Home » Trials » SLCTR/2025/021


Effectiveness of aerobic exercises on stress level, sleep quality and cardiovascular fitness on pregnant women.

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SLCTR Registration Number

SLCTR/2025/021


Date of Registration

05 Jun 2025

The date of last modification

Jun 05, 2025



Application Summary


Scientific Title of Trial

Effectiveness of aerobic exercises on stress level, sleep quality and cardiovascular fitness on pregnant women.


Public Title of Trial

Effectiveness of an aerobic exercise programme compared to routine maternal care on stress level, sleep quality and cardiovascular fitness among pregnant women.


Disease or Health Condition(s) Studied

Pregnancy


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1319-8902


Any other number(s) assigned to the trial and issuing authority

2024/EC/48- ERC


Trial Details


What is the research question being addressed?

Is aerobic exercises effective in improving stress level, sleep quality and cardiovascular fitness among pregnant women compared to routine maternal care?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Data analysts, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Health services research


Study Phase

Not Applicable


Intervention(s) planned

Study setting- Medical Officer of health (MOH) ,Ragama

Randomization- Simple random sampling:

The pregnant mothers registered under MOH-Ragama for their antenatal clinic who consent to participate in the study and satisfy inclusion criteria will be identified and prepare a list according to the alphabetic order. Of these mothers, 70 number of subjects will be selected by random sampling by randomization on SPSS. The selected participants(70) will be randomly allocated either to the control group(35) and to the treatment group(35) using a computer-based random number generation randomization procedure.

The intervention group will be receiving a 8 weeks Aerobic exercise program and routine antenatal care at MOH Ragama.

The control group will be receiving only routine antenatal care for 8 weeks at MOH Ragama. Blinding- Single blinded, Only outcome assessors are blinded.

The intervention group of pregnant women will be given a home aerobic exercise programme. Exercise programme was designed strictly adhered to ACSM guidelines for pregnant women. On the 1st day participants will be asked to come with their husband or family member. Full aerobic exercise steps including 5 minutes warm up, 30 minutes aerobic exercise, 5 minutes cool down will be demonstrated and taught properly for each participant. The exercise programme will be demonstrated by the researcher and the participants will be requested to perform the exercises steps and any deviations will be corrected. They will be instructed to carry out the moderate intensity exercise programme for 8 weeks with a frequency of 4 days per week. Intensity of the exercises will be assessed using Borg scale. In addition, a detailed instruction sheet including clear images of the exercise procedures, instructions and warning signs will be provided to the participants. (Available in English, Sinhala and Tamil). The compliance of the participants will be monitored by regular video call sessions with each subject and if that facility is not accessible by them, regular voice calls will be made. Subjects will be advised to maintain an exercise diary and bring it to their monthly MOH clinic. Principle investigator will review the exercises at monthly MOH clinic. Adherence to the exercise program will be encouraged by the principal investigator who supervises the exercise sessions.


Inclusion criteria

Pregnant women age between 18 to 35 years Pregnant women in their first pregnancy. Pregnant women in their second trimester. Those who are willing to comply with all study procedures and be available for the duration of the study.


Exclusion criteria

History of high blood pressure, restrictive lung disease, chronic medical illnesses, (cancer, renal, endocrine, neurologic, infectious, or cardiovascular diseases) Previously diagnosed sleep disorders, stress disorders, panic attacks or psychiatric disorders currently on treatment. Known cases of severe cognitive, physical, visual and communication impairments Persistent vaginal bleeding after 12 weeks History of miscarriage within last 12 months Multiple gestation at risk for premature labour Diseases related to the reproductive system such as placenta previa Participants of a structured exercise programme within last 6 months Extreme obesity or underweight ( 12>BMI>30 )



Primary outcome(s)

1.

Perceived Stress Scale will be used to assess the stress level of the participants.

[

First day before commencing the intervention and after completion of 8 weeks of intervention

Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama.

]
2.

Pittsburg Sleep Quality index will be used to assess the sleep quality of the participants.

[

First day before commencing the intervention and after completion of 8 weeks of intervention

Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama.

]
3.

Six-minute Walk test will be used to assess the cardiovascular fitness of the participants.

[

First day before commencing the intervention and after completion of 8 weeks of intervention

Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama.

]

Secondary outcome(s)

1.

None

[

None

]

Target number/sample size

70 (35 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2025-06-08


Anticipated end date

2025-09-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

N/A



State of Ethics Review Approval


Status

Approved


Date of Approval

2025-02-24


Approval number

2024/EC/48


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya.
Telephone:0812396361
Email: chairperson.erc@med.pdn.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

U.T.Nawinnna
Post graduate student (MSc in Physiotherapy) of Faculty of Allied Health sciences,University of Peradeniya
Department of Physiotherapy Faculty of Allied Health Sciences, University of Peradeniya, Augusta Hill, Sri Amarawansa mawatha, Peradeniya
0813999623
0712773977

thamali.nawinna@gmail.com
ahs.pdn.ac.lk

Contact Person for Public Queries

Dr Esther Liyanage
Head of the department
Department of Physiotherapy Faculty of Allied Health Sciences, University of Peradeniya, Augusta Hill, Sri Amarawansa mawatha, Peradeniya
0813999623
0716789288

estherl@ahs.ac.lk
ahs.pdn.ac.lk


Primary study sponsor/organization

Medical Officer of Health

2WGC+X35, Ragama
0112 958 035

mohragama@yahoo.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results