Effects of Structured Exercise Regime in Gestational Diabetes Mellitus

NCT04146740 | Completed

• 1 other identifier: FUI/CTR/2019/1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Diabetes Mellitus

Keywords

exercise; pregnancy

Outcome Measures

Primary Outcomes (8)

• HbA1c

  HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.

  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.

  5 weeks

• Lipid profile

  Lipid profile will be assessed at the base line and at the end of 5 weeks session

  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.

  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.

  5 weeks

• Heart rate

  Change in the heart rate will be assessed at base line and at the end of 5 weeks session.

  5 weeks

• Respiratory rate

  Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.

  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.

  5 weeks

Secondary Outcomes (2)

• Gestational weight gain

  5 weeks

• Edinburgh Post Natal Depression scale (Punjabi version)

  5 weeks

Study Arms (2)

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.

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.

Behavioral: Control treatment for both groups

Interventions

Structured Exercise for Experimental (Structured Exercise) Group OTHER

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.

Structured Exercise Group

Control treatment for both groups BEHAVIORAL

Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.

Control Group; Structured Exercise Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Females only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• \. Diagnosed neurological and cardiopulmonary problems.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 45710, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 26810272 BACKGROUND

• Wang 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.

  PMID: 29063044 BACKGROUND

• Bain 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.

  PMID: 25864059 BACKGROUND

• Barquiel 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.

  PMID: 26918922 BACKGROUND

• Brankica 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.

  PMID: 26909480 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD*

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: October 31, 2019
• Study Start: March 12, 2019
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)