NCT05404672

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 31, 2022

Last Update Submit

January 23, 2023

Conditions

Keywords

Postural orthostatic tachycardia syndromeDysfunctional BreathingAerobic TrainingExercise IntoleranceProgressive Breathing Retraining

Outcome Measures

Primary Outcomes (2)

  • 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

    4 week.

  • 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

    4 week

Study Arms (2)

Aerobic Training

EXPERIMENTAL

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.

Other: Aerobic TrainingOther: Conventional Treatment

Conventional Treatment

ACTIVE COMPARATOR

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.

Other: Conventional Treatment

Interventions

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.

Aerobic Training

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.

Aerobic TrainingConventional Treatment

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaqat Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 22783324BACKGROUND
  • 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.

    PMID: 31743851BACKGROUND
  • 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.

    PMID: 25829642BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32145864BACKGROUND
  • Dani M, Fedorowski A. Tackling POTS Needs More Than Just a Sympathetic Approach. Hypertension. 2024 Nov;81(11):2248-2250. doi: 10.1161/HYPERTENSIONAHA.124.23716. Epub 2024 Oct 16. No abstract available.

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Study Officials

  • Hafiza Muriam Ghani, MSPT-CP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 15, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations