AzTrials
AzTrials

Postural Orthostatic Tachycardia SyndromeNCT05404672

Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome

A study testing Aerobic Training and Conventional Treatment in people with Postural Orthostatic Tachycardia Syndrome, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Postural orthostatic tachycardia syndrome (POTS) is a chronic, multifactorial syndrome with complex symptoms of orthostatic intolerance. Of the major complaints are breathlessness and exercise intolerance. Read more about this study

Who is it for?
Ages 15 to 45 years, women only
What is being tested?
Aerobic Training and Conventional Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePakistan
Study dates
1 Jun 2022to 15 Jan 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 15 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Liaqat Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects Of Breathing Exercises With And Without Aerobic Training On Dysfunctional Breathing And Exercise Intolerance In Patients With Postural Orthostatic Tachycardia Syndrome

Postural orthostatic tachycardia syndrome (POTS) is a chronic, multifactorial syndrome with complex symptoms of orthostatic intolerance. Of the major complaints are breathlessness and exercise intolerance. The aim is to explore the potential impact of a physiotherapy intervention involving education and breathing control on dysfunctional breathing and improving exercise intolerance in POTS. The study would be a randomised controlled trial. Duration would be 4 week. Patients will be randomly divided into two groups by lottery method. Data will be collected through questionnaire from enrolled subjects in physical therapy department of Liaqat Hospital, Lahore. Experimental group will be treated by Progressive Breathing Retraining Exercise Program-2 times a day for 15 minutes, initially Controlled Nasal Breathing with progressively increasing the Controlled Pause, 4 times a day for 15 minutes, then both techniques will be performed together. In addition to this Aerobic training will be assigned to both the groups. Aerobic training will include cycling and treadmill- for 30 minutes\day for 5 days\week for 1 month. Total 20 sessions. While the controlled group will receive only aerobic training which will include cycling and treadmill for 30 minutes\day for 5 days\week for 1 month. Total 20 sessions. The dysfunctional breathing and exercise intolerance will be assessed through Nijmegen Questionnaire and Veterans Questionnaire respectively at 0 week, after 2 week and after 4 week. The data will be analyzed by spss version 25.

Being tested
Aerobic Training, Conventional Treatment
Keywords
Postural orthostatic tachycardia syndrome, Dysfunctional Breathing, Aerobic Training, Exercise Intolerance, Progressive Breathing Retraining
Medical subject headings
Postural Orthostatic Tachycardia Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic TrainingOther

    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.

  • Conventional TreatmentOther

    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.

Study groups in NCT05404672
Study groupRoleWhat they receive
Aerobic TrainingExperimentalProgressive 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.
Receives: Other: Aerobic Training; Other: Conventional Treatment
Conventional TreatmentActive comparatorProgressive 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.
Receives: Other: Conventional Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nijmen Questionnaire ….dysfunctional breathing

    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

    Measured: 4 week.

  2. Veterans specific activity questionnaire (VSAQ):

    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

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completion31 Dec 2022
  4. Study completion15 Jan 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404672
Sponsor's protocol ID
REC/RCR&AHS/22/0320
Status last verified
Jan 2023
First submitted
31 May 2022
Last updated
25 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22783324

  • 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.

    PubMed 31743851

  • 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.

    PubMed 25829642

  • 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.

    PubMed 32145864

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training and Conventional Treatment in people with Postural Orthostatic Tachycardia Syndrome, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nijmen Questionnaire ….dysfunctional breathing (time frame: 4 week.). The study lists 2 primary outcomes in all. 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 NCT05404672, which also lists 5 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 25 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in