- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404672
Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome
Effects Of Breathing Exercises With And Without Aerobic Training On Dysfunctional Breathing And Exercise Intolerance In Patients With Postural Orthostatic Tachycardia Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Liaqat Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Only Females
- Age: (15-45years)
- +ve tilt table test
- +ve 10 minutes standing test
- Nijmegen score >22,
- increase in HR>30bpm; with no orthostatic fall in blood pressure.symptoms occuring in >3 months
Exclusion Criteria:
- pregnancy
- No cardiac or respiratory pathology
- Surgical history
- Participants in another research protocol
- Any other medical condition that confers greater morbidly than POTs (e.g.,active Cancer)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic Training
Progressive breathing training exercises for a period of 4 weeks, for 15 minutes twice daily.
As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced.
4 times a day followed by a sustained period of breathing control.
In addition to this Aerobic Training (cycling, treadmill) will also be practiced for 30 minutes constituting 5 days/ week.
Initial training would avoid upright position.
Mild-to-moderate-intensity endurance training, progressing from semi-recumbent to upright position plus strength training will be practiced.
|
Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily.
As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced.
4 times a day followed by a sustained period of breathing control.
In addition to this Aerobic Training (cycling, treadmill) will also be practiced for 30 minutes constituting 5 days/ week.
Initial training would avoid upright position.
Mild-to-moderate-intensity endurance training, progressing from semi-recumbent to upright position plus strength training will be practiced.
Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily.
As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced.
4 times a day followed by a sustained period of breathing control.
|
|
Active Comparator: Conventional Treatment
Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily.
As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced.
4 times a day followed by a sustained period of breathing control.
|
Progressive breathing retraining exercises for a period of 4 weeks, for 15 minutes twice daily.
As patients progressed to the seated posture, the controlled pause technique (exercise) will be introduced.
4 times a day followed by a sustained period of breathing control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nijmen Questionnaire ….dysfunctional breathing
Time Frame: 4 week.
|
This questionnaire is a self-report 16-symptom scale. The frequency of symptoms can be indicated by the following options (score): never (0), rarely (1), sometimes (2), often (3), and very often (4). This questionnaire was developed to screen individuals complaining of shortness of breath with several signs and symptoms of hyperventilation syndrome, such as tense feeling, dizziness, fast and deep breathing, feeling of tightness around the mouth, and anxiety. Readings will be at 0 week, after 2 week and after 4 week |
4 week.
|
|
Veterans specific activity questionnaire (VSAQ):
Time Frame: 4 week
|
The Veterans Specific Activity Questionnaire (VSAQ) is a 13-item self-administered symptom questionnaire that estimates aerobic fitness expressed in metabolic equivalents (METs). Aerobic capacity is measured in METs by the VSAQ. Readings will be at 0 week, after 2 week and after 4 week |
4 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Muriam Ghani, MSPT-CP, Riphah International University
Publications and helpful links
General Publications
- Abed H, Ball PA, Wang LX. Diagnosis and management of postural orthostatic tachycardia syndrome: A brief review. J Geriatr Cardiol. 2012 Mar;9(1):61-7. doi: 10.3724/SP.J.1263.2012.00061.
- Reilly CC, Floyd SV, Lee K, Warwick G, James S, Gall N, Rafferty GF. Breathlessness and dysfunctional breathing in patients with postural orthostatic tachycardia syndrome (POTS): The impact of a physiotherapy intervention. Auton Neurosci. 2020 Jan;223:102601. doi: 10.1016/j.autneu.2019.102601. Epub 2019 Nov 12.
- Deb A, Morgenshtern K, Culbertson CJ, Wang LB, Hohler AD. A survey-based analysis of symptoms in patients with postural orthostatic tachycardia syndrome. Proc (Bayl Univ Med Cent). 2015 Apr;28(2):157-9. doi: 10.1080/08998280.2015.11929217.
- Jarosz B. POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS): ITS RELEVANCE, AND IMPORTANCE, IN THE MANAGEMENT OF SPORT RELATED CONCUSSION. Chiropractic Journal of Australia. 2021;48(1):31-4.
- Raj SR, Guzman JC, Harvey P, Richer L, Schondorf R, Seifer C, Thibodeau-Jarry N, Sheldon RS. Canadian Cardiovascular Society Position Statement on Postural Orthostatic Tachycardia Syndrome (POTS) and Related Disorders of Chronic Orthostatic Intolerance. Can J Cardiol. 2020 Mar;36(3):357-372. doi: 10.1016/j.cjca.2019.12.024.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Respiratory Aspiration
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
Other Study ID Numbers
- REC/RCR&AHS/22/0320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postural Orthostatic Tachycardia Syndrome
-
Aristotle University Of ThessalonikiNot yet recruitingPostural Orthostatic Tachycardia Syndrome (POTS)
-
California State University, Dominguez HillsCompleted
-
Mayo ClinicCompletedPostural Tachycardia Syndrome | Postural Orthostatic Tachycardia Syndrome | Autonomic Dysfunction | POTS - Postural Orthostatic Tachycardia SyndromeUnited States
-
Cedars-Sinai Medical CenterNot yet recruitingPostural Orthostatic Tachycardia Syndrome (POTS)
-
Virginia Commonwealth UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPOTS - Postural Orthostatic Tachycardia SyndromeUnited States
-
University of CalgaryNot yet recruitingPostural Orthostatic Tachycardia Syndrome (POTS)
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPostural Tachycardia Syndrome (POTS)United States
-
Brigham and Women's HospitalFBRI LLC (F-Prime Capital)Active, not recruitingDysautonomia | Autonomic Dysfunction | POTS | POTS - Postural Orthostatic Tachycardia SyndromeUnited States
-
University of CalgaryRecruiting
-
Mayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingPostural Tachycardia SyndromeUnited States
Clinical Trials on Aerobic Training
-
University of BarcelonaCompleted
-
General Hospital Murska SobotaUniversity of Primorska; University of LjubljanaUnknownCoronary Artery Disease | Heart Failure With Reduced Ejection FractionSlovenia
-
Hadassah Medical OrganizationCompletedThe Influence of Different Training Regimens on Electrical Stability Following Myocardial InfarctionIschemic Heart Disease | Congestive Heart FailureIsrael
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtCompleted
-
Riphah International UniversityCompletedMyocardial InfarctionPakistan
-
Riphah International UniversityCompleted
-
Cardenal Herrera UniversityNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Duke UniversityCompleted
-
UNC Lineberger Comprehensive Cancer CenterCompletedStem Cell Transplantation, HematopoieticUnited States
-
University of GiessenHannover Medical SchoolUnknownType 2 DiabetesGermany