxation therapy including Mitchells physiological relaxation technique (10 repeatitions) alongwith deep breathing exercises.
Life style modification with postural guidance and back care would also be followed.
Exercise dosage would be twice a week for 05 weeks while exercise duration will be 45 to 50 min session under Physio supervision and home plan of 10 min exercise daily. Total 150 min per week. Data will be recorded at baseline then after treatment of 5 weeks. Receives: Other: Structured Exercise for Experimental (Structured Exercise) Group; Behavioral: Control treatment for both groups |
| Control Group | Active comparator | Control Group will receive no structured exercise regime only the group will be receiving medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist due to ethical concerns and their outcomes will be observed at the baseline and then after 05 weeks. Receives: Behavioral: Control treatment for both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Measured: 5 weeks
Blood Pressure
Change in the Values of Blood pressure will be assessed at base line and at the end of 5 weeks session.
Measured: 5 weeks
Lipid profile
Lipid profile will be assessed at the base line and at the end of 5 weeks session
Measured: 5 weeks
Renal function test (RFT)
RFT will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Measured: 5 weeks
C reactive protein
C reactive protein will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Measured: 5 weeks
Heart rate
Change in the heart rate will be assessed at base line and at the end of 5 weeks session.
Measured: 5 weeks
Respiratory rate
Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.
Measured: 5 weeks
Blood glucose level
Change in the blood glucose level will be assessed at base line and at the end of 5 weeks session.
Measured: 5 weeks
Secondary outcomes (2)
Gestational weight gain
Gestational weight gain by recording weight of women in pounds and gestational age in weeks at baseline and then after 5 weeks.
Measured: 5 weeks
Edinburgh Post Natal Depression scale (Punjabi version)
The score of Depression using Edinburgh Post Natal Depression scale (Punjabi version). Each answer is given on a score of 0-3 . Maximum score is 30 A score of 10 or higher indicates that depressive symptoms have been
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start12 Mar 2019
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD*, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146740
- Sponsor's protocol ID
- FUI/CTR/2019/1
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aviram A, Guy L, Ashwal E, Hiersch L, Yogev Y, Hadar E. Pregnancy outcome in pregnancies complicated with gestational diabetes mellitus and late preterm birth. Diabetes Res Clin Pract. 2016 Mar;113:198-203. doi: 10.1016/j.diabres.2015.12.018. Epub 2016 Jan 12.
PubMed 26810272Wang C, Guelfi KJ, Yang HX. Exercise and its role in gestational diabetes mellitus. Chronic Dis Transl Med. 2016 Dec 20;2(4):208-214. doi: 10.1016/j.cdtm.2016.11.006. eCollection 2016 Dec.
PubMed 29063044Bain E, Crane M, Tieu J, Han S, Crowther CA, Middleton P. Diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2015 Apr 12;(4):CD010443. doi: 10.1002/14651858.CD010443.pub2.
PubMed 25864059Barquiel B, Herranz L, Hillman N, Burgos MA, Grande C, Tukia KM, Bartha JL, Pallardo LF. HbA1c and Gestational Weight Gain Are Factors that Influence Neonatal Outcome in Mothers with Gestational Diabetes. J Womens Health (Larchmt). 2016 Jun;25(6):579-85. doi: 10.1089/jwh.2015.5432. Epub 2016 Feb 26.
PubMed 26918922Brankica K, Valentina VN, Slagjana SK, Sasha JM. Maternal 75-g OGTT glucose levels as predictive factors for large-for-gestational age newborns in women with gestational diabetes mellitus. Arch Endocrinol Metab. 2016 Feb;60(1):36-41. doi: 10.1590/2359-3997000000126.
PubMed 26909480
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Structured Exercise Regime for the Management of Gestational Diabetes Mellitus (GDM) - Bio Psychosocial Perspectives.
- ClinicalTrials.gov ID
- NCT04146740
- Acronym / sponsor ID
- FUI/CTR/2019/1
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- exercise, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 31 Oct 2019 (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.
Rehabilitation in the field of Obstetrics is an emerging field worldwide although it is still very much neglected in a country like Pakistan. Increasing prevalence of GDM has highlighted the importance of rehabilitation in this specific area. In USA upto14% of pregnancies get GDM problem, 6.8 to 10.4 % in China while in India 27.5% which is exceptionally high. Similarly in Pakistan it has become a common issue.
Many observational studies have been done to find the risk factors and causes of GDM. However to the best of investigator's knowledge no experimental study have been done so far on the effects of exercise on physical, physiological and psychological aspects of GDM. Hence a randomized control trial is planned on diagnosed GDM patients in Fauji Foundation Hospital Rawalpindi who will recieve supervised structured exercise regeme for 5 weeks and their data will be recorded using reliable tools at the baseline and after 5 weeks to assess the effects of exercise.
Detailed description
GDM is a medical condition of high maternal glucose level which is diagnosed only when women are pregnant and overcome after pregnancy. It results in various maternal and neonatal complications like caeserean delivery in mothers and obesity in children. Women having GDM have greater risk of diabetes and cardiovascular problems later in life which is threatening for us. Obese women are at increased risk of developing GDM and it is also a risk factor for developing high blood pressure and protein in the urine after 20 weeks of pregnancy that condition is known as preeclampsia.
Many studies have shown that physically active women are less prone to develop GDM as compare to those women who have sedentary life style which draws attention towards the role of antenatal exercises for prevention and management of GDM and has become the first line treatment in developed countries. In addition to obesity and sedentary life style other known risk factors are family history, age of mother and number of children but there is no definite single cause of GDM yet discovered.
Exercises programs during pregnancy are not usually practiced in our population and routine domestic activities are considered as enough for fitness. We have a common myth that pregnant women should not do treadmill or stationary cycle or any other aerobic activity which is really wrong and resulting in problems like GDM. Women following moderate exercise programs during their pregnancy have reported reduction in daily insulin administration dosage in comparison with women not doing any prescribed exercise. As Gestational weight gain is a major risk factor for GDM, exercises have given evidence to facilitate weight reduction.
Exercise programs prescribed by physical therapists during pregnancy for preventing and managing GDM are considered useful and recommended by researchers and practitioners around the world but in developing countries like Pakistan, women are not receiving this method of treatment due to lack of awareness in general public, lack of referral system from gynaecologists and obstetricians and unavailability of women health Physical therapists in hospital set ups.
This study will provide data showing the effects of exercise in biomarkers level and give the option of treatment to obstetricians.
This will fill the research gap in the area of rehabilitation in GDM. This will also highlight the importance of women health physical therapists in obstetric conditions as there is less awareness of this speciality in Pakistan.
This will provide the data regarding which type, intensity and duration of exercise should be recommendable while treating GDM.
This study will open new doors for researchers to do long term studies on different biomarkers with different exercise types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Exercise Group | Experimental | Other: Structured Exercise for Experimental (Structured Exercise) Group, Behavioral: Control treatment for both groupsStructured Exercise Group will receive medical and dietary interventions like insulin plus structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min The combination of Stabilization exercise (10 repetitions) and PFM training ( 20 repetitions set). Relaxation therapy including Mitchells physiological relaxation technique (10 repeatitions) alongwith deep breathing exercises. Life style modification with postural guidance and back care would also be followed. Exercise dosage would be twice a week for 05 weeks while exercise duration will be 45 to 50 min session under Physio supervision and home plan of 10 min exercise daily. Total 150 min per week. Data will be recorded at baseline then after treatment of 5 weeks. |
| Control Group | Active comparator | Behavioral: Control treatment for both groupsControl Group will receive no structured exercise regime only the group will be receiving medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist due to ethical concerns and their outcomes will be observed at the baseline and then after 05 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with age of 20 to 40 years and gestational age more than 20 weeks.
- Diagnosed Gestational diabetes mellitus patients
- Must be able to do 6 min walk test and lie under severity level 6 on the 0-10 Borg scale of breathlessness -
Key exclusion criteria (2 listed)
- 1. Diagnosed neurological and cardiopulmonary problems.
- -
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 |
|---|---|---|
| Structured Exercise for Experimental (Structured Exercise) GroupStructured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min. The combination of Stabilization exercise (10 repeatitions) and PFM training ( 20 repeatitions set). Relaxation therapy including Mitchells physiological relaxation technique (10 repetitions) along with deep breathing exercises. | Other | Structured Exercise Group |
| Control treatment for both groupsMedical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist. | Behavioural | Control Group, Structured Exercise Group |
Primary outcome
HbA1c
Time frame: 5 weeks
HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Blood Pressure
Time frame: 5 weeks
Change in the Values of Blood pressure will be assessed at base line and at the end of 5 weeks session.
Lipid profile
Time frame: 5 weeks
Lipid profile will be assessed at the base line and at the end of 5 weeks session
Renal function test (RFT)
Time frame: 5 weeks
RFT will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
C reactive protein
Time frame: 5 weeks
C reactive protein will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Heart rate
Time frame: 5 weeks
Change in the heart rate will be assessed at base line and at the end of 5 weeks session.
Respiratory rate
Time frame: 5 weeks
Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.
Blood glucose level
Time frame: 5 weeks
Change in the blood glucose level will be assessed at base line and at the end of 5 weeks session.
2 secondary outcomes
Gestational weight gain
Time frame: 5 weeks
Edinburgh Post Natal Depression scale (Punjabi version)
Time frame: 5 weeks
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 31 Aug 2020.
- Background: PubMed 26810272Aviram A, Guy L, Ashwal E, Hiersch L, Yogev Y, Hadar E. Pregnancy outcome in pregnancies complicated with gestational diabetes mellitus and late preterm birth. Diabetes Res Clin Pract. 2016 Mar;113:198-203. doi: 10.1016/j.diabres.2015.12.018. Epub 2016 Jan 12.
- Background: PubMed 29063044Wang C, Guelfi KJ, Yang HX. Exercise and its role in gestational diabetes mellitus. Chronic Dis Transl Med. 2016 Dec 20;2(4):208-214. doi: 10.1016/j.cdtm.2016.11.006. eCollection 2016 Dec.
- Background: PubMed 25864059Bain E, Crane M, Tieu J, Han S, Crowther CA, Middleton P. Diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2015 Apr 12;(4):CD010443. doi: 10.1002/14651858.CD010443.pub2.
- Background: PubMed 26918922Barquiel B, Herranz L, Hillman N, Burgos MA, Grande C, Tukia KM, Bartha JL, Pallardo LF. HbA1c and Gestational Weight Gain Are Factors that Influence Neonatal Outcome in Mothers with Gestational Diabetes. J Womens Health (Larchmt). 2016 Jun;25(6):579-85. doi: 10.1089/jwh.2015.5432. Epub 2016 Feb 26.
- Background: PubMed 26909480Brankica K, Valentina VN, Slagjana SK, Sasha JM. Maternal 75-g OGTT glucose levels as predictive factors for large-for-gestational age newborns in women with gestational diabetes mellitus. Arch Endocrinol Metab. 2016 Feb;60(1):36-41. doi: 10.1590/2359-3997000000126.
- 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.
Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD* principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise for Experimental (Structured Exercise) Group in people with Gestational Diabetes Mellitus, run by Foundation University Islamabad 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 3 inclusion and 2 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 31 Aug 2020. 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?
HbA1c (time frame: 5 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146740, which also lists 5 linked publications.
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 31 Aug 2020.