NCT05710003

Brief Summary

To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

Trial Health

35
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 Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 25, 2023

Last Update Submit

January 25, 2023

Conditions

Keywords

dyspneabreathing exercisespregnancy

Outcome Measures

Primary Outcomes (1)

  • Modified dyspnea Borg scale

    Modified Borg Dyspnea Scale is most commonly used to assess symptoms of breathlessness. It has a range from 0 to 10 (with 0 being no exertion and 10 being maximum effort).

    4 weeks

Secondary Outcomes (2)

  • Modified Medical Research Council Dyspnea Scale (mMRC)

    4 weeks

  • London chest activity of Daily Living questionnaire (LCADL)

    4 weeks

Interventions

A-breathing exercises: 20 times per hour. While setting down, deep breathing is taken from the nose while mouth is closed, breath holding for at least ten seconds, then slow maximal exhalation for at least 10 seconds. B-Upper Limb Endurance Exercises (low weight and high repetition) : Study participants will be educated to perform upper limb exercises every 4 hours. Three exercises will be repeated 10×3 times with 1 minute rest in between. Breathing exercise and upper limb endurance exercises is explained in the reminder in details

Also known as: upper limb endurance exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Non physiological causes of dyspnea in pregnancy
  • Cardiac: arrhythmia, constrictive pericarditis , pericardial effusion , coronary heart disease , congestive heart failure , intracardiac shunt , cardiomyopathy , valvular heart disease.
  • Chest wall, pleura, lungs: bronchial asthma, bronchiectasis ,bronchiolitis ,chronic obstructive pulmonary disease, pulmonary emphysema, interstitial lung disease, sarcoidosis ,lung tumor narrowing or compressing the airways , pleural effusion , pulmonary right-to-left shunt , pulmonary hypertension ,elevated hemi diaphragm, phrenic nerve palsy, kyphoscoliosis
  • CNS and neuromuscular: amyotrophic lateral sclerosis , mitochondrial disease polymyositis/ dermatomyositis
  • Metabolic: renal failure , thyroid disease
  • Head and neck : laryngeal tumor ,vocal cord paralysis , vocal cord dysfunction , tumor compressing the upper airways , tracheal stenosis , goiter
  • Others: anemia , anxiety disorder, panic attacks, , ascites , obesity, abdominal wall hernia
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lee SY, Chien DK, Huang CH, Shih SC, Lee WC, Chang WH. Dyspnea in pregnancy. Taiwan J Obstet Gynecol. 2017 Aug;56(4):432-436. doi: 10.1016/j.tjog.2017.04.035.

    PMID: 28805596BACKGROUND
  • Hegewald MJ, Crapo RO. Respiratory physiology in pregnancy. Clin Chest Med. 2011 Mar;32(1):1-13. doi: 10.1016/j.ccm.2010.11.001.

    PMID: 21277444BACKGROUND
  • Melzer K, Schutz Y, Boulvain M, Kayser B. Physical activity and pregnancy: cardiovascular adaptations, recommendations and pregnancy outcomes. Sports Med. 2010 Jun 1;40(6):493-507. doi: 10.2165/11532290-000000000-00000.

    PMID: 20524714BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Entsar Hsanen, university lecturer

CONTACT

Mohammed Gamal, university lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
single group pf patients and follow up effect of breathing exercises and upper limb exercises in perceived dyspnea and quality of life(fatigue scores)
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study will include pregnant ladies presented to respiratory outpatient clinic with physiological dyspnea at the third trimester of pregnancy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 2, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01