Pregnancy RelatedNCT05710003
Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
A study testing breathing exercises in people with Pregnancy Related and Dyspnea, run by Entsar Hsanen.
Trial summary
To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Dyspnea
- What is being tested?
- breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Dec 2023
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
- Inclusion criteria: pregnant women presented with physiological dyspnea.
- Exclusion criteria:
- 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
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea
Read the detailed description
Pregnant women undergo various anatomical and physiological changes so that they can cope with the increased physical and metabolic demands of their pregnancies. Cardiovascular, respiratory, haematological, renal, gastrointestinal and endocrine systems undergo important physiological adaptations needed to allow development of the fetus and to allow the mother and fetus to survive the demands of childbirth . On the other hand, dyspnea can be caused by pregnancy complications, thus requiring specific medical treatment. Shortness of breath is common during pregnancy, occurring in 60% to 70% of healthy pregnant women . The aim of the study is to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea
- Conditions
- Pregnancy Related, Dyspnea
- Being tested
- breathing exercises
- Keywords
- dyspnea, breathing exercises, pregnancy
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercisesBehavioural
Also called upper limb endurance exercises
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (2)
Modified Medical Research Council Dyspnea Scale (mMRC)
allows the patients to indicate the extent to which their breathlessness affects their mobility.
The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.
Measured: 4 weeks
London chest activity of Daily Living questionnaire (LCADL)
It consist of four domains Selfcare, domestic activities, physical activities and leisure activities.
Selfcare, domestic, physical and leisure activities contains 4, 6, 2 and 3 items respectively. Each item is graded by numbers 0-5, 0 mean little or no dyspnea and 5 mean worst dyspnea
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study will include pregnant ladies presented to respiratory outpatient clinic with physiological dyspnea at the third trimester of pregnancy
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entsar Hsanen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Entsar Hsanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710003
- Sponsor's protocol ID
- breathing exercises pregnancy
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28805596Hegewald MJ, Crapo RO. Respiratory physiology in pregnancy. Clin Chest Med. 2011 Mar;32(1):1-13. doi: 10.1016/j.ccm.2010.11.001.
PubMed 21277444Melzer 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.
PubMed 20524714
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea
- ClinicalTrials.gov ID
- NCT05710003
- Acronym / sponsor ID
- breathing exercises pregnancy
- Conditions
- Pregnancy Related, Dyspnea
- Keywords
- dyspnea, breathing exercises, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Entsar HsanenUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea
Detailed description
Pregnant women undergo various anatomical and physiological changes so that they can cope with the increased physical and metabolic demands of their pregnancies. Cardiovascular, respiratory, haematological, renal, gastrointestinal and endocrine systems undergo important physiological adaptations needed to allow development of the fetus and to allow the mother and fetus to survive the demands of childbirth . On the other hand, dyspnea can be caused by pregnancy complications, thus requiring specific medical treatment. Shortness of breath is common during pregnancy, occurring in 60% to 70% of healthy pregnant women . The aim of the study is to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This study will include pregnant ladies presented to respiratory outpatient clinic with physiological dyspnea at the third trimester of pregnancy
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| breathing exercisesAlso: upper limb endurance exercisesA-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 | Behavioural | – |
Primary outcome
Modified dyspnea Borg scale
Time frame: 4 weeks
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).
2 secondary outcomes
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 4 weeks
London chest activity of Daily Living questionnaire (LCADL)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 28805596Lee 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.
- Background: PubMed 21277444Hegewald MJ, Crapo RO. Respiratory physiology in pregnancy. Clin Chest Med. 2011 Mar;32(1):1-13. doi: 10.1016/j.ccm.2010.11.001.
- Background: PubMed 20524714Melzer 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercises in people with Pregnancy Related and Dyspnea, run by Entsar Hsanen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Entsar Hsanen, university lecturer (01019968106, entsar.hsanen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified dyspnea Borg scale (time frame: 4 weeks). 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 NCT05710003, which also lists 3 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 2 Feb 2023.