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

January 23, 2023 updated by: Riphah International University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Liaqat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hafiza Muriam Ghani, MSPT-CP, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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