NCT05863962

Brief Summary

To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 9, 2023

Last Update Submit

May 9, 2023

Conditions

Pre-Eclampsia; Complicating Pregnancy

Keywords

Pregnancy Toxemia,Muscle Stretching ExerciseHigh Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Mercury sphygmomanomete

    patient have systolic blood pressure of 140 mm Hg or higher and/or a diastolic blood pressure of 90 mm Hg or higher.

    4 Weeks

Secondary Outcomes (1)

  • Pregnancy related anxiety questionnaire

    4 Weeks

Study Arms (2)

Stretching Exercises

EXPERIMENTAL

walking with stretching exercises

Other: walking and Stretching

Jacobson's Technique

ACTIVE COMPARATOR

walking with Jacobson's Relaxation Technique.

Other: walking and Jacobsons relaxation technique

Interventions

walking and StretchingOTHER

Stretching exercise will be given for 6 weeks (3 sessions per week). 15 minutes of moderate walking with stretching exercises 5 times a week with Warm up and Cool down. Videos will be provided to participants to follow at home. Participants will be provided forms for home to fill after every session completed and frequency of each exercise

Stretching Exercises
walking and Jacobsons relaxation techniqueOTHER

Jacobson's Relaxation Technique will be given for 6 weeks. 15 minutes of moderate walking with Jacobson's Relaxation Technique. Videos will be provided to participants to follow at home. Participants will be provided forms for home to fill after every session completed. Participants will also bring their Pedometer

Jacobson's Technique

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age was exceeding 24 weeks
  • BP more than or up to 140/90
  • Diagnosed with gestational Hypertension
  • Primiparous

You may not qualify if:

  • Women with history of preterm labor or repeated abortion
  • Bleeding
  • Intra uterine fetal growth anomalies
  • Underlying mental (depression with severe anxiety)
  • Cardio respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 05499, Pakistan

RECRUITING

Related Publications (10)

  • Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.

    PMID: 30920918BACKGROUND

  • Pacheco-Romero, J., Introduction to the Preeclampsia. Revista Peruana de GinecologĂ­a y Obstetricia, 2017. 63(2): p. 199-206.

    BACKGROUND

  • Nirupama R, Divyashree S, Janhavi P, Muthukumar SP, Ravindra PV. Preeclampsia: Pathophysiology and management. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101975. doi: 10.1016/j.jogoh.2020.101975. Epub 2020 Nov 7.

    PMID: 33171282BACKGROUND

  • Awad MA, Hasanin ME, Taha MM, Gabr AA. Effect of stretching exercises versus autogenic training on preeclampsia. J Exerc Rehabil. 2019 Feb 25;15(1):109-113. doi: 10.12965/jer.1836524.262. eCollection 2019 Feb.

    PMID: 30899745BACKGROUND

  • Ghorbannejad S, MehdizadehTourzani Z, Kabir K, MansourehYazdkhasti. The effectiveness of Jacobson's progressive muscle relaxation technique on maternal, fetal and neonatal outcomes in women with non-severe preeclampsia: a randomized clinical trial. Heliyon. 2022 Jun 13;8(6):e09709. doi: 10.1016/j.heliyon.2022.e09709. eCollection 2022 Jun.

    PMID: 35761936BACKGROUND

  • Naseh, Z., P. Bahadoran, and M. Valiani, Effect of Relaxation Technique on Anxiety, Stress, and Depression Scores of High-risk Pregnant Women Prone to Preeclampsia and the Physiological Indicators of Their Babies. Avicenna Journal of Nursing and Midwifery Care, 2022. 30(3): p. 211-220.

    BACKGROUND

  • Abd El Aliem, R.S., E.M. Abd-Elhakam, and S.A. Mustafa, Effect of Self Independence Physical Stretching Exercise on Feto-maternal Outcomes among Mild Preeclamptic Pregnant Women.

    BACKGROUND

  • Vicente Bertagnolli T, Souza Rangel Machado M, Ferreira CJH, Machado JSR, Duarte G, Cavalli RC. Safety of a physical therapy protocol for women with preeclampsia: a randomized controlled feasibility trial. Hypertens Pregnancy. 2018 May;37(2):59-67. doi: 10.1080/10641955.2018.1439059. Epub 2018 Mar 1.

    PMID: 29495906BACKGROUND

  • Caughey, M.C., et al., Abstract P035: Feasibility of Stretching Exercise for Prevention of Late-Onset Preeclampsia: A Pilot Trial. Circulation, 2018. 137(suppl_1): p. AP035-AP035.

    BACKGROUND

  • Soliman, G.H., S.M.A. Elalem, and S.M. Elhomosy, The effect of relaxation techniques on blood pressure and stress among pregnant women with mild pregnancy induced hypertension. Asian Journal of Nursing Education and Research, 2017. 7(3): p. 321-329.

    BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaPregnancy ComplicationsHypertension

Interventions

Walking

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Hafiza Mehjabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)